Halobetasol Propionate Lotion, 0.05% Provides Superior Hydration Compared to Halobetasol Propionate Cream, 0.05% in a Double-Blinded Study of Occlusivity and Hydration.

BACKGROUND: This study measured skin hydration and occlusivity of two test products [halobetasol propionate lotion, 0.05% (HBP Lotion) and Ultravate® (halobetasol propionate) cream, 0.05% (HBP Cream)] at 2, 4, and 6 hours after application to skin test sites previously challenged by dry shaving, which was performed to compromise the integrity of the stratum corneum barrier. METHODS: Trans-epidermal water loss (TEWL), an indicator of skin barrier function, was measured using cyberDERM, inc. RG-1 evaporimeter. Skin hydration was evaluated using IBS SkiCon-200 conductance meter. Test products were applied bilaterally on dry-shaved sites on the volar forearm sites, according to a randomization scheme, with two test sites untreated to serve as "dry-shaved" controls. TEWL and conductance were measured at 2, 4, and 6 hours post-treatment. RESULTS: HBP Lotion displayed a significant increase in skin hydration at 2, 4, and 6 hours post-treatment compared to the baseline values and dry-shaved controls (each, P less than 0.001). However, HBP Cream produced statistically significant increased skin hydration only after 6 hours (P less than 0.05). HBP Lotion was significantly more effective than HBP Cream in increasing skin hydration at 2 and 4 hours post-treatment (each, P less than 0.001), and had a directional advantage (not statistically significant) at 6 hours. Neither test product had a significant occlusive effect as measured by TEWL at 2, 4, and 6 hours post-application. CONCLUSION: Both formulations of HBP (Lotion and Cream) contributed to skin moisturization, as measured by skin conductance. HBP Lotion produced a significantly more rapid onset and higher level of moisturization at 2 and 4 hours post-application compared to HBP Cream. The TEWL results indicate that neither HBP Lotion nor HBP Cream provided any significant occlusivity to the skin.

J Drugs Dermatol. 2017;16(2):140-144.

Randomized comparison of a silicone tape and a paper tape for gentleness in healthy children.

PURPOSE: To compare the relative gentleness of a silicone tape to a paper tape in healthy infants and children. DESIGN: A randomized, grader-blinded, comparative study. SUBJECTS AND SETTING: The sample group comprised 24 healthy infants and children 9.1 to 46.7 months of age (mean ± SEM, 34.0 ± 2.21). The study was conducted at a dermatological research facility (cyberDERM, Inc) located in Broomall, Pennsylvania. All volunteers were recruited from the surrounding community. METHODS: Tapes measuring 1 × 1.5 inches were randomly applied to the left and right intrascapular regions of the upper back. Tapes were removed in a standardized fashion after 24 hours. The primary study outcome, gentleness, was based on visual assessments of skin damage, discomfort, and quantification of keratin removal. Four-point scales were used to assess skin damage, and a 10-point Faces, Legs, Activity, Cry, and Consolability instrument was used to assess discomfort. Secondary assessments included hair removal, tape edge-lift assessments, and parent preference for either tape. RESULTS: There was a significantly lower mean ± SEM erythema response for the silicone tape (0.93 ± 0.14 vs 1.35 ± 0.11, P = .0129) than for the paper tape. No measurable epidermal stripping occurred with the silicone tape compared to a mean ± SEM response of 0.29 ± 0.11 for the paper tape (P = .0039). Discomfort was significantly lower (P = .0002) for the silicone tape as compared to the paper tape (Faces, Legs, Activity, Cry, and Consolability score mean difference from baseline 0.5 vs 3.3, P = .0002). Keratin removal was significantly less with the silicone as compared to paper tape (8.7 ± 0.5 µg/mL vs 15.2 ± 1.3 µg/mL, P < .0001). Few hairs were removed with either tape. There was significantly less (P < .0001) edge-lift with the paper tape than the silicone tape; no statistically significant differences in parent preferences for silicone versus paper tapes were measured (P = .3359). CONCLUSIONS: Gentleness assessments favored the silicone tape compared to a paper tape and warrant further clinical investigation in the neonatal intensive care unit.

Tolerability and irritation potential of four topical acne regimens in healthy subjects.

Benzoyl peroxide (BPO) is a cornerstone of acne therapy, often used in combination with a topical antibiotic and/or a retinoid. Three independent 2-week studies were conducted in healthy subjects to compare the tolerability and irritation potential of topical treatment with Duac® Gel (BPO 5%-clindamycin phosphate 1.2%) vs Acanya® Gel (BPO 2.5%-clindamycin phosphate 1.2%), Aczone® Gel (dapsone 5%), or Epiduo® Gel (BPO 2.5%-adapalene 0.1%). For each study, subjects were randomized to apply one of the comparative products on one side of the face; the contralateral side remained untreated. Primary (erythema and dryness) and secondary tolerability assessments were performed throughout the study. Independent blinded expert grader assessments of erythema found no significant overall difference between any of the comparative groups. Treatment with Epiduo Gel resulted in a significant increase in dryness and evaporative water loss values compared with Duac Gel. Overall, subject self-assessments were equally favorable across all study groups, although the Epiduo Gel group reported a higher frequency of adverse perceptions (ie mild burning/stinging). In conclusion, the four topical acne medications tested were well tolerated throughout the study period. Treatment with Epiduo Gel resulted in a significant increase in dryness, evaporative water loss, and sensations of burning and stinging. No other significant differences in self-assessment perceptions were observed between treatments.

Dry skin in the winter is related to the ceramide profile in the stratum corneum and can be improved by treatment with a Eucalyptus extract.

BACKGROUND: Dry skin in the winter has been reported to involve scaling, defects in water holding and barrier functions, and decreased ceramide (CER) levels in the stratum corneum (SC). We previously reported that a Eucalyptus extract promotes CER synthesis in cultured keratinocytes and accelerates the recovery of hydration in a barrier-disrupted model of human skin. AIMS: One of the objectives was to examine the CER profile and its contribution to the relief of dry skin. The other objective was to assess the efficacy of a Eucalyptus extract to treat dry skin. PATIENTS/METHODS: Twenty subjects with dry skin on their legs were assessed and their CER profiles were analyzed using tape-stripping. A moisturizer with a Eucalyptus extract was assessed for its effects on dry skin using a leg regression methodology comprising 28 days of treatment and 14 days of regression. RESULTS: Indicators of dry skin conditions (conductance, dryness, roughness, and scaliness) strongly correlated with the level of CER, CER [NP], and CER[NH]. Treatment with the Eucalyptus extract significantly improved conductance (3 days after regression) and transepidermal water loss (14 days after regression) compared with the placebo. After 28 days of treatment with the Eucalyptus extract, the level of CER in the SC did not increase, but CER [NP] did increase. CONCLUSIONS: These results suggest that not only the level of CER, but also specific CER species strongly contribute to dry skin relief and products that increase those are useful to improve dry skin conditions.

A randomized and controlled comparison of gentleness of 2 medical adhesive tapes in healthy human subjects.

PURPOSE: To compare gentleness of a silicone tape to a paper tape and to an untreated control. DESIGN: Controlled, randomized, grader-blinded cohort trial. SUBJECTS AND SETTING: The sample group comprised 28 healthy volunteers aged 55 years and older (median age = 63 years) with a Fitzpatrick Skin Type of I, II, or III. All volunteers were recruited from the greater Philadelphia area and the study was conducted at a dermatological research facility specializing in noninvasive instrumental measurements. METHODS: Tapes were applied and removed daily (excluding weekends) to 2 of 3 sites on the left and right volar forearms over an 11-day period. The center site on each forearm was left untreated and tapes were randomized to the proximal and distal sites. The primary assessment was transepidermal water loss (TEWL); secondary assessments included erythema/edema, denudation/skin-stripping, and subject self-evaluations. Study personnel conducting the primary and secondary assessments were not involved with treatments to maintain the blinded nature of the study. The identity of the 2 tapes was not revealed to the subjects until after conclusion of the study. RESULTS: On day 11 the mean TEWL value for the paper tape was significantly higher than that for both the untreated control and silicone tape (P < .001). End-of-study mean TEWL values were 2.65 ± 0.68 g/mh for the silicone tape, 6.85 ± 4.97 g/mh for the paper tape, and 3.73 ± 1.19 g/mh for the untreated control. At all assessments, the silicone tape exhibited net changes from baseline that were significantly less than the paper tape (P < .05 day 1, P < .001 days 4, 7, and 11) and similar for the untreated control. Only at days 4 (P < .01) and 11 (P < .001) was the paper tape significantly higher than that for the untreated control. Throughout the study, both tapes exhibited mean TEWL values within the range of normal intact forearm skin, indicating that both tapes were gentle. No differences in erythema/edema scores occurred but the silicone tape resulted in lower denudation/skin-stripping scores than the paper tape at days 4 to 11 (P < .0001). Self-assessment of pain at removal was low for both tapes but significantly lower for the silicone tape (days 1-7, P = .02; day 11, P = .009). Forty-four percent of participants expressed a preference for the silicone tape as compared to the paper tape (19%), with 37% stating no preference. CONCLUSIONS: Based on TEWL assessment of disruption of the stratum corneum water barrier, the silicone tape proved gentler to the skin than the paper tape. After 9 applications and removals over 11 days of study, the silicone tape was similar to the untreated control, whereas the paper tape exhibited significantly higher mean TEWL values than both the untreated control and the silicone tape. Expert grader assessments corroborate these findings. These data indicate that the silicone tape may provide additional gentleness when it is clinically needed.

Documentation of impaired epidermal barrier in mild and moderate diaper dermatitis in vivo using noninvasive methods.

The presence of irritants from feces and urine with the concurrent mechanical friction and occlusion creates an environment in the diapered area that renders the skin prone to diaper dermatitis. Besides being a source of discomfort to the infant, these skin irritations pose a risk of secondary infections. In this study, we used noninvasive in vivo techniques to define measurable parameters that correlate with diaper dermatitis pathophysiology. In 35 infants (16 with mild or moderate and 19 without diaper dermatitis) we compared skin of diapered areas afflicted with diaper dermatitis to lesion-free diapered sites and to skin outside the diapered area (thigh). Our findings show significantly elevated cutaneous erythema, pH, and hydration, with significantly compromised water barrier function in involved areas compared to nonlesional sites both within and outside the diapered area. Furthermore, skin pH in nonlesional diapered skin for the diaper dermatitis cohort was significantly higher compared to the nondiapered sites. These observations are consistent with the current understanding of pathological skin changes in diaper dermatitis. In this study, we demonstrate that noninvasive methods can document relevant parameters to diaper dermatitis in vivo.

Dye exclusion as a means to measure wetness protection of human skin.

BACKGROUND/PURPOSE: Excessive skin hydration from occlusive coverings such as absorbent articles, bandages, etc. has been known to compromise the skin's barrier properties. Damage to the stratum corneum occurs from prolonged exposure to wetness and limited product breathability, which reduces evaporation. Protection from wetness may be imparted by barrier materials, such as lotions and ointments on the skin. Barrier materials are traditionally applied by hand from bulk containers (bottle or tube). In recent years, diapers have been made that contain barrier ointments designed to transfer to the skin during wear. The purpose of this research was to develop a reliable in vivo method for evaluating skin wetness protection when using personal products. METHOD: The means for evaluating wetness protection in vivo is dye exclusion evaluation on human skin. Dye exclusion involves application of a barrier material, followed by dye application and skin staining evaluation. The dye exclusion method may be conducted on adult forearms with direct application of the barrier material or on infant or adult torsos after wearing a diaper or incontinence product (or other personal products) that contains the barrier material. Dye exclusion on infants used cosmetic dyes (safe for use in the eye area). RESULTS: Dye exclusion demonstrated skin protection on both adult forearms and on infant buttocks. Ointments in diapers protected the skin from the dye when diapers were worn from a few hours to several days (with appropriate changes of product). CONCLUSION: The dye exclusion method was able to demonstrate the advantage of barrier ointments for wetness protection and also to discriminate between ointment formulations.

Facial tolerability of topical retinoid therapy.

The facial tolerability of various topical retinoids was evaluated in 253 healthy volunteers in a series of split-face, randomized, investigator-masked studies-all conducted at the same site by the same investigator. Four variables were evaluated to determine if they influenced tolerability-retinoid concentration, formulation vehicle, skin sensitivity, and individual retinoid. Lower retinoid concentrations were associated with less irritation. Vehicle influenced tolerability but whether a gel or cream formulation was better tolerated varied from retinoid to retinoid. Tolerability was superior on normal skin than "sensitive skin." On normal skin, tazarotene cream was better tolerated than tretinoin cream whereas adapalene and tretinoin microsponge gels were better tolerated than tazarotene gel. On sensitive skin, tazarotene and adapalene creams were better tolerated than tretinoin cream whereas adapalene gel was better tolerated than tazarotene gel. Retinoid concentration, vehicle, skin sensitivity, and retinoid can all affect facial tolerability. Skin vulnerability may be the most important factor.

An evaluation of the moisturizing and anti-itch effects of a lactic acid and pramoxine hydrochloride cream.

An open-label, single-center, observer-blinded, controlled trial was conducted during the winter months to evaluate the moisturizing and antipruritic effects of a unique formulation of lactic acid 12% neutralized with ammonium hydroxide and pramoxine hydrochloride (HCl) 1% in 24 women with a history of dry itchy skin. Baseline assessments for appearance of dryness of both lower legs of each patient were conducted by a blinded expert grader; skin surface hydration was measured by the IBS Co, Ltd, Skicon-200 (Hamamatsu, Japan) conductivity meter; and dryness and itch were measured through self-assessment surveys. The women stopped the use of all moisturizing agents 7 days prior to and throughout the study and were allowed to use only a nonmoisturizing soap for bathing and shaving. Patients were randomized as to which leg to apply the test cream; the opposite leg was used as a nontreated control. Patients applied the test product liberally to the assigned leg twice daily for 7 days and had repeat assessments for appearance and hydration on the morning of days 3 and 7; self-assessments of itch and dryness were completed on days 1, 2, 3, 6, and 7. Expert grader assessment of skin dryness showed significant improvement with the test cream compared with no treatment on day 3 (P=.0004) and on day 7 (P<.001). Patients had statistically significant improvement in skin surface hydration by day 3 (P<.0001), with further improvement by day 7 (P<.0001). Patients also reported significant improvements in skin dryness and itch by day 1 (P<.0001 and (P<.0001, respectively), which continued to improve through day 7 (P<.0001 and P<.0001, respectively). In conclusion, the test cream was shown to be an effective moisturizer and antipruritic agent in treating dry itchy skin.