NCT01567995

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

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 240 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: All
• Age: 12 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Eczema

Interventions

Type	Name	Description
DRUG	Clobetasone Butyrate 0.05% Cream	Clobetasone Butyrate 0.05% Cream
DRUG	Vehicle (base cream)	Vehicle (base cream)

Timeline

• Start date: 2008-02-28
• Primary completion: 2009-01-01
• Completion: 2009-02-10
• First posted: 2012-04-02
• Last updated: 2017-11-28

Locations

7 sites across 1 country: China