A new octenidine emollient cream (LAS41010)
offers good skin tolerability in healthy subjects,
and improves skin barrier function and hydration
in adults with atopic dermatitis
Wigger-Alberti W (bioskin GmbH, Hamburg, Germany),
von der Weth R, Willers C , Havlickova B (Almirall R&D, Reinbek,
Germany), Pau-Charles I (Hospital Clínic, Barcelona, Spain)
A new octenidine emollient cream (LAS41010) offers good skin tolerability in healthy subjects,
and improves skin barrier function and hydration in adults with atopic dermatitis
Wigger-Alberti W (bioskin GmbH, Hamburg, Germany), von der Weth R, Willers C, Havlickova B
(Almirall R&D, Reinbek, Germany), Pau-Charles I (Hospital Clínic, Barcelona, Spain)
Emollients are a mainstay treatment in atopic dermatitis (AD) improving skin barrier
function, skin dryness and discomfort1
S.aureus skin colonization is thought to play a role in AD development and
perpetuation in predisposed individuals. Antiseptics can prevent bacterial skin
colonization and secondary infection of dermatitis, but their use is often limited by
their irritant properties2
The antiseptic octenidine dihydrochloride has a broad spectrum of antimicrobial
activity against gram positive and gram negative bacteria (including MRSA), fungi and
enveloped viruses. Strong binding to bacterial cell membranes provides high
antimicrobial efficacy without affecting human epithelia or wound tissue3. It is also
active against biofilm-producing S.aureus, including MRSA4, which have been
described to be frequently present and pathogenically relevant in AD patients5
We aim to present the results of two studies assessing the skin tolerability and, on the
other hand, the effects on the skin barrier function and hydration after application of
a new octenidine 0.25% emollient cream formulation (LAS41010).
In the first skin tolerability study, LAS41010 emollient cream containing
octenidine 0.25%, as well as the active ingredient-free cream vehicle, a
positive control (2% SDS) and a negative control (white paraffin wax) were
applied semi-occlusively on the back of 33 healthy adults once daily for 21
days
The test areas were clinically assessed for local irritation by independent
investigator blinded to the treatment allocation on study days 2-6, 8-13, 1520 and day 22. Each test field was scored for erythema on a visual scale
(VAS) 0-4. From this score, the primary endpoints of mean erythema score
and cumulative irritation score (CIS) were calculated. Subjects were
monitored for adverse events throughout the study and a physical
examination was carried out at baseline and end-of-study
Differences between the treatments were tested by exact Wilcoxon-Signed
Rank test at level α=0.05, p-values were interpreted descriptively
LAS41010 did not cause significant irritation. Only mild diffuse erythema
(VAS grade 1) was observed in 2 subjects receiving LAS41010 and 2 subjects
receiving the active ingredient-free vehicle cream. No reactions to the
negative control were observed, while the positive control (2%SDS) showed
irritancy potential (Fig.1).
No statistically significant differences
in CIS were observed between
LAS41010 and either the octenidinefree emollient vehicle or the negative
control. However, mean CIS was
significantly lower in each of the
treatment fields compared to the
positive control (data not shown).
In the second study on physical skin parameters, 20 adults with AD (meeting
Hanifin and Rajka's criteria) without an active flare applied LAS41010 cream
and the octenidine-free emollient vehicle on a 300 cm2 test area on
separate limbs once daily, without occlusion, for 1 week.
Skin barrier function and hydration were assessed by investigators blinded
to the treatment allocation by measuring transepidermal water loss (TEWL)
and corneometry, respectively. The presence of erythema and dryness were
also assessed and scored using a VAS scale (0-4).
In the second study, baseline TEWL significantly declined by -14.7% following
the once-daily application of LAS41010 for one week, while the octenidinefree emollient vehicle achieved a non-significant -5,6% improvement (Fig.2).
Baseline skin hydration (measured by corneometry) significantly improved by
+60.9% following the once-daily application of LAS41010 for one week. In this
case, the octenidine-free emollient vehicle achieved a slightly lower
improvement of +56,1%, which was also significant compared to baseline
(Fig.3).
LAS41010 also improved baseline skin dryness by 80% (statistically significant)
and baseline erythema by 30% (Fig.4).
LAS41010 has a very good skin tolerability and does not induce a clinically relevant
irritation on adults with healthy skin, even after repeated semi-occlusive application.
This is in contrast with other commonly used antiseptics, which have a well-known
irritation potential
LAS41010 is an effective emollient, significantly improving both skin barrier function
(as measured by TEWL) and hydration (as measured by corneometry) in subjects with
atopic dermatitis after just one week of treatment with a once daily application
LAS41010 contains Octenidine, a well-tolerated broad spectrum antiseptic that is
highly effective against S.aureus, which frequently colonizes the skin of AD patients,
correlates with disease severity and may induce disease flare-ups and secondary skin
infections
The product was safe and very well tolerated throughout both studies, and found to
have a high degree of cosmetic acceptance among subjects with atopic dermatitis
(data not shown)
Acknowledgement: This study was supported by Almirall S.A., Barcelona, Spain
1. Ring J et al. Guidelines for treatment of atopic eczema (atopic dermatitis) Part II. J Eur Acad Dermatol Venereol. 2012;26:1176-1193
2. Lachapelle JM "A comparison of the irritant and allergenic properties of antiseptics". Eur J Dermatol. 2014;24:3-9
3. Hübner N. "Octenidine dihydrochloride, a modern antiseptic for skin, mucous membranes and wounds". Skin Pharmacol Physiol 2010; 23:244-258
4. Amalaradjou MA, Venkitanarayanan K. Antibiofilm effect of Octenidine Hydrochloride on Staphylococcus aureus, MRSA and VRSA. Pathogens 2014;3:404-416
5. Allen HB et al. The presence ad impact of biofilm-producing staphylococci in atopic dermatitis. JAMA Dermatol. 2014;150:260-265