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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

125 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-11-15

Study Completion Date

2011-03-29

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Dermatitis, Chronic

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Clobetasol Propionate 0.05%

Group Type ACTIVE_COMPARATOR

clobetasol propionate 0.05%

Intervention Type DRUG

2 times a day, 14 total days study treatment

Vehicle

Group Type PLACEBO_COMPARATOR

Vehicle / Placebo

Intervention Type DRUG

2 times a day, 14 total days of study treatment

Interventions

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clobetasol propionate 0.05%

2 times a day, 14 total days study treatment

Intervention Type DRUG

Vehicle / Placebo

2 times a day, 14 total days of study treatment

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No