Abstract

The objective of this study was to measure the tolerance and efficacy of a gel cream that is formulated for sensitive skin. Subjects (n = 31) had self-reported sensitive skin, corneometer measurement <40, and stinging reaction to capsaicin. Tolerance to one-time use of the gel cream was assessed by measurement of the stinging reaction of gel cream vs distilled water. The soothing potential of the gel cream was assessed using the capsaicin irritation model that measured time to reduce sensitivity after application of capsaicin. Effectiveness of the gel cream over 4 weeks of twice daily application was assessed by transepidermal water loss (TEWL), corneometer (hydration) measurements, clinical evaluation, and subject self-assessment. The gel cream was well tolerated after one-time use. The gel cream reduced stinging, itching, and burning following capsaicin challenge after 2.5 and 5 minutes (P ˂ .05) and did not induce additional irritation. Over the 4-week period, TEWL significantly decreased from the baseline mean of 22.31 at weeks 1 (−1.05), 4 (−2.53), and was retained for 2 days after discontinuing use of the gel cream (−2.18). Corneometer values increased significantly from baseline at week 4 with treatment (47.04 vs 41.94). As evaluated by the clinician, skin hydration increased throughout the study without additional redness. All subjects reported that gel cream helped reduce skin dryness at week 4. No new cases of erythema, edema, dryness, or scaling were observed. In conclusion, gel cream improved barrier function, hydration, soothed the irritated skin and was well tolerated by subjects with dry and irritant-sensitive skin.

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