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



Status:Completed
Conditions:Dermatology
Therapuetic Areas:Dermatology / Plastic Surgery
Healthy:No
Age Range:12 - Any
Updated:6/22/2018
Start Date:November 15, 2010
End Date:March 29, 2011

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

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.

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.
We found this trial at
9
sites
Louisville, Kentucky 40202
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Austin, Texas 78705
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Belleville, New Jersey 07109
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Boynton Beach, Florida 33472
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Knoxville, Tennessee 37916
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Montclair, New Jersey 07042
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Montclair, NJ
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Nashville, Tennessee 37203
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Nashville, TN
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San Diego, California 92111
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San Diego, CA
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West Palm Beach, Florida 33409
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West Palm Beach, FL
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