Dermatitis, Atopic Clinical Trial
Official title:
A Randomised, Double-blind (for GW870086), Placebo-controlled Study of Topical GW870086 Formulation to Explore the Potential for Skin Thinning in Healthy Adult Volunteers
This study is a randomised, double-blind, placebo-controlled study of topical GW870086 to explore the potential for skin thinning in healthy adult volunteers after 42±2 days of treatment. Twenty (20) healthy volunteers will be randomised to receive placebo and GW870086 2% cream, they will also receive either of the following treatments: GW870086 0.2% cream, or clobetasol propionate 0.05% cream.
This study is a randomised, double-blind, placebo-controlled study of topical GW870086 to
explore the potential for skin thinning in healthy adult volunteers after 42±2 days of
treatment. The primary objective of this study is to assess the thickness of the skin using
ultrasound. The secondary objectives are to assess skin thinning using a visual scale for
skin atrophy and telangiectasia, safety and tolerability of GW870086 and to assess the
pharmacokinetics of GW870086 administered as a cream for 42±2 days.
Twenty (20) healthy volunteers will be randomised to receive placebo and GW870086 2% cream.
They will also receive either of the following treatments: GW870086 0.2% cream, or clobetasol
propionate 0.05% cream. Subjects will apply all 3 treatments once daily during the 42±2 day
treatment period. However subjects who are randomised to receive the unblinded clobetasol
propionate will only apply this once daily for a maximum of 21±2 days but will continue to
dose with the other 2 treatments. If significant evidence of skin thinning is observed in any
of the treatment arms (25% reduction in skin thickness measured using ultrasound) then
application of this treatment will be discontinued. Three areas of approximately 5 x 5 cm on
the arm will be identified and each treatment will be applied to the same area throughout the
42±2 day treatment period.
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