Randomised, Double-blind, Placebo-controlled Study of Topical Clobetasone Butyrate 0.05% Cream in Subjects With Eczema for Two Weeks to Evaluate the Efficacy and Safety

NCT01567995 PHASE3 COMPLETED

This was a multicenter, randomised, double-blind, two treatment arms, vehicle (cream base) -controlled, parallel-group study in subjects with moderate to severe eczema (defined by investigators global assessment (IGA) score greater than or equal to 3). Subjects were screened within 3 days prior to randomization. At the screen visit, subjects gave informed consent and were then assessed for health status and eligibility for inclusion in the study. At the baseline visit, subject eligibility was assessed for randomization (Day 0). Eligible subjects were randomised to Clobetasone Butyrate 0.05% Cream group or vehicle (cream base) group at the rate of 1:1. During the treatment phase, subjects returned to the sites in day 7 post-baseline visit for assessment of their disease status and eligibility to continue on the study. During the final visit, 14 days after the baseline, subjects returned to the study sites for assessment of their disease status before completing the study. In addition, the safety and tolerability of Clobetasone Butyrate 0.05% cream were also assessed through the whole trial.

Details

Lead sponsor	GlaxoSmithKline
Phase	PHASE3
Status	COMPLETED
Enrolment	240
Start date	Thu Feb 28 2008 00:00:00 GMT+0000 (Coordinated Universal Time)
Completion	Tue Feb 10 2009 00:00:00 GMT+0000 (Coordinated Universal Time)

Conditions

• Eczema

Interventions

• Clobetasone Butyrate 0.05% Cream
• Vehicle (base cream)

Countries

China