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

NCT01323673

CompletedPhase 4

Sponsor: Stiefel, a GSK Company

Conditions: Dermatitis, Chronic

Interventions: clobetasol propionate 0.05%, Vehicle / Placebo

Countries: United States

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

Eligibility overview

Sex: ALL

Age: 12 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility 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.

Locations (10)

San Diego, California, United States
Boynton Beach, Florida, United States
West Palm Beach, Florida, United States
Louisville, Kentucky, United States
Louisville, Kentucky, United States
Belleville, New Jersey, United States
Montclair, New Jersey, United States
Knoxville, Tennessee, United States
Nashville, Tennessee, United States
Austin, Texas, United States