Journal of drugs in dermatology : JDD · 2021
Vehicle Effects on the Rosacea Skin Barrier.
Клиническое исследование II фазыСтатьяНазвание и аннотация: Перевод пока не подготовлен
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Draelos Zoe Diana
Аннотация
BACKGROUND: 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.
OBJECTIVE: 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.
METHODS: 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.
RESULTS: 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.
CONCLUSION: 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.
OBJECTIVE: 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.
METHODS: 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.
RESULTS: 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.
CONCLUSION: 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.