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

Stiefel

Status and phase

Completed

Phase 4

Conditions

Dermatitis, Chronic

Treatments

Drug: clobetasol propionate 0.05%

Drug: Vehicle / Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT01323673

115054

Details and patient eligibility

About

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

Full description

Topical corticosteroids have anti-inflammatory, immunosuppressive and antiproliferative properties. Clobetasol propionate foam 0.05% (Olux-E), a Class 1 corticosteroid, is formulated in an ethanol free petrolatum base that provides the benefits of a super-potent corticosteroid combined with moisturizing ingredients in the treatment of corticosteroid responsive dermatoses. The current study is designed to show efficacy and safety in the treatment of moderate to severe chronic hand dermatitis.

Enrollment

125 patients

Sex

All

Ages

12+ years old

Volunteers

No Healthy Volunteers

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.