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

Information source: GlaxoSmithKline
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Dermatitis, Chronic

Intervention: clobetasol propionate 0.05% (Drug); Vehicle / Placebo (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Stiefel, a GSK Company

Official(s) and/or principal investigator(s):
GSK Clinical Trials, Study Director, Affiliation: GlaxoSmithKline

Summary

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

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: Number of Participants With Improvement of at Least 2 Grades in the Investigator's Static Global Assessment (ISGA) (Target Hand) Score From Baseline to Day 15

Secondary outcome:

Number of Participants With an Improvement of at Least 1 Grade in the ISGA (Target Hand) Score From Baseline to Day 15

Number of Participants With an Improvement of at Least 2 Grades in the ISGA (Target Hand) Score From Baseline to Day 3 and to Day 8

Number of Participants With an Improvement of at Least 1 Grade in the ISGA (Target Hand) Score From Baseline to Day 3 and and to Day 8

Number of Participants With an ISGA (Target Hand) Score of 0 or 1 at Days 3, 8, and 15

Number of Participants With an Improvement of at Least 1 Grade in the Subject Global Assessment (SGA) (Target Hand) Score From Baseline to Days 3, 8, and 15

Number of Participants With an SGA (Target Hand) Score of 0 or 1 at Days 3, 8, and 15

Percent Change From Baseline in Pruritus, Stinging, Burning, and Pain Scores (Target Hand) at Days 3, 8, and 15

Detailed 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.

Eligibility

Minimum age: 12 Years. Maximum age: N/A. Gender(s): Both.

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 and Contacts

GSK Investigational Site, Boynton Beach, Florida 33437, United States

GSK Investigational Site, West Palm Beach, Florida 33401, United States

GSK Investigational Site, Louisville, Kentucky 40217, United States

GSK Investigational Site, Louisville, Kentucky 40202, United States

GSK Investigational Site, Belleville, New Jersey 07109, United States

GSK Investigational Site, Montclair, New Jersey 07042, United States

GSK Investigational Site, Knoxville, Tennessee 37922, United States

GSK Investigational Site, Nashville, Tennessee 37215, United States

GSK Investigational Site, Austin, Texas 78759, United States

Additional Information

Starting date: November 2010
Last updated: February 23, 2012

Page last updated: August 23, 2015

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