Effects of calcipotriol on stratum corneum barrier function, hydration and cell renewal in humans

Summary Calcipotriol. a vitamin D analogue utilized for psoriasis, has irritation as its most frequent reported adverse event. However, studies on its irritant properties in humans have produced conflicting data. This study evaluates the effect of calcipotriol on stratum corneum barrier function, hydration and cell turnover in healthy volunteers, compared with sodium lauryl sulphate (SLS) as a model irritant. Calcipotriol 0·005% ointment and 1% aqueous SLS solution were applied for 2 weeks (5 consecutive days weekly) on untreated and on dansyl-chloride-labelled skin. Irritant responses were documented by visual scoring and by measurement of the transepidermal water loss (TEWL) and stratum corneum hydration (electrical capacitance), until day 18 Stratum corneum turnover time (SCTT) was the time in days between staining (day 0) and the disappearance of dansyl fluorescence. SLS caused more erythema, scaling, and a significant TEWL increase for 18 days. In contrast, calcipotriol induced erythema, and slightly but significantly increased TEWL on day 11 only, as compared with the vehicle control (P<0·05) SLS, but not calcipotriol, caused skin dryness from day 4 to day 18. The shortest SCTT was obtained at SLS-exposed sites (11·2 ± 0·7 days: mean± SD). Calcipotriol significantly shortened SCTT (16.3 ± 1.1 days) when compared with its vehicle. Compared with the skin irritation induced by SLS, under these test conditions, calcipotriol is a far weaker irritant on normal human skin. In addition, calcipotriol accelerates stratum corneum turnover to a significantly greater extent than its vehicle.     

Long-term repetitive sodium lauryl sulfate-induced irritation of the skin: an in vivo study

Skin may adapt to topical irritants through accommodation. This study focuses on long-term exposure to irritants and attempts to demonstrate accommodation. Sodium lauryl sulfate (SLS) induced irritant contact dermatitis at 3 concentrations (0.025% to 0.075%). Distilled water, acetone and an empty chamber served as controls. Experimental compounds were applied to forearms of 7 healthy volunteers for 24 hr before replacing by a fresh chamber for 6 non-consecutive weeks over 103 days. Possible accommodation was quantified by visual scoring (erythema and dryness) and by bioengineering parameters: transepidermal water loss (TEWL), capacitance, chromametry and laser Doppler flowmetry (LDF). Significant erythema, dryness, elevated TEWL, skin colour reflectance and LDF values occurred during the exposure periods. Upon repeat exposure, an immediate and augmented response in erythema, TEWL, skin colour reflectance and LDF developed. However, irritant skin changes were not sustained. Irritation parameters return to baseline after cessation of exposure. There was no evidence of sustained irritation or accommodation after the last exposure. Study findings do not document sustained accommodation or adaptive hyposensitivity after long-term repetitive irritant exposure under these test conditions. Alternative models should be developed to prove or disprove the accommodation hypothesis.     

Barrier recovery and influence of irritant stimuli in skin treated with a moisturizing cream

Moisturizers are used daily by many people to alleviate symptoms of clinically and subjectively dry skin. Recent studies suggest that certain ingredients in creams may accelerate the recovery of a disrupted barrier and decrease the skin susceptibility to irritant stimuli. In the present single-blind study, a moisturizing cream was tested for its influence both on barrier recovery in surfuctant-damaged skin and on the susceptibility of normal skin to exposure to the irritant sodium lauryl sulphate (SLS). Parameters measured were transepidermal water loss (TEWL) and skin corneometer values, indicating degree of hydration. Treatment of surfactant-damaged skin with the test cream for 14 days promoted barrier recovery, as observed as a decrease in TEWL. Skin corneometer values also normalized more rapidly during the treatment. In normal skin, use or the test cream significantly reduced TFWL after 14 days of treatment, and irritant reactions to SLS were, significantly decreased. Skin corneometer values increased after only 1 application and remained elevated after 14 days. In conclusion, the accelerated rate of recovery of surfactant-damaged skin and the lower degree of SLS-induced irritation in normal skin treated with the test cream may be of clinical relevance in attempts to reduce contact dermatitis due to irritant stimuli.     

Effect of an antioxidant (quercetin) on sodium-lauryl-sulfate-induced skin irritation

Quercetin is a bioflavonoid with antioxidant and anti-inflammatory activity. The purpose of this study was to examine the effect of quercetin on acute skin irritation, with special interest in the skin barrier function recovery. Acute irritant contact dermatitis was induced in 15 patients by 24-h occlusion of 2% sodium lauryl sulfate (SLS) (day (D) 1). The influence of application on SLS-irritated skin of topical quercetin for 5 consecutive Ds, compared to vehicle and controls, was studied. Parameters measured were transepidermal water loss (TEWL) and erythema index. Final measurements were taken on D 7 after a 1-D rest period. TEWL and the erythema index continued to rise 2 D after application of SLS and 1 D after treatment with quercetin, vehicle or controls. Both TEWL and erythema values at D 7 did not return to values before the SLS barrier disruption at all the test sites. Therefore, quercetin topically applied after induction of irritant contact dermatitis does not appear to increase the recovery of barrier function and erythema caused by SLS.     

Tacrolimus enhances irritation in a 5-day human irritancy in vivo model

Tacrolimus (FK 506) is a macrolide discovered in 1984 as a metabolic product of Streptomyces tsukabaensis. It has been used successfully in treating atopic dermatitis, allergic contact dermatitis, lichen planus mucosae and pyoderma gangrenosum. In the present study, we evaluated the anti-inflammatory activity of FK 506 in 2 human skin inflammation models. FK 506 as Protopic(R) cream was tested (i) in a 4-day repetitive irritation test with 2 x daily application of sodium lauryl sulphate (SLS), and (ii) in a UVB erythema model. The effect was evaluated visually and quantified by non-invasive bioengineering methods, namely chromametry and tewametry (TEWL). When FK 506 was applied 30 min after SLS irritation, an increased inflammation in comparison to controls was observed with all 3 methods, with only the TEWL data reaching statistical significance. 1 x daily application of FK 506 for 5 days, starting at the end of the 4-day irritation period, was without any effect. Similarly, no effect of FK 506 was seen in the UVB model. In conclusion, FK 506 was shown to enhance experimentally induced irritant contact dermatitis and not to accelerate healing of irritant contact dermatitis and UVB erythema.     

Anti-inflammatory effect of pimecrolimus in the sodium lauryl sulphate test

Background Pimecrolimus is a calcineurin inhibitor used for the topical treatment of inflammatory skin diseases. We have shown previously that pimecrolimus cream is not effective on intact skin in the ultraviolet erythema test. Objective To test the anti‐inflammatory effect of pimecrolimus cream after damage of the skin barrier by sodium lauryl sulphate (SLS) in a randomised, placebo‐controlled, observer‐blinded study. Methods SLS (3% v/v) was applied under occlusion on the back of 36 healthy volunteers for 24 h. Subsequently, the test areas were treated for 24 h with pimecrolimus cream, 1% hydrocortisone in a hydrophilic ointment, and the vehicle alone over three consecutive days. One control area remained untreated. The erythema index and the transepidermal water loss (TEWL) served as readout parameters to assess the SLS‐induced skin irritation. Results Pimecrolimus cream and 1% hydrocortisone cream significantly reduced the SLS‐induced erythema. The two test preparations did not have a significant effect on the TEWL. Conclusion After damage to the skin barrier by SLS, pimecrolimus seems to penetrate into the skin as shown by a reduction of the irritation‐induced erythma. These data further support the notion that pimecrolimus is selectively effective in the treatment of skin disorders with an impaired function of the epidermal barrier.     

Effects of calcipotriol cream and ointment, clobetasol cream and ointment and tretinoin cream on the erythemogenicity of UVB

Various studies have shown the blocking effects of topical agents on UVB penetration, which can be used in combination with phototherapy. In this study, the photoprotective effects of 0.005% calcipotriol, 0.05% clobetasol-17-propionate, and 0.1% tretinoin, which can be used in combination with broad-band UVB, were investigated in an in vivo test. In a study group of 20 patients, phototests were performed to determine minimal erythema doses (MED) and the tests were repeated with thin (0.1 cc/25 cm2) and thick (0.3 cc/25 cm2) calcipotriol, clobetasol-17-propionate, and tretinoin in cream forms and sunscreen. After determining the MED, the test was repeated in another 20 patients with thin and thick calcipotriol and clobetasol-17-propionate in both cream and ointment forms and sunscreen. MED was increased with thin and thick applications of all agents. Moreover, the photoprotective effects of each agent increased with their thick applications compared with thin ones. The application of calcipotriol cream and ointment, clobetasol cream and ointment, and tretinoin cream, all of which can block UVB, is not recommended just before phototherapy.     

Potential for irritation increases from the wrist to the cubital fossa

The effect of site on the irritant dermatitis potential was studied in 10 subjects using the volar surface of the forearm. Erythema scoring and transepidermal water loss (TEWL) measurements were used to assess irritation at different levels on the forearm. A sodium lauryl sulphate (SLS 2 g/v%) solution was used as a standard irritant in a patch test procedure and on open tests. Both the erythema scores and measurements of the TEWL of exposed skin showed significant localization differences, and demonstrated that the same sites on the forearm should be used for irritancy tests and possibly physiological studies.     

Effect of a lipid-rich emollient containing ceramide 3 in experimentally induced skin barrier dysfunction

In the present study we compared the effect of a ceramide 3-containing emollient (Locobase(R) Repair) with a control emollient (vaselinum album/cremor lanette ana) and untreated damaged skin using clinical, bioengineering and immunohistochemical methods in two different models of experimentally induced skin barrier dysfunction. In model A (n = 13) skin barrier dysfunction was inflicted at three investigation sites by tape stripping. In model B (n = 13) the volunteers were patch tested at three investigation sites with sodium dodecyl sulphate (0.2%) for 4 h a day for 4 consecutive days. The investigation sites were treated once a day with the above-mentioned agents. Irritant reaction was assessed daily by erythema scoring and measurements of transepidermal water loss (TEWL). After 5D, punch biopsies were taken from all sites. Immunohistochemical assessment was carried out with respect to epidermal proliferation, epidermal differentiation and Langerhans cells. Tape stripping resulted in an erythematous reaction and an increase of TEWL associated with up-regulation of cycling cells, involucrin and expression of cytokeratin 16. At day 4, ceramide 3-containing emollient significantly decreased (p < 0.03) the erythema score, TEWL and cycling cells in comparison with the untreated site. Repetitive exposure to SDS induced a variable degree of erythema, gradual increase of TEWL, an increase of cycling cells, and up-regulation of involucrin, E-FABP and SKALP. The treatment with the control emollient significantly prevented erythema, increase of TEWL and cycling cells at day 4 compared to the untreated site. In summary, the present study demonstrated that both tested emollients improve skin barrier in different conditions compared to the untreated skin. There is some indication that formulations containing skin-related lipids might be of benefit in barrier disruption following tape stripping. Different models and clinical trials are needed to establish the usefulness in specific conditions of emollients containing skin-related lipids.     

Topical D-vitamins: multiparametric comparison of the irritant potential of calcipotriol, tacalcitol and calcitriol in a hairless guinea pig model

The irritant potential of calcipotriol. 1α.24-diliydroxy vitamin D₃, (tacalcitol) and 1α, 25-dihyd rosy-vitamin- D₃ (calcitriol) was compared in a hairless guinea pig model. Randomized, occlusive patch testing for 2 days was used. Each group of X animals was tested simultaneously with the 3 substances and a placebo vehicle. 3 dose levels i.e. 500 μg/ml, 50 μg/ml and 5 μg/ml were used, Test sites were evaluated at day 2 (2 h after removal of the patches) and again at day 3. Evaluation was blinded and based on a multiple parameter assessment of skin irritancy. comparing clinical scoring. skin perfusion using high resolution laser Doppler image scanning, skin colour (a*, Minolta ChromaMeter) and skin thickening (20 MHz ultrasound) indicating oedema. Skin biopsies were taken for histological preparation and assessment of epidermal hyperplasia. No difference was observed between the irritant potential of calcipotriol, tacalcitol and calcitriol bused on clinical scoring as well as objective non-invasive measuring techniques. All 3 substances showed a dose-dependent and equal increase in clinical irritation score. cutaneous blood flow, skin colour and epidermal hyperplasia. The cutaneous inflammatory reaction was dominated by vasodilation and increased cutaneous perfusion. Oedema formation was only seen ill the highest dosages tested. Skin barrier damage was not induced as TEWL remained unaffected. The hairless guinea pig appears a valid model to test irritancy of topical D-vitamins since the same profile of irritancy was previously established in humans for 2 of the compounds tested. calcitriol and calcipotriol.     

The hairless guinea-pig as a model for treatment of cumulative irritation in humans

BACKGROUND: The effect of six skin-care formulations (SCFs) on experimentally induced cumulative irritation was studied in hairless guinea-pigs (HLGPs) and in human volunteers (HVs). The formulations were a basic cream, a carbomer cream and four modifications of the carbomer cream, containing either 10% isopropyl palmitate (IPP cream), 10% glycerol (glycerol cream), 19.5% canola oil (canola oil cream) or 0.5% (-)-alpha-bisabolol (bisabolol cream). METHODS: In HLGP, irritant dermatitis was induced with 30 min daily exposure for 4 days to 0.5% sodium lauryl sulfate aq. (SLS). In HVs, irritant dermatitis was induced with 10 min daily exposure for 5+4 days (no irritation on weekends) to 3% SLS aq. on the right and 30% nonanoic acid (NON) in n-propanol on the left volar forearm. Clinical scoring was performed daily; evaporimetry (total epidermal water loss (TEWL)), hydration and colorimetry were measured at baseline (day 0) in the middle and at the end of treatment. Treatments were applied twice daily. The basic cream and the IPP cream were excluded from testing in HLGP because they were known from previous studies to be irritant in HLGP, while all formulations were known to be equally and well tolerated locally in humans. RESULTS: All formulations worsened the skin irritation in HLGP: the glycerol cream the least, the canola oil cream the most, while the bisabolol cream and the carbomer cream were indistinguishable. In humans, the glycerol cream was better than 'No Treatment' after cumulative irritation with both SLS and NON. The basic cream was better tolerated in humans than was expected from previous testing in HLGPs. CONCLUSION: In conclusion, the results from the studies in HLGPs and HVs are in agreement with regard to ranking of the SCFs. Further, the glycerol cream showed a positive treatment effect on both SLS- and NON-irritated skin in HVs.     

Efficacy of topical corticosteroids on irritant skin reactions

Topical corticosteroids are frequently used in the treatment of irritant contact dermatitis (ICD). The efficacy of this treatment has, however, not been thoroughly established, and experimental studies on the topic have provided conflicting results. The aim of the present study was to evaluate the effect of potent topical corticosteroids on experimentally-induced irritant skin reactions in a double-blind, vehicle-controlled study. 16 healthy volunteers had sodium lauryl sulfate patch tests symmetrically applied to the upper arms. After removal of patch tests, a potent topical cortico-steroid (betamethasone-17-valerate) was applied to the irritant skin reaction on one arm, while the corresponding vehicle was applied to the irritant skin reaction on the opposite arm 2 × daily for 7 days. Reactions were evaluated by measurement of transepidermal water loss (TEWL) and erythema. After 7 days, statistically significant lower values of TEWL and erythema were found in corticosteroid-treated, compared to the vehicle-treated, skin reactions. The results indicate that topical corticosteroids improve healing of ICD.     

Placebo-controlled evaluation of the irritant potential of tacalcitol (1a,24-dihydroxyvitamin D3) in healthy volunteers

In the treatment of psoriasis with topical vitamin D3 analogues, lesional and perilesional irritation is the main side-effect. The aim of this study was to investigate whether local side-effects generated by tacalcitol, a vitamin D3 analogue, show concentration dependence. 3 different concentrations of tacalcitol (0.4; 4; 40 microg/g ointment) and the vehicle were applied on normal skin of the back of 25 healthy volunteers under occlusive conditions for 5 days. Assessment of erythema, infiltration and scaling as well as measurement of transepidermal water loss (TEWL) was performed on days 1 to 5. On day 5, additional skin barrier tests (DMSO test, alkali resistance test) were performed. Erythema and slight infiltration, but no scaling, were observed in a number of subjects without significant differences. TEWL also did not show significant differences for the test formulations, though there was a tendency towards lower values in the untreated areas. In the skin barrier tests, a tendency towards higher alkali resistance in the test areas treated with 40 microg tacalcitol/g ointment was detected. Thus, under occlusive conditions, the irritant potential of tacalcitol is very low. There is no convincing evidence of concentration dependence in irritation generated by tacalcitol when applied under occlusive conditions.     

Specific barrier response profiles after experimentally induced skin irritation in vivo

Background

Recently, natural moisturizing factors (NMFs) and corneocyte surface topography were suggested as biomarkers for irritant dermatitis.

Objectives

To investigate how exposure to different irritants influences corneocyte surface topography, NMF levels and the barrier function of human skin in vivo.

Methods

Eight healthy adult volunteers were exposed to aqueous solutions of 60% n‐propanol, 0.5% sodium lauryl sulfate (SLS), 0.15% sodium hydroxide, and 2.0% acetic acid, and distilled water, in a repeated irritation test over a period of 96 hours. Erythema, transepidermal water loss (TEWL), skin hydration, the dermal texture index (DTI) and NMF levels were measured at baseline, and after 24 and 96 hours.

Results

SLS and sodium hydroxide had the most pronounced effects on erythema and TEWL. Although n‐propanol caused only slight changes in TEWL and erythema, it showed pronounced effects on skin hydration, NMF levels, and the DTI. NMF was the only parameter that was significantly altered by all investigated irritants. The changes in the DTI were inversely associated with NMF levels and skin hydration.

Conclusion

Skin barrier impairment and the inflammatory response are irritant‐specific, emphasizing the need for a multiparametric approach to the study of skin irritation. NMF levels seem to be the most sensitive parameter in detecting irritant‐induced skin barrier alterations.     

Acute irritant contact dermatitis: recovery time in man

Our understanding of the details of the recovery time of acute irritant contact dermatitis (ICD) is limited. We examined skin reactivity to a model surfactant, sodium lauryl sulfate (SLS). on previous acute ICD and normal sites over time with visual grading and noninvasive instruments. Acute ICD was induced on the upper arms of 18 volunteers (aged 30 to 51 years) by occluded application of 1% SLS for 24 h. Previous ICD and normal sites were provoked by occluded application of 2% or 7.5% SLS 30 min daily 4 consecutive days. Skin reactivity was assessed daily by visual erythema scoring (VES), transepidermal water loss (TEWL), skin color reflectance (SCR) and electrical capacitance (EC). Skin function of previous ICD sites assessed, by VES, TEWL. SCR, and EC did not normalize until 2 weeks later: all parameters of previous ICD returned to normal after 3 weeks. While skin reactivity to 2% und 7.5% SLS showed no differences between previous ICD and normal sites at 4 weeks, differences of irritant reactivity especially 7,5% SLS between previous ICD and normal sites were significant at 3 weeks post-provocation. Our results demonstrate that irritation evaluated with irritant provocation was long-lasting, even though skin functional parameters assessed by various bioengineering instruments returned to normal. Complete recovery of skin function including irritability after acute ICD induced by 1% SLS was achieved approximately 4 weeks later. The date were generated with a model surfactant: it remains to be determined whether similar responses will be noted with chemicals of different physicochemical properties.     

Post-application occlusion substantially increases the irritant response of the skin to repeated short-term sodium lauryl sulfate (SLS) exposure

Occlusion often, but not always, enhances percutaneous absorption and thus may facilitate skin irritation. Quantitative data about the impact occlusivity may have on minimal irritant stimuli to which the skin is exposed in daily life, and which may lead to chronic irritant contact dermatitis, are however lacking. Irritant stimuli were administered by repeated application of sodium lauryl sulfate (SLS) in an open application procedure. After the open exposure, the skin was either left open or occluded with plastic. Skin irritancy was assessed by means of visual grading and by transepidermal water loss (TEWL) measurements. Post-exposure occlusive treatment markedly enhanced the irritant response. 5 consecutive daily applications produced more irritation, with or without occlusion, than alternate day application. Occlusion may be a relevant factor in the development of irritant contact dermatitis from certain chemicals.     

Improvement in skin barrier function in patients with atopic dermatitis after treatment with a moisturizing cream (Canoderm)

Patients with atopic skin show a defective barrier function both in rough and in clinically normal skin, with an increasing risk of developing contact dermatitis. Moisturizing creams are often used in the treatment of dry skin. The purpose of this study was to investigate the influence of treatment with a urea-containing moisturizer on the barrier properties of atopic skin. Fifteen patients with atopic dermatitis treated one of their forearms twice daily for 20 days with a moisturizing cream. Skin capacitance and transepidermal water loss (TEWL) were measured at the start of the study and after 10 and 20 days. On day 21 the skin was exposed to sodium lauryl sulphate (SLS) and on day 22 the irritant reaction was measured non-invasively. Skin capacitance was significantly increased by the treatment, indicating increased skin hydration. The water barrier function, as reflected by TEWL values, tended to improve (P = 0.07), and the skin susceptibility to SLS was significantly reduced, as measured by TEWL and superficial skin blood flow (P < 0.05). Thus, it seems that certain moisturizers could improve skin barrier function in atopics and reduce skin susceptibility to irritants. The mechanism and the clinical relevance need further investigation.     

Topical antioxidants protect the skin from chemical-induced irritation in the repetitive washing test: a placebo-controlled, double-blind study

Background. There is increasing evidence that reactive oxygen species play an important role in the development of both irritant and allergic contact dermatitis. Objectives. To assess the potential of topical antioxidants to prevent the development of experimentally induced irritant contact dermatitis. Methods. We evaluated the effect of a cream containing a combination of antioxidants on sodium lauryl sulfate-induced irritant contact dermatitis in the repetitive washing test. As readout parameters for skin barrier function and cutaneous inflammation stratum corneum hydration, cutaneous blood flow and transepidermal water loss were assessed in 25 volunteers with bioengineering methods. Results. In comparison with the cream base and a frequently used barrier cream, the antioxidant cream had high radical scavenging activity and effectively protected the skin from chemical-induced irritation. Conclusions. The superiority of the cream with antioxidants to the cream base suggests that reactive oxygen species, at least in part, play a role in the development of irritant contact dermatitis.     

Irritancy of the skin disinfectant n-propanol

Hand disinfection with short-chain aliphatic alcohols, so-called "rub-ins" is the method of choice for cross-infection prevention in health care environments, but their irritant potential is not well known. Skin tolerance is a major compliance factor, and a high proportion of health care workers suffer from low-grade irritant contact dermatitis. Therefore, assessment of the irritancy of the skin disinfectant n-propanol 60%, and comparative 100% and 0% solutions, was performed in the setting of experimental low-grade ICD. ICD was induced by overnight patch exposure to H2O, and to 0.3% sodium dodecyl sulfate (SDS), in 12 probands, followed by repeated open exposure to the test substances. Outcome variables were transepidermal water loss (TEWL), and skin surface capacitance. On skin sites pre-irritated by SDS, all n-propanol concentrations (100%, 60%, 0%) increased TEWL. However, a clear divergence appeared between pure n-propanol, and the lower concentrations. In contrast to pure n-propanol, n-propanol 60% and 0% had no significant effect on TEWL on H2O-pre-irritated skin sites. Capacitance of pre-irritated skin sites was increased by exposure to H2O-containing n-propanol solutions (60% and 0%). These results show a clear difference between the irritant potential of n-propanol 100% on one side, and n-propanol 60% and 0% on the other side. The level of pre-existent skin irritation is a pertinent factor in susceptibility to irritation, as the irritant potential of n-propanol 60%, the concentration used in daily practice, and n-propanol 0% (water) became significant only on detergent-irritated skin. Thus, preventive skin care may be a constructive approach in increasing tolerance of modern hand disinfection practices.     

FS03.6Efficacy of MAS063D (''Atopiclair'') in irritant contact dermatitis

Objective:  To determine the efficacy of a topical, MAS063D, in managing the clinical signs and symptoms of experimentally induced irritant contact dermatitis (ICD).
Methods:  Two patches of ICD were created using sodium lauryl sulfate (SLS) in 20 consenting volunteers. MAS063D was applied to one patch and a vehicle‐only control to the other. Measurements were taken at baseline, 24, 48 and 72 hours as follows: blood flow volume (BFV); skin color (a*); transepidermal water loss (TEWL); patient's view of itch and visual scoring. Results: The objective measurements of BFV, a* and TEWL all showed statistically significant benefits of MAS063D over the vehicle‐only control. BFV and a* were significantly better at all time points (p = 0.046, p = 0.045 respectively at 72 hours) and TEWL at 48 and 72 hours (p = 0.02 at 72 hours). MAS063D demonstrated benefit in the visual scoring of irritant contact dermatitis that was not statistically significant. Patient‐assessed itch was low at baseline; significant improvement was neither expected nor demonstrated although a small benefit of MAS063D over vehicle was seen in the mean values.
Conclusions:  BFV and a* are both good indicators of local erythema. TEWL is a good indicator of skin integrity. MAS063D therefore demonstrated statistically significant benefit over vehicle on three clinically meaningful outcomes of SLS‐induced ICD, and therefore may benefit irritant contact dermatitis.