A Dose-Finding Study of GSK2894512 Cream in Subjects With Atopic Dermatitis (AD)
Status:
Completed
Trial end date:
2017-01-12
Target enrollment:
Participant gender:
Summary
This study will evaluate the efficacy and safety of two concentrations (0.5 percent [%] and
1%) and two application frequencies (once a day and twice a day) of GSK2894512 cream for the
topical treatment in adolescent and adult subjects with atopic dermatitis. Results from this
study will be considered when selecting the most appropriate concentration of GSK2894512
cream and application frequency in future clinical studies. This is a multicenter (United
States, Canada, and Japan), randomized, double-blind (sponsor-unblind), vehicle-controlled,
6-arm, parallel-group, dose-finding study in adolescent and adult subjects with atopic
dermatitis. Two concentrations of GSK2894512 cream (0.5% and 1%) and a vehicle control cream
will be equally randomized and evaluated following application to all atopic dermatitis
lesions (except on the scalp) once daily (evening) or twice daily (morning and evening) for
12 weeks. This study will consist of 3 periods: up to 4 weeks screening, 12 weeks
double-blind treatment, and 4 weeks post-treatment follow-up. The total duration of subject
participation will be approximately 16 to 20 weeks. Approximately 270 adolescent and adult
males and females subjects with atopic dermatitis will be screened in order to have at least
228 randomized subjects (38 subjects for each of the 6 treatment groups) and approximately
204 evaluable subjects overall. Approximately 30 subjects will be randomized in Japan to
achieve at least 24 evaluable Japanese subjects.