Anti-Aging Proof of Concept Study:
Results and Summary
Anti-Aging Proof of Concept Study:
Results and Summary
Suzanne Bruce, MD*, Jwala Karnik, MD**, Laurence Dryer, PhD***, David Burkholder, PhD****
Suzanne Bruce, MD*, Jwala Karnik, MD**, Laurence Dryer, PhD***, David Burkholder, PhD****
*The Center for Skin Research, Suzanne Bruce and Associates, Houston, TX,
**Suneva Medical, Inc., Santa Barbara, CA
***Obagi Medical Products, Inc., Long Beach, CA,
****PD Pharmaceutical Consulting, Guilford, CT
*The Center for Skin Research, Suzanne Bruce and Associates, Houston, TX,
**Suneva Medical, Inc., Santa Barbara, CA
***Obagi Medical Products, Inc., Long Beach, CA,
****PD Pharmaceutical Consulting, Guilford, CT
Address for Correspondence:
Jwala Karnik, MD
Suneva Medical
5383 Hollister Ave., Suite 260
Santa Barbara, CA 93111
[email protected]
Address for Correspondence:
Jwala Karnik, MD
Suneva Medical
5383 Hollister Ave., Suite 260
Santa Barbara, CA 93111
[email protected]
ABSTRACT
ABSTRACT
Methods: Female subjects age 35-65; Fitzpatrick Skin Type I-IV; with moderate amounts of photodamage, fine lines,
and wrinkles used ReGenica® Overnight Repair and ReGenica® Day Repair SPF 15 for 3 months. At each visit,
photos were taken of subjects while an Investigator completed skin grading assessments and subjects completed
self-assessments. Investigator assessments included evaluation of tactile roughness, visual texture, wrinkles,
blotchiness, skin tone evenness, radiance, and translucence on a 5 point scale. Subjects’ self-assessments included
assessment of fine lines and wrinkles, firmness, evenness of skin tone, brightness, resilience, clarity and radiance.
Changes from baseline were evaluated for each parameter and p values for changes from baseline to each study
visit for investigator’s assessments and to end-of-study for self-assessments were calculated.
Methods: Female subjects age 35-65; Fitzpatrick Skin Type I-IV; with moderate amounts of photodamage, fine lines,
and wrinkles used ReGenica® Overnight Repair and ReGenica® Day Repair SPF 15 for 3 months. At each visit,
photos were taken of subjects while an Investigator completed skin grading assessments and subjects completed
self-assessments. Investigator assessments included evaluation of tactile roughness, visual texture, wrinkles,
blotchiness, skin tone evenness, radiance, and translucence on a 5 point scale. Subjects’ self-assessments included
assessment of fine lines and wrinkles, firmness, evenness of skin tone, brightness, resilience, clarity and radiance.
Changes from baseline were evaluated for each parameter and p values for changes from baseline to each study
visit for investigator’s assessments and to end-of-study for self-assessments were calculated.
Results: Eighteen of 21 enrolled female subjects completed the study. Three subjects chose to drop from the study.
Statistically significant improvements in investigator assessments of tactile roughness, visual texture, wrinkles,
blotchiness, skin tone evenness, radiance and translucency compared to baseline were observed at Weeks 4, 8 and
12 after initiating treatments. Progressive improvement was seen through the last study visit (Visit 5, Week 12). Similar statistically significant improvements in subjects’ self-assessments were seen comparing the first post-baseline
visit (Visit 2, Week 2) to subsequent visits. More than 93.5% of subjects agreed (somewhat or strongly) with all of the
positive subject assessment statements at Week 12. Importantly, 100% of subjects indicated at the end of the study
that they would recommend the product to a friend and would want to purchase the product. No treatment-related
adverse events were recorded during the study.
Results: Eighteen of 21 enrolled female subjects completed the study. Three subjects chose to drop from the study.
Statistically significant improvements in investigator assessments of tactile roughness, visual texture, wrinkles,
blotchiness, skin tone evenness, radiance and translucency compared to baseline were observed at Weeks 4, 8 and
12 after initiating treatments. Progressive improvement was seen through the last study visit (Visit 5, Week 12). Similar statistically significant improvements in subjects’ self-assessments were seen comparing the first post-baseline
visit (Visit 2, Week 2) to subsequent visits. More than 93.5% of subjects agreed (somewhat or strongly) with all of the
positive subject assessment statements at Week 12. Importantly, 100% of subjects indicated at the end of the study
that they would recommend the product to a friend and would want to purchase the product. No treatment-related
adverse events were recorded during the study.
Conclusions: ReGenica was safe and clinically effective in reducing anti-aging effects in this group of female subjects aged 35–65 years as measured by both investigator assessments and subjects’ self-assessments.
Conclusions: ReGenica was safe and clinically effective in reducing anti-aging effects in this group of female subjects aged 35–65 years as measured by both investigator assessments and subjects’ self-assessments.
INTRODUCTION
INTRODUCTION
Prenatal (fetal) tissue has been shown to possess healing characteristics and regenerative effects.5 A proprietary
tissue engineering technology has been developed to create an environment that triggers neonatal cells to produce
a soluble human extracellular matrix material in cell-conditioned media along with a variety of growth factors and
cytokines.6 Neonatal cells are anchored on microbeads under conditions of low oxygen tension. They subsequently produce growth factors and cytokines that can be seen in fetal cells. The resulting media is known as human
cell-conditioned media (hCCM) and the growth factors and cytokines have been suggested to play key roles in
wound healing.7-10 The hCCM has been incorporated into a topical preparation (ReGenica®, Suneva Medical, Inc.)
for potential use in wound healing (after laser resurfacing procedures) and improving the appearance of aging skin.
Prenatal (fetal) tissue has been shown to possess healing characteristics and regenerative effects.5 A proprietary
tissue engineering technology has been developed to create an environment that triggers neonatal cells to produce
a soluble human extracellular matrix material in cell-conditioned media along with a variety of growth factors and
cytokines.6 Neonatal cells are anchored on microbeads under conditions of low oxygen tension. They subsequently produce growth factors and cytokines that can be seen in fetal cells. The resulting media is known as human
cell-conditioned media (hCCM) and the growth factors and cytokines have been suggested to play key roles in
wound healing.7-10 The hCCM has been incorporated into a topical preparation (ReGenica®, Suneva Medical, Inc.)
for potential use in wound healing (after laser resurfacing procedures) and improving the appearance of aging skin.
Two clinical studies have demonstrated the ability of the growth factors in ReGenica to support and improve healing
time in subjects after laser resurfacing.6, 11 An additional placebo controlled clinical trial of ReGenica was completed
and the results suggested potential for ReGenica to mitigate the effects of aging facial skin.12 Based on these promising results, the current anti-aging study was undertaken to provide further evidence of the safety and effectiveness
of ReGenica in improving the appearance of aging skin.
Two clinical studies have demonstrated the ability of the growth factors in ReGenica to support and improve healing
time in subjects after laser resurfacing.6, 11 An additional placebo controlled clinical trial of ReGenica was completed
and the results suggested potential for ReGenica to mitigate the effects of aging facial skin.12 Based on these promising results, the current anti-aging study was undertaken to provide further evidence of the safety and effectiveness
of ReGenica in improving the appearance of aging skin.
Background and Objectives: The etiology of aging human skin includes intrinsic physiologic changes greatly
accelerated by photoaging, predominantly through exposure to UV light. Consumer interest and demand for antiaging skin care products is extremely high especially in light of aging populations. Prenatal (fetal) tissue has been
shown to possess healing characteristics and regenerative effects. A proprietary tissue engineering technology
has been developed to produce a soluble human extracellular matrix material and cell-conditioned media with
growth factors and proteins. Neonatal cells are cultured on microbeads under conditions of low oxygen tension.
This resulting human cell-conditioned media (hCCM) contains a variety of growth factors and cytokines similar
to those found in fetal cells and has been incorporated into a topical preparation for use in facial wound healing
(after laser resurfacing procedures) and improving the appearance of aging skin. The objective of this study was
to observe the effects of an hCCM-containing topical skincare regimen on subjects with demonstrated aging skin
damage (photodamage) when used consistently over a 3 month time period.
ABSTRACT
Background and Objectives: The etiology of aging human skin includes intrinsic physiologic changes greatly
accelerated by photoaging, predominantly through exposure to UV light. Consumer interest and demand for antiaging skin care products is extremely high especially in light of aging populations. Prenatal (fetal) tissue has been
shown to possess healing characteristics and regenerative effects. A proprietary tissue engineering technology
has been developed to produce a soluble human extracellular matrix material and cell-conditioned media with
growth factors and proteins. Neonatal cells are cultured on microbeads under conditions of low oxygen tension.
This resulting human cell-conditioned media (hCCM) contains a variety of growth factors and cytokines similar
to those found in fetal cells and has been incorporated into a topical preparation for use in facial wound healing
(after laser resurfacing procedures) and improving the appearance of aging skin. The objective of this study was
to observe the effects of an hCCM-containing topical skincare regimen on subjects with demonstrated aging skin
damage (photodamage) when used consistently over a 3 month time period.
Methods: Female subjects age 35-65; Fitzpatrick Skin Type I-IV; with moderate amounts of photodamage, fine lines,
and wrinkles used ReGenica® Overnight Repair and ReGenica® Day Repair SPF 15 for 3 months. At each visit,
photos were taken of subjects while an Investigator completed skin grading assessments and subjects completed
self-assessments. Investigator assessments included evaluation of tactile roughness, visual texture, wrinkles,
blotchiness, skin tone evenness, radiance, and translucence on a 5 point scale. Subjects’ self-assessments included
assessment of fine lines and wrinkles, firmness, evenness of skin tone, brightness, resilience, clarity and radiance.
Changes from baseline were evaluated for each parameter and p values for changes from baseline to each study
visit for investigator’s assessments and to end-of-study for self-assessments were calculated.
Results: Eighteen of 21 enrolled female subjects completed the study. Three subjects chose to drop from the study.
Statistically significant improvements in investigator assessments of tactile roughness, visual texture, wrinkles,
blotchiness, skin tone evenness, radiance and translucency compared to baseline were observed at Weeks 4, 8 and
12 after initiating treatments. Progressive improvement was seen through the last study visit (Visit 5, Week 12). Similar statistically significant improvements in subjects’ self-assessments were seen comparing the first post-baseline
visit (Visit 2, Week 2) to subsequent visits. More than 93.5% of subjects agreed (somewhat or strongly) with all of the
positive subject assessment statements at Week 12. Importantly, 100% of subjects indicated at the end of the study
that they would recommend the product to a friend and would want to purchase the product. No treatment-related
adverse events were recorded during the study.
Conclusions: ReGenica was safe and clinically effective in reducing anti-aging effects in this group of female subjects aged 35–65 years as measured by both investigator assessments and subjects’ self-assessments.
INTRODUCTION
The function and appearance of human skin degenerates as part of the intrinsic (chronological) aging process. The
effects of environmental factors (sun, heat, pollution, smoking) and most importantly, solar ultraviolet light (UV)
contribute to the superimposed photoaging process.1, 2 Aging and photodamaged skin are characterized by fine and
course wrinkles, dyspigmentation, sallow color, dry texture and loss-of-tone.1, 3 Consumer interest and demand for
anti-aging treatments including medical, surgical and cosmetic approaches is extremely high in part because of the
aging population.2, 4
Prenatal (fetal) tissue has been shown to possess healing characteristics and regenerative effects.5 A proprietary
tissue engineering technology has been developed to create an environment that triggers neonatal cells to produce
a soluble human extracellular matrix material in cell-conditioned media along with a variety of growth factors and
cytokines.6 Neonatal cells are anchored on microbeads under conditions of low oxygen tension. They subsequently produce growth factors and cytokines that can be seen in fetal cells. The resulting media is known as human
cell-conditioned media (hCCM) and the growth factors and cytokines have been suggested to play key roles in
wound healing.7-10 The hCCM has been incorporated into a topical preparation (ReGenica®, Suneva Medical, Inc.)
for potential use in wound healing (after laser resurfacing procedures) and improving the appearance of aging skin.
Two clinical studies have demonstrated the ability of the growth factors in ReGenica to support and improve healing
time in subjects after laser resurfacing.6, 11 An additional placebo controlled clinical trial of ReGenica was completed
and the results suggested potential for ReGenica to mitigate the effects of aging facial skin.12 Based on these promising results, the current anti-aging study was undertaken to provide further evidence of the safety and effectiveness
of ReGenica in improving the appearance of aging skin.
1
2
The function and appearance of human skin degenerates as part of the intrinsic (chronological) aging process. The
effects of environmental factors (sun, heat, pollution, smoking) and most importantly, solar ultraviolet light (UV)
contribute to the superimposed photoaging process.1, 2 Aging and photodamaged skin are characterized by fine and
course wrinkles, dyspigmentation, sallow color, dry texture and loss-of-tone.1, 3 Consumer interest and demand for
anti-aging treatments including medical, surgical and cosmetic approaches is extremely high in part because of the
aging population.2, 4
1
Background and Objectives: The etiology of aging human skin includes intrinsic physiologic changes greatly
accelerated by photoaging, predominantly through exposure to UV light. Consumer interest and demand for antiaging skin care products is extremely high especially in light of aging populations. Prenatal (fetal) tissue has been
shown to possess healing characteristics and regenerative effects. A proprietary tissue engineering technology
has been developed to produce a soluble human extracellular matrix material and cell-conditioned media with
growth factors and proteins. Neonatal cells are cultured on microbeads under conditions of low oxygen tension.
This resulting human cell-conditioned media (hCCM) contains a variety of growth factors and cytokines similar
to those found in fetal cells and has been incorporated into a topical preparation for use in facial wound healing
(after laser resurfacing procedures) and improving the appearance of aging skin. The objective of this study was
to observe the effects of an hCCM-containing topical skincare regimen on subjects with demonstrated aging skin
damage (photodamage) when used consistently over a 3 month time period.
The function and appearance of human skin degenerates as part of the intrinsic (chronological) aging process. The
effects of environmental factors (sun, heat, pollution, smoking) and most importantly, solar ultraviolet light (UV)
contribute to the superimposed photoaging process.1, 2 Aging and photodamaged skin are characterized by fine and
course wrinkles, dyspigmentation, sallow color, dry texture and loss-of-tone.1, 3 Consumer interest and demand for
anti-aging treatments including medical, surgical and cosmetic approaches is extremely high in part because of the
aging population.2, 4
2
1
MATERIALS AND METHODS
MATERIALS AND METHODS
Subjects were excluded from the study if they had known hypersensitivity to any components of the ReGenica
products, were taking oral retinoids or used any of the following in the preceding 6 months: any laser, IPL or tightening treatments, toxins, fillers, chemical peels, or microdermabrasion. Use of topical retinoids or any growth factor
product or alpha or beta hydroxy acids were prohibited within the previous month. Subjects also had no significant
history of eczema, atopic dermatitis, or psoriasis, any active facial inflammatory condition and were not pregnant
or breast-feeding.
Subjects were excluded from the study if they had known hypersensitivity to any components of the ReGenica
products, were taking oral retinoids or used any of the following in the preceding 6 months: any laser, IPL or tightening treatments, toxins, fillers, chemical peels, or microdermabrasion. Use of topical retinoids or any growth factor
product or alpha or beta hydroxy acids were prohibited within the previous month. Subjects also had no significant
history of eczema, atopic dermatitis, or psoriasis, any active facial inflammatory condition and were not pregnant
or breast-feeding.
Study Procedures and Assessments
Subjects were seen at baseline (Day 1) and Weeks 2, 4, 8 and 12. At the baseline visit, after signing informed consents and the photo releases, subjects were given products (ReGenica Overnight Repair and ReGenica Day Repair
SPF 15) and instructions for their use. Instructions for use (provided in the product consumer information brochure) included: ReGenica Overnight Repair - ‘In the evening after cleansing, gently massage a dime-size amount of
ReGenica Overnight Repair over face, neck, and décolletage; ReGenica Day Repair SPF 15 - In the morning after
cleansing, gently massage a dime-sized amount of ReGenica Day Repair SPF 15 over face, neck, and décolletage’.
Study Procedures and Assessments
Subjects were seen at baseline (Day 1) and Weeks 2, 4, 8 and 12. At the baseline visit, after signing informed consents and the photo releases, subjects were given products (ReGenica Overnight Repair and ReGenica Day Repair
SPF 15) and instructions for their use. Instructions for use (provided in the product consumer information brochure) included: ReGenica Overnight Repair - ‘In the evening after cleansing, gently massage a dime-size amount of
ReGenica Overnight Repair over face, neck, and décolletage; ReGenica Day Repair SPF 15 - In the morning after
cleansing, gently massage a dime-sized amount of ReGenica Day Repair SPF 15 over face, neck, and décolletage’.
At all visits, photos were taken of subjects and forwarded to the sponsor for evaluation. At all visits, the investigator
completed the skin grading assessment using a 5 point scale (0= none, 1= minimal, 2= mild, 3= moderate, 4= severe)
to grade tactile roughness, visual texture, wrinkles and blotchiness. An additional 5 point scale (0-4, 0 being worst
possible results and 4 being the best possible results) was used by the investigator to grade skin tone evenness,
radiance and translucency. Subject self-assessments, completed at Visit 2–5, consisted of 20 questions related to
overall satisfaction with product and specific facial and skin properties. Adverse events were assessed at each visit.
At all visits, photos were taken of subjects and forwarded to the sponsor for evaluation. At all visits, the investigator
completed the skin grading assessment using a 5 point scale (0= none, 1= minimal, 2= mild, 3= moderate, 4= severe)
to grade tactile roughness, visual texture, wrinkles and blotchiness. An additional 5 point scale (0-4, 0 being worst
possible results and 4 being the best possible results) was used by the investigator to grade skin tone evenness,
radiance and translucency. Subject self-assessments, completed at Visit 2–5, consisted of 20 questions related to
overall satisfaction with product and specific facial and skin properties. Adverse events were assessed at each visit.
Photography
Subjects removed all makeup including eye makeup and lipstick as well as all jewelry. Subjects’ faces were wiped
with make-up remover to remove any residual makeup and blotting papers were applied to eliminate shine. All hair
was cleared away from the face with a headband and a black drape was placed over subject’s clothes. Using the
VISIA (Canfield Scientific, Inc.) camera system, the stool height was adjusted so the subject was sitting up straight
and had a neutral, relaxed facial expression with eyes open. Each subject had a frontal, right oblique, and left
oblique picture taken.
Photography
Subjects removed all makeup including eye makeup and lipstick as well as all jewelry. Subjects’ faces were wiped
with make-up remover to remove any residual makeup and blotting papers were applied to eliminate shine. All hair
was cleared away from the face with a headband and a black drape was placed over subject’s clothes. Using the
VISIA (Canfield Scientific, Inc.) camera system, the stool height was adjusted so the subject was sitting up straight
and had a neutral, relaxed facial expression with eyes open. Each subject had a frontal, right oblique, and left
oblique picture taken.
RESULTS
RESULTS
Investigator Assessments
Figure 1 summarizes the consistent improvements for parameters related to skin smoothness, overall tone, and
radiance/translucency. The measurements of smoothness (tactile roughness, texture, wrinkles) significantly
improved with respect to baseline as early as 2 weeks (p<0.05) and continued to advance to reach 44.9%, 46.2%
and 29.2% improvement over baseline, respectively, at 12 weeks. The measurements of evenness (blotchiness and
skin tone) also improved at 2 weeks and reached 42.9% and 65.2% improvement over baseline, respectively, at 12
weeks. Finally, improvements in investigator assessments of radiance and translucency were highly statistically
significant as early as 4 weeks and continued to improve to 91.1% and 63.1%, compared to baseline respectively, by
12 weeks. Table 1 displays the average score changes and percent improvements over baseline with corresponding
95% confidence intervals for each investigator assessment category. Overall, these results suggest that the investigator observed progressive improvement in skin smoothness and evenness and that subjects’ skin appeared more
glowing during the course of the 12 weeks of treatment.
Investigator Assessments
Figure 1 summarizes the consistent improvements for parameters related to skin smoothness, overall tone, and
radiance/translucency. The measurements of smoothness (tactile roughness, texture, wrinkles) significantly
improved with respect to baseline as early as 2 weeks (p<0.05) and continued to advance to reach 44.9%, 46.2%
and 29.2% improvement over baseline, respectively, at 12 weeks. The measurements of evenness (blotchiness and
skin tone) also improved at 2 weeks and reached 42.9% and 65.2% improvement over baseline, respectively, at 12
weeks. Finally, improvements in investigator assessments of radiance and translucency were highly statistically
significant as early as 4 weeks and continued to improve to 91.1% and 63.1%, compared to baseline respectively, by
12 weeks. Table 1 displays the average score changes and percent improvements over baseline with corresponding
95% confidence intervals for each investigator assessment category. Overall, these results suggest that the investigator observed progressive improvement in skin smoothness and evenness and that subjects’ skin appeared more
glowing during the course of the 12 weeks of treatment.
2
2
Subjects
Female subjects between the ages of 35–65; Fitzpatrick Skin Type I–IV; with moderate amount of photodamage, fine
lines and wrinkles as assessed by the investigator and sponsor were enrolled in the study. Subjects were required
to sign informed consent prior to study enrollment. Additional inclusion criteria included willingness to withhold
use of all other topical skincare products during the study except facial cleansers, Latisse® ([bimatoprost ophthalmic solution] 0.03%) and make-up. Subjects had to withhold all facial treatments during the course of the study
including toxins, fillers, microdermabrasion, intense pulsed light (IPL), chemical peels, facials, laser treatments
and tightening treatments. Waxing and threading was allowed but facial laser hair removal was not. Subjects were
asked to remove all makeup at every visit for pictures and had to sign a photo release.
Eighteen female subjects ages 35–65 met the inclusion/exclusion criteria and completed all 5 scheduled study visits.
1
Subjects
Female subjects between the ages of 35–65; Fitzpatrick Skin Type I–IV; with moderate amount of photodamage, fine
lines and wrinkles as assessed by the investigator and sponsor were enrolled in the study. Subjects were required
to sign informed consent prior to study enrollment. Additional inclusion criteria included willingness to withhold
use of all other topical skincare products during the study except facial cleansers, Latisse® ([bimatoprost ophthalmic solution] 0.03%) and make-up. Subjects had to withhold all facial treatments during the course of the study
including toxins, fillers, microdermabrasion, intense pulsed light (IPL), chemical peels, facials, laser treatments
and tightening treatments. Waxing and threading was allowed but facial laser hair removal was not. Subjects were
asked to remove all makeup at every visit for pictures and had to sign a photo release.
Eighteen female subjects ages 35–65 met the inclusion/exclusion criteria and completed all 5 scheduled study visits.
Subject Self-Assessments
Table 2 and Figure 2 summarize subjects’ perceptions of treatment effects at each visit by their agreement (agree
somewhat or agree strongly) with the positive statements on the subject questionnaire. Subjects saw marked improvement as early as two weeks, confirming the early results noted by the Investigator. The percentage of subjects
who agreed somewhat or strongly with most of the self-assessment statements reached nearly 70% as early as 2
weeks. By 4 weeks, subjects had reached nearly full improvement as the percentage of subjects who agreed with
the majority of statements quickly rose to more than 85% at 4 weeks and reached 93.5% for most questions by
week 12. Also by 12 weeks of treatment, all of the subjects (100%) agreed that “My skin brightness has increased”,
“My skin looks refreshed”, and “My skin looks more healthy”. Figures 2A and 2B illustrate the dramatic increases in
subjects’ positive agreements with each statement by 2 weeks and the striking maximum responses at 12 weeks.
Subject Self-Assessments
Table 2 and Figure 2 summarize subjects’ perceptions of treatment effects at each visit by their agreement (agree
somewhat or agree strongly) with the positive statements on the subject questionnaire. Subjects saw marked improvement as early as two weeks, confirming the early results noted by the Investigator. The percentage of subjects
who agreed somewhat or strongly with most of the self-assessment statements reached nearly 70% as early as 2
weeks. By 4 weeks, subjects had reached nearly full improvement as the percentage of subjects who agreed with
the majority of statements quickly rose to more than 85% at 4 weeks and reached 93.5% for most questions by
week 12. Also by 12 weeks of treatment, all of the subjects (100%) agreed that “My skin brightness has increased”,
“My skin looks refreshed”, and “My skin looks more healthy”. Figures 2A and 2B illustrate the dramatic increases in
subjects’ positive agreements with each statement by 2 weeks and the striking maximum responses at 12 weeks.
Table 3 demonstrates that after 3 months of continuous treatment with ReGenica, 100% of subjects would recommend the product to a friend; would want to purchase the product if available and were satisfied with the product’s
texture, color and smell.
Table 3 demonstrates that after 3 months of continuous treatment with ReGenica, 100% of subjects would recommend the product to a friend; would want to purchase the product if available and were satisfied with the product’s
texture, color and smell.
Photographic Documentation of Improved Skin Appearance
Figure 3 displays representative photographs of 4 subjects taken at baseline and at Week 2 or Week 4 after starting
treatments with ReGenica. Left oblique views are shown for the same subject at Week 2 in Figure 3, Panel A. Consistent improvements compared to baseline in skin tone, blotchiness and texture were seen on this subject’s face.
Figure 3, Panel B shows left oblique views of a subject with notable reduction in wrinkles at Week 2 compared to
baseline. Fontal views of the subject in Figure 3, Panel C taken at Week 4 show prominent improvements in skin
tone, texture, and radiance compared to baseline. Figure 3, Panel D demonstrates general improvement of multiple
features on the right side of the face at Week 4. These include reduced wrinkles, smoother texture, reduced blotchiness and enhanced skin tone and radiance.
Photographic Documentation of Improved Skin Appearance
Figure 3 displays representative photographs of 4 subjects taken at baseline and at Week 2 or Week 4 after starting
treatments with ReGenica. Left oblique views are shown for the same subject at Week 2 in Figure 3, Panel A. Consistent improvements compared to baseline in skin tone, blotchiness and texture were seen on this subject’s face.
Figure 3, Panel B shows left oblique views of a subject with notable reduction in wrinkles at Week 2 compared to
baseline. Fontal views of the subject in Figure 3, Panel C taken at Week 4 show prominent improvements in skin
tone, texture, and radiance compared to baseline. Figure 3, Panel D demonstrates general improvement of multiple
features on the right side of the face at Week 4. These include reduced wrinkles, smoother texture, reduced blotchiness and enhanced skin tone and radiance.
Subjects’ Disposition and Safety
Twenty-one female subjects ages 35–65 were screened, met the inclusion/exclusion criteria and were enrolled in the
study. Eighteen subjects completed all 5 scheduled study visits; 2 subjects completed Visit 2 and chose to discontinue study participation. The third subject, who was on a detoxification program, reported mild dizziness at Visit 3
and decided to discontinue from the study. The dizziness resolved and was not considered related to the treatment.
Subjects’ Disposition and Safety
Twenty-one female subjects ages 35–65 were screened, met the inclusion/exclusion criteria and were enrolled in the
study. Eighteen subjects completed all 5 scheduled study visits; 2 subjects completed Visit 2 and chose to discontinue study participation. The third subject, who was on a detoxification program, reported mild dizziness at Visit 3
and decided to discontinue from the study. The dizziness resolved and was not considered related to the treatment.
Three additional subjects reported adverse events during the 3 month study. One subject had a fever blister treated with Valtrex® (valacyclovir) which resolved, one subject had a moderate eye infection which was treated with
gentamicin and was ongoing at study completion, and one subject had a common cold followed by a urinary tract
infection which was treated with ciprofloxacin and resolved. None of the adverse events were considered related to
treatment and all three of these subjects completed the study.
Three additional subjects reported adverse events during the 3 month study. One subject had a fever blister treated with Valtrex® (valacyclovir) which resolved, one subject had a moderate eye infection which was treated with
gentamicin and was ongoing at study completion, and one subject had a common cold followed by a urinary tract
infection which was treated with ciprofloxacin and resolved. None of the adverse events were considered related to
treatment and all three of these subjects completed the study.
DISCUSSION
DISCUSSION
ReGenica is a topical gel preparation enriched with human cell-conditioned media (hCCM) that contains a variety
of growth factors and cytokines.7-10 hCCM is produced by culturing neonatal fibroblasts on dextran microcarrier
beads under hypoxic conditions.11 Compounds secreted within the hypoxic cultures were similar to factors known
to promote scarless wound-healing.11 These findings and others led to the hypotheses that the topical skin care
preparation containing hCCM might mitigate post laser symptoms (erythema, edema, and flaking of the skin) and
prove valuable in improving the appearance of aging and photoaged skin. Clinical trials proceeded to test both
hypotheses.
ReGenica is a topical gel preparation enriched with human cell-conditioned media (hCCM) that contains a variety
of growth factors and cytokines.7-10 hCCM is produced by culturing neonatal fibroblasts on dextran microcarrier
beads under hypoxic conditions.11 Compounds secreted within the hypoxic cultures were similar to factors known
to promote scarless wound-healing.11 These findings and others led to the hypotheses that the topical skin care
preparation containing hCCM might mitigate post laser symptoms (erythema, edema, and flaking of the skin) and
prove valuable in improving the appearance of aging and photoaged skin. Clinical trials proceeded to test both
hypotheses.
An initial full-face post laser study was followed by a split-face design post laser study and both studies indicated
reduced erythema, more rapid recovery of the skin barrier (reepithelialization) and overall improved results for
subjects treated with hCCM compared to placebo (vehicle).6, 11 No cutaneous safety concerns (e.g. irritant/allergic
dermatitis) occurred over the course of either study. The promising results from the post laser studies suggested
that the formulation containing the hCCM may have benefits for treating other types of dermatologic conditions,
specifically aging and photoaged skin for the present study.
An initial full-face post laser study was followed by a split-face design post laser study and both studies indicated
reduced erythema, more rapid recovery of the skin barrier (reepithelialization) and overall improved results for
subjects treated with hCCM compared to placebo (vehicle).6, 11 No cutaneous safety concerns (e.g. irritant/allergic
dermatitis) occurred over the course of either study. The promising results from the post laser studies suggested
that the formulation containing the hCCM may have benefits for treating other types of dermatologic conditions,
specifically aging and photoaged skin for the present study.
Statistics reported by the American Society of Plastic Surgeons supports the view that consumer interest and demand for anti-aging treatments including medical, surgical and cosmetic approaches is extremely high. In 2012, 13
million cosmetic minimally-invasive procedures were performed, an increase of 6% from 2011.4 The availability of a
topical product that could provide notable improvement in aged skin appearance would have clear benefits. The first
ReGenica anti-aging study was a double-blind placebo controlled comparative study of ReGenica and Vehicle con-
Statistics reported by the American Society of Plastic Surgeons supports the view that consumer interest and demand for anti-aging treatments including medical, surgical and cosmetic approaches is extremely high. In 2012, 13
million cosmetic minimally-invasive procedures were performed, an increase of 6% from 2011.4 The availability of a
topical product that could provide notable improvement in aged skin appearance would have clear benefits. The first
ReGenica anti-aging study was a double-blind placebo controlled comparative study of ReGenica and Vehicle con-
3
4
3
trol (applied morning and night). Both investigator blinded assessments and subject self-assessments indicated improved skin appearance and texture during the 10 week study.12 The present anti-aging study was intended to build
on the results of the first ReGenica anti-aging study. Consistent and important improvements from baseline in investigator assessments for parameters related to skin smoothness, tone and radiance/translucency were observed
throughout the 3 month study. Average improvements 2 weeks after beginning treatments were statistically better
than at baseline for tactile roughness, texture, wrinkles and blotchiness. In addition, every parameter progressively
improved across visits up to and including the final visit at 12 weeks. The improvement in investigator assessments
was confirmed by observation of improvements in subjects’ appearance in photographs taken at baseline and each
subsequent study visit.
trol (applied morning and night). Both investigator blinded assessments and subject self-assessments indicated improved skin appearance and texture during the 10 week study.12 The present anti-aging study was intended to build
on the results of the first ReGenica anti-aging study. Consistent and important improvements from baseline in investigator assessments for parameters related to skin smoothness, tone and radiance/translucency were observed
throughout the 3 month study. Average improvements 2 weeks after beginning treatments were statistically better
than at baseline for tactile roughness, texture, wrinkles and blotchiness. In addition, every parameter progressively
improved across visits up to and including the final visit at 12 weeks. The improvement in investigator assessments
was confirmed by observation of improvements in subjects’ appearance in photographs taken at baseline and each
subsequent study visit.
The improvements in appearance reported by the investigator were reinforced by improvements in subject self-assessments. Subject self-assessment improvements were notable by 2 weeks, reached almost the full amount of
improvement by 4 weeks and reached a high level by 12 weeks. Also by 12 weeks, 100% of subjects agreed that
“My skin brightness has increased”, “My skin looks refreshed”, and “My skin feels more healthy”. Over ninety three
(93.5%) of subjects agreed (somewhat or strongly) with the majority of the positive subject assessment statements
at 12 weeks such as “My skin tone has become more even”, “My line and wrinkles are less visible”, and “My skin feels
more firm”. Importantly, 100% of subjects indicated at the end of the study that they would recommend the product
to a friend and would want to purchase the product if available. In addition, all subjects indicated they were satisfied
with the product’s texture, color and smell at the end of the study.
The improvements in appearance reported by the investigator were reinforced by improvements in subject self-assessments. Subject self-assessment improvements were notable by 2 weeks, reached almost the full amount of
improvement by 4 weeks and reached a high level by 12 weeks. Also by 12 weeks, 100% of subjects agreed that
“My skin brightness has increased”, “My skin looks refreshed”, and “My skin feels more healthy”. Over ninety three
(93.5%) of subjects agreed (somewhat or strongly) with the majority of the positive subject assessment statements
at 12 weeks such as “My skin tone has become more even”, “My line and wrinkles are less visible”, and “My skin feels
more firm”. Importantly, 100% of subjects indicated at the end of the study that they would recommend the product
to a friend and would want to purchase the product if available. In addition, all subjects indicated they were satisfied
with the product’s texture, color and smell at the end of the study.
Overall, by both investigator assessments and subject self-assessments, a skincare regimen including ReGenica
Overnight Repair and ReGenica Day Repair SPF 15 resulted in significant benefits in skin health and appearance
with no attendant safety issues.
Overall, by both investigator assessments and subject self-assessments, a skincare regimen including ReGenica
Overnight Repair and ReGenica Day Repair SPF 15 resulted in significant benefits in skin health and appearance
with no attendant safety issues.
CONCLUSIONS
CONCLUSIONS
REFERENCES
REFERENCES
2.
3.
2.
3.
In this clinical trial, ReGenica Overnight Repair and ReGenica Day Repair SPF 15, formulations containing human
cell-conditioned media, applied daily during the 90 day study, resulted in highly statistically significant improvements in skin tactile roughness, texture, wrinkles, blotchiness, skin tone evenness, radiance and translucency as
measured by investigator assessments and supported by subjects’ self-assessments. Improvements noted by both
the investigator and subjects were noted rapidly (by 2 weeks), rose significantly to almost the full benefit by 4
weeks, and reached a high level by 12 weeks (end-of-study). ReGenica may provide significant benefit to consumers
seeking non-invasive measures to mitigate the effect of aging.
1.
4.
5.
6.
7.
8.
9.
10.
11.
12.
Chung, J., Cho, S., Kang, S. Why does the skin age? Intrinsic againg, photoaging, and their pathophysiology. In
D. S. Rigel, R. A. Weiss, H. W. Lim, et al. (Eds.), Photoaging, 1st Ed. New York: Marcel Dekker, Inc., 2004. Pp. 1-13.
Gilchrest, B. A. Photoaging. The Journal of Investigative Dermatology 133: E2-6, 2013.
Kligman, A. M. Early destructive effect of sunlight on human skin. JAMA: The Journal of the American Medical
Association 210: 2377-2380, 1969.
2012 Plastic Surgery Statistics Reports. American Society of Plastic Surgeons.
Adzick, N. S., Lorenz, H. P. Cells, matrix, growth factors, and the surgeon. The biology of scarless fetal wound
repair. Annals of Surgery 220: 10-18, 1994.
Zimber, M. P., Mansbridge, J. N., Taylor, M., et al. Human cell-conditioned media produced under embryonic-like
conditions result in improved healing time after laser resurfacing. Aesthetic Plastic Surgery 36: 431-437, 2012.
Henemyre-Harris, C. L., Adkins, A. L., Chuang, A. H., et al. Addition of epidermal growth factor improves the rate
of sulfur mustard wound healing in an in vitro model. Eplasty 8: e16, 2008.
Marti, G. P., Mohebi, P., Liu, L., et al. KGF-1 for wound healing in animal models. Methods in Molecular Biology
423: 383-391, 2008.
Galiano, R. D., Tepper, O. M., Pelo, C. R., et al. Topical vascular endothelial growth factor accelerates diabetic
wound healing through increased angiogenesis and by mobilizing and recruiting bone marrow-derived cells.
The American Journal of Pathology 164: 1935-1947, 2004.
Saaristo, A., Tammela, T., Farkkila, A., et al. Vascular endothelial growth factor-C accelerates diabetic wound healing. The American Journal of Pathology 169: 1080-1087, 2006.
Kellar, R. S., Hubka, M., Rheins, L. A., et al. Hypoxic conditioned culture medium from fibroblasts grown under
embryonic-like conditions supports healing following post-laser resurfacing. Journal of Cosmetic Dermatology
8: 190-196, 2009.
Erlbaum, E., Fredenberg, M. The clinical anti-aging effects of ReGenica: A randomized double-blind placebo
controlled comparative trial. Data on File, Histogen, Inc., San Diego, CA. San Diego, CA: Histogen, Inc., 2008.
4
3
In this clinical trial, ReGenica Overnight Repair and ReGenica Day Repair SPF 15, formulations containing human
cell-conditioned media, applied daily during the 90 day study, resulted in highly statistically significant improvements in skin tactile roughness, texture, wrinkles, blotchiness, skin tone evenness, radiance and translucency as
measured by investigator assessments and supported by subjects’ self-assessments. Improvements noted by both
the investigator and subjects were noted rapidly (by 2 weeks), rose significantly to almost the full benefit by 4
weeks, and reached a high level by 12 weeks (end-of-study). ReGenica may provide significant benefit to consumers
seeking non-invasive measures to mitigate the effect of aging.
1.
4.
5.
6.
7.
8.
9.
10.
11.
12.
Chung, J., Cho, S., Kang, S. Why does the skin age? Intrinsic againg, photoaging, and their pathophysiology. In
D. S. Rigel, R. A. Weiss, H. W. Lim, et al. (Eds.), Photoaging, 1st Ed. New York: Marcel Dekker, Inc., 2004. Pp. 1-13.
Gilchrest, B. A. Photoaging. The Journal of Investigative Dermatology 133: E2-6, 2013.
Kligman, A. M. Early destructive effect of sunlight on human skin. JAMA: The Journal of the American Medical
Association 210: 2377-2380, 1969.
2012 Plastic Surgery Statistics Reports. American Society of Plastic Surgeons.
Adzick, N. S., Lorenz, H. P. Cells, matrix, growth factors, and the surgeon. The biology of scarless fetal wound
repair. Annals of Surgery 220: 10-18, 1994.
Zimber, M. P., Mansbridge, J. N., Taylor, M., et al. Human cell-conditioned media produced under embryonic-like
conditions result in improved healing time after laser resurfacing. Aesthetic Plastic Surgery 36: 431-437, 2012.
Henemyre-Harris, C. L., Adkins, A. L., Chuang, A. H., et al. Addition of epidermal growth factor improves the rate
of sulfur mustard wound healing in an in vitro model. Eplasty 8: e16, 2008.
Marti, G. P., Mohebi, P., Liu, L., et al. KGF-1 for wound healing in animal models. Methods in Molecular Biology
423: 383-391, 2008.
Galiano, R. D., Tepper, O. M., Pelo, C. R., et al. Topical vascular endothelial growth factor accelerates diabetic
wound healing through increased angiogenesis and by mobilizing and recruiting bone marrow-derived cells.
The American Journal of Pathology 164: 1935-1947, 2004.
Saaristo, A., Tammela, T., Farkkila, A., et al. Vascular endothelial growth factor-C accelerates diabetic wound healing. The American Journal of Pathology 169: 1080-1087, 2006.
Kellar, R. S., Hubka, M., Rheins, L. A., et al. Hypoxic conditioned culture medium from fibroblasts grown under
embryonic-like conditions supports healing following post-laser resurfacing. Journal of Cosmetic Dermatology
8: 190-196, 2009.
Erlbaum, E., Fredenberg, M. The clinical anti-aging effects of ReGenica: A randomized double-blind placebo
controlled comparative trial. Data on File, Histogen, Inc., San Diego, CA. San Diego, CA: Histogen, Inc., 2008.
4
REGENICA ANTI-AGING PROOF OF CONCEPT STUDY: RESULTS AND SUMMARY
REGENICA ANTI-AGING PROOF OF CONCEPT STUDY: RESULTS AND SUMMARY
Figure 1
Figure 1
Figures and Tables
Improvements from Baseline in Investigator Assessments
Figures and Tables
Improvements from Baseline in Investigator Assessments
*Statistically significant
improvement from baseline (p < .05)
*Statistically significant improvement from baseline.
*Statistically significant
improvement from baseline (p < .05)
*Statistically significant improvement from baseline.
5
6
5
Table 1
Average Investigator Assessment Scores Changes and Percent Improvement
from Visit 1 for Each Assessment Category
Mean (95% CI)
Average Assessment Score Changes
Category
Visit 2 (N=21)
Tactile Roughness
-0.24 (-0.44, -0.04)
Visual Texture
-0.19 (-0.37, -0.01)
Wrinkles
-0.19 (-0.37, -0.01)
Blotchiness
-0.19 (-0.37, -0.01)
Skin Tone
Radiance
Translucency
0.1 (-0.04, 0.23)
0.14 (-0.02, 0.31)
0.1 (-0.1, 0.29)
Percent Improvement From Baseline
Tactile Roughness
12.82 (2.15, 23.66)
Visual Texture
8.33 (0.43, 16.16)
Wrinkles
7.14 (0.37, 13.86)
Blotchiness
8.16 (0.43, 15.88)
Skin Tone
Radiance
Translucency
5.88 (-2.47, 14.20)
9.38 (-1.32, 20.39)
5.41 (-5.68, 16.48)
Table 1
Average Investigator Assessment Scores Changes and Percent Improvement
from Visit 1 for Each Assessment Category
Mean (95% CI)
Visit 3 (n=19)
-0.74 (-1.01, -0.47)
-0.47 (-0.77, -0.18)
-0.32 (-0.6, -0.04)
-0.32 (-0.6, -0.04)
Visit 4 (n=17)
-0.82 (-1.03, -0.62)
-0.71 (-1.06, -0.35)
-0.35 (-0.66, -0.04)
-0.65 (-1.01, -0.29)
Visit 5 (n=18)
-0.83 (-1.09, -0.58)
-1.06 (-1.37, -0.74)
-0.78 (-1.05, -0.51)
-1 (-1.45, -0.55)
Average Assessment Score Changes
Category
Visit 2 (N=21)
Tactile Roughness
-0.24 (-0.44, -0.04)
Visual Texture
-0.19 (-0.37, -0.01)
Wrinkles
-0.19 (-0.37, -0.01)
Blotchiness
-0.19 (-0.37, -0.01)
0.42 (0.13, 0.71)
0.53 (0.19, 0.86)
0.32 (0.04, 0.6)
0.59 (0.27, 0.91)
0.94 (0.44, 1.44)
0.71 (0.35, 1.06)
1.06 (0.62, 1.49)
1.39 (0.97, 1.81)
1.11 (0.73, 1.49)
Skin Tone
Radiance
Translucency
39.68 (25.27, 54.30)
20.72 (7.68, 33.62)
11.84 (1.50, 22.47)
13.53 (1.72, 25.75)
44.34 (33.33, 55.38)
30.88 (15.28, 46.29)
13.24 (1.50, 24.72)
27.73 (12.45, 43.35)
44.87 (31.18, 58.60)
46.18 (32.31, 59.83)
29.17 (19.10, 56.18)
42.86 (23.61, 62.23)
Percent Improvement From Baseline
Tactile Roughness
12.82 (2.15, 23.66)
Visual Texture
8.33 (0.43, 16.16)
Wrinkles
7.14 (0.37, 13.86)
Blotchiness
8.16 (0.43, 15.88)
26.01 (8.02, 43.83)
34.54 (12.5, 56.58)
17.92 (2.27, 34.09)
36.33 (16.67, 56.17)
61.76 (28.95, 94.74)
40.06 (19.89, 60.23)
65.20 (38.27, 91.98)
91.15 (63.82, 119.8)
63.06 (41.48, 84.66)
Skin Tone
Radiance
Translucency
0.1 (-0.04, 0.23)
0.14 (-0.02, 0.31)
0.1 (-0.1, 0.29)
5.88 (-2.47, 14.20)
9.38 (-1.32, 20.39)
5.41 (-5.68, 16.48)
Visit 3 (n=19)
-0.74 (-1.01, -0.47)
-0.47 (-0.77, -0.18)
-0.32 (-0.6, -0.04)
-0.32 (-0.6, -0.04)
Visit 4 (n=17)
-0.82 (-1.03, -0.62)
-0.71 (-1.06, -0.35)
-0.35 (-0.66, -0.04)
-0.65 (-1.01, -0.29)
Visit 5 (n=18)
-0.83 (-1.09, -0.58)
-1.06 (-1.37, -0.74)
-0.78 (-1.05, -0.51)
-1 (-1.45, -0.55)
0.42 (0.13, 0.71)
0.53 (0.19, 0.86)
0.32 (0.04, 0.6)
0.59 (0.27, 0.91)
0.94 (0.44, 1.44)
0.71 (0.35, 1.06)
1.06 (0.62, 1.49)
1.39 (0.97, 1.81)
1.11 (0.73, 1.49)
39.68 (25.27, 54.30)
20.72 (7.68, 33.62)
11.84 (1.50, 22.47)
13.53 (1.72, 25.75)
44.34 (33.33, 55.38)
30.88 (15.28, 46.29)
13.24 (1.50, 24.72)
27.73 (12.45, 43.35)
44.87 (31.18, 58.60)
46.18 (32.31, 59.83)
29.17 (19.10, 56.18)
42.86 (23.61, 62.23)
26.01 (8.02, 43.83)
34.54 (12.5, 56.58)
17.92 (2.27, 34.09)
36.33 (16.67, 56.17)
61.76 (28.95, 94.74)
40.06 (19.89, 60.23)
65.20 (38.27, 91.98)
91.15 (63.82, 119.8)
63.06 (41.48, 84.66)
Note: Bolded mean (CI) indicates statistically significant improvement
Note: Bolded mean (CI) indicates statistically significant improvement
Table 2
Table 2
Percent of Subjects Who Agreed Somewhat or Strongly Agreed with Assessment
Statements at Each Visit
Statement
Time Post-Baseline (Weeks)
2
4
8
76.2
89.5
94.1
57.1
84.2
82.4
76.2
78.9
88.2
61.9
84.2
88.2
71.4
84.2
76.5
76.2
89.5
82.4
71.4
89.5
94.1
71.4
78.9
76.5
66.7
78.9
88.2
76.2
94.7
76.5
61.9
78.9
88.2
61.9
73.7
82.4
81.0
89.5
94.1
76.2
94.7
76.5
81.0
94.7
82.4
52.4
68.4
88.2
76.2
89.5
94.1
69.7
85.1
85.5
8.41
7.95
6.62
I am satisfied with the overall results this product provides
My lines and wrinkles are less visible
My face appears firm
My skin tone has become more even
My skin brightness has increased
My skin texture has improved
My skin looks refreshed
My skin feels more resilient
My skin clarity has improved
My face feels rejuvenated
My skin has a youthful glow/radiance
My skin feels more firm
My skin looks and feels more hydrated
My skin looks more healthy
My skin feels more balanced
My pores appear less visible
My skin feels soothed
Mean
SD
6
5
Percent of Subjects Who Agreed Somewhat or Strongly Agreed with Assessment
Statements at Each Visit
Statement
12
94.4
94.4
94.4
94.4
100.0
94.4
100.0
88.9
94.4
83.3
94.4
94.4
94.4
100.0
88.9
83.3
94.4
93.5
4.90
I am satisfied with the overall results this product provides
My lines and wrinkles are less visible
My face appears firm
My skin tone has become more even
My skin brightness has increased
My skin texture has improved
My skin looks refreshed
My skin feels more resilient
My skin clarity has improved
My face feels rejuvenated
My skin has a youthful glow/radiance
My skin feels more firm
My skin looks and feels more hydrated
My skin looks more healthy
My skin feels more balanced
My pores appear less visible
My skin feels soothed
Mean
SD
6
Time Post-Baseline (Weeks)
2
4
8
76.2
89.5
94.1
57.1
84.2
82.4
76.2
78.9
88.2
61.9
84.2
88.2
71.4
84.2
76.5
76.2
89.5
82.4
71.4
89.5
94.1
71.4
78.9
76.5
66.7
78.9
88.2
76.2
94.7
76.5
61.9
78.9
88.2
61.9
73.7
82.4
81.0
89.5
94.1
76.2
94.7
76.5
81.0
94.7
82.4
52.4
68.4
88.2
76.2
89.5
94.1
69.7
85.1
85.5
8.41
7.95
6.62
12
94.4
94.4
94.4
94.4
100.0
94.4
100.0
88.9
94.4
83.3
94.4
94.4
94.4
100.0
88.9
83.3
94.4
93.5
4.90
Figure 2A
Percent of Subjects Who Agreed Somewhat or Strongly Agreed with
Assessment Statements at 2 Weeks and 12 Weeks After Initiating Treatments
7
Figure 2A
Percent of Subjects Who Agreed Somewhat or Strongly Agreed with
Assessment Statements at 2 Weeks and 12 Weeks After Initiating Treatments
8
7
Figure 2B
Percent of Subjects Who Agreed Somewhat or Strongly Agreed with
Assessment Statements at 2 Weeks and 12 Weeks After Initiating Treatments
*See Table 2 for complete subject assessment statements
8
7
Figure 2B
Percent of Subjects Who Agreed Somewhat or Strongly Agreed with
Assessment Statements at 2 Weeks and 12 Weeks After Initiating Treatments
*See Table 2 for complete subject assessment statements
8
Table 3
Overall Subjects Satisfaction: % of Subjects by Visit
Visit 2
81%
71%
100%
100%
95%
Would you recommend this product to a friend?
Would you want to purchase this product if available?
Were you satisfied with the product’s texture?
Were you satisfied with the product’s color?
Were you satisfied with the product’s smell?
Figure 3
Visit 3
95%
89%
100%
100%
95%
Table 3
Visit 4
100%
94%
94%
100%
94%
Visit 5
100%
100%
100%
100%
100%
Representative Photographs Taken at Baseline, 14 and 30 Days After Initiating Treatments
A. Left Oblique Picture taken at Baseline and Day 14. Reduced blotchiness as well as smoother texture and more
even skin tone are seen at 14 days in these left oblique views.
Baseline
14 Days
B. Left Oblique pictures taken at Baseline and Day 14. Note the reduction of wrinkles in the upper and lateral
cheek area.
Baseline
14 Days
9
Overall Subjects Satisfaction: % of Subjects by Visit
Visit 2
81%
71%
100%
100%
95%
Would you recommend this product to a friend?
Would you want to purchase this product if available?
Were you satisfied with the product’s texture?
Were you satisfied with the product’s color?
Were you satisfied with the product’s smell?
Figure 3
Visit 3
95%
89%
100%
100%
95%
Visit 4
100%
94%
94%
100%
94%
Visit 5
100%
100%
100%
100%
100%
Representative Photographs Taken at Baseline, 14 and 30 Days After Initiating Treatments
A. Left Oblique Picture taken at Baseline and Day 14. Reduced blotchiness as well as smoother texture and more
even skin tone are seen at 14 days in these left oblique views.
Baseline
14 Days
B. Left Oblique pictures taken at Baseline and Day 14. Note the reduction of wrinkles in the upper and lateral
cheek area.
Baseline
14 Days
10
9
C. Frontal picture taken at Day 30. Note the improved texture, radiance and skin tone at Day 30 compared to
baseline.
Baseline
30 Days
D. Left oblique picture taken at Day 30. Reduced wrinkles, smoother skin texture, reduced blotchiness and
better skin tone and radiance are seen on Day 30 compared to Baseline.
Baseline
30 Days
10
9
C. Frontal picture taken at Day 30. Note the improved texture, radiance and skin tone at Day 30 compared to
baseline.
Baseline
30 Days
D. Left oblique picture taken at Day 30. Reduced wrinkles, smoother skin texture, reduced blotchiness and
better skin tone and radiance are seen on Day 30 compared to Baseline.
Baseline
30 Days
10
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