Abstract

Inflammatory papulopustular rosacea produces sensitive facial skin. Thus, medications designed for rosacea require careful vehicle development to insure optimal drug delivery in an environment suitable for barrier repair. The objective of this phase 1 study was to elucidate the barrier effects of an investigational topical minocycline anhydrous gel 3% in subjects with inflammatory rosacea. 31 male or female subjects with all complexion types and moderate facial rosacea, defined as 15+ inflammatory facial lesions, were enrolled in this single-site study to evaluate the effects of an investigational topical 3% minocycline anhydrous gel vehicle on skin barrier function; the new topical minocycline gel is an investigational product under development and has completed a phase 2b study in rosacea patients. Following a 30-minute acclimation period, subjects underwent a one-minute transepidermal water loss (TEWL) measurement on the left cheek and triplicate pin probe corneometry measurements from the right cheek. Subjects used the investigational topical 3% minocycline anhydrous gel every evening and returned to the research center at day 1, week 2, and week 4. 30/31 subjects completed the research study. The study medication produced a 23% (P=0.003) increase in skin hydration at day 1 and maintained the hydration increase with a 22% (P=0.003) increase at week 2 and a 20% increase (P=0.001) at week 4. Simultaneously, skin barrier function also improved with an 11% reduction in TEWL at day 1 followed by an 18% reduction in TEWL at week 2 (P=0.001) and a 28% decrease in TEWL at week 4 (P<0.001). This improvement in skin barrier was due to a combination of skin healing and the moisturizing properties of the investigational topical 3% minocycline anhydrous gel medication evaluated in this study. The investigational topical 3% minocycline anhydrous gel decreases TEWL, indicating barrier repair, while increasing corneometry measurements, indicating improved skin hydration. J Drugs Dermatol. 2021;20(6):630-632. doi:10.36849/JDD.6105Visit the rosacea resource center.

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