Ethanol-Free Clobetasol Propionate Foam 0.05% (Olux-E Foam) vs Vehicle Foam in the Treatment of Chronic Hand Dermatitis.

• Status: Completed
• Trial end date: 2011-03-29
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to determine how clobetasol proprionate foam works against a placebo foam in the treatment of hand dermatitis.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Stiefel, a GSK Company
• Collaborator: GlaxoSmithKline
• Treatments: Clobetasol; Ethanol

Criteria

Inclusion Criteria:

• Capable of understanding and willing to provide signed informed consent

• Male or female at least 12 years of age at time of consent and at time of first dose.

• Able to complete the study and to comply with study instructions.

• Moderate to severe hand dermatitis.

• Chronic hand dermatitis diagnosis must be at least 6 months

Exclusion Criteria:

• Female who is pregnant, trying to become pregnant, or breast feeding.

• Currently diagnosed with allergic contact dermatitis.

• Participated in a previous study of the same study product.

• Had any major illness within 30 days before the screening/baseline visit.

• Considered immunocompromised.

• Has a clinically relevant history of or current evidence of abuse of alcohol or other drugs.

• Considered unable or unlikely to attend the necessary visits.