Study 203121: A Randomized, Blinded, Vehicle-Controlled, Dose-Finding Study of GSK2894512 Cream for the Treatment of Atopic Dermatitis
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- STATUS
- Recruiting
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- sponsor
- GlaxoSmithKline
Summary
Study 203121: A Randomized, Blinded, Vehicle-Controlled, Dose-Finding Study of GSK2894512 Cream for the Treatment of Atopic Dermatitis
Description
This research study will evaluate the effectiveness 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 (eczema). Results from this study will be considered when selecting the most appropriate concentration of GSK2894512 cream and application frequency in future clinical studies.
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. The study drug will be assigned and used for 12 weeks with a total of up to 9 visits.
In office visits will be conducted as follows: Screening Visit, Baseline Visit, Week 1, Week 2, Week 4, Week 8, Week 12, Week 14 and Week 16. The study drug will be assigned at baseline and returned at week 12.
Study related procedures include physical examinations, Atopic Dermatitis assessments by both the participant and study doctor, urine pregnancy tests for women of child bearing potential, blood draws, electrocardiograms (EKG's), optional photography and electronic diary entries.
There will be 6 groups, including 2 placebo groups and each group will be provided a different dose of study drug with instructions on how to apply on the affected areas. Each participant will be placed at random into one of the following groups:
- GSK2894512 1% cream; apply once daily
- GSK2894512 1% cream; apply twice daily
- GSK2894512 0.5% cream; apply once daily
- GSK2894512 0.5% cream; apply twice daily
- Placebo cream; apply once daily
- Placebo cream; apply twice daily
Details
| Condition | Eczema (Atopic Dermatitis - Pediatric), Eczema (Atopic Dermatitis) |
|---|---|
| Clinical Study Identifier | TX143627 |
| Sponsor | GlaxoSmithKline |
| Last Modified on | 23 November 2020 |
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.
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Learn moreComplete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.
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