Conditions: Dermatitis, Atopic
Keywords: Atopic Dermatitis GW870086X TIS IGA
Allocation: RANDOMIZED | Intervention model: CROSSOVER
Enrollment: 25
Healthy volunteers: no

Brief summary:
This study is a randomised, double-blind, placebo-controlled study to assess the efficacy of GW870086X cream formulation in subjects with moderate to severe atopic dermatitis. Subjects will be assigned to take 3 out of the 4 possible treatments for 21 ±2 days: GW870086X 0.2% cream, GW870086X 2% cream, FP 0.05% cream (as a positive control) and placebo cream. All subjects will be randomised to receive placebo cream. Three index lesions located on the arms and/or legs (one on each) will be identified per subject and each treatment will be applied to the same lesion.

Detailed description:
This study is a randomised, double-blind, placebo-controlled study to assess the efficacy of GW870086X cream formulation in subjects with moderate to severe atopic dermatitis. The primary objective of this study is to assess 3 lesions using the Three Item Severity (TIS) score. The secondary objectives are to assess safety and tolerability of GW870086X, assess individual lesions using the Investigators Global Assessment (IGA) and to assess the pharmacokinetics of 21 days dosing of GW870086X administered as a cream. Twenty-five (25) subjects with atopic dermatitis will be randomised to receive placebo and 2 of the following treatments: GW870086X 0.2%, GW870086X 2%, FP 0.05% and placebo. All subjects will receive placebo. Subjects will apply all 3 treatments once daily during the 21 day treatment period. Three index lesions located on the arms and/or legs (one on each) will be identified per subject and each treatment will be applied to the same lesion throughout the 21±2 day treatment period. Each index lesion should represent the most common lesions for each patient i.e. not the most or least severe lesions.

Arms:
arm 1: GW870086 2.0%, GW870086 0.2% \&amp; Placebo each applied to a separate specific lesion for 21±2 days. arm 2: GW870086 2.0%, FP 0.05% \&amp; Placebo each applied to a separate specific lesion for 21±2 days. arm 3: GW870086 0.2%, FP 0.05% \&amp; Placebo each applied to a separate specific lesion for 21±2 days.

Interventions: intervention 1: GW870086 2.0% intervention 2: GW870086 0.2% intervention 3: FP 0.05% intervention 4: Placebo
Intervention descriptions: intervention 1: White to slightly colored opaque cream intervention 2: White to slightly colored opaque cream intervention 3: White cream intervention 4: White to slightly colored opaque cream

Protocol document: