Study to Evaluate Safety, Efficacy and Tolerability of Clobetasol Propionate for Chronic Dermatitis - Full Text View

Sponsored by:	Stiefel, a GSK Company
Information provided by:	Stiefel, a GSK Company
ClinicalTrials.gov Identifier:	NCT00828464

Purpose

The purpose of the study is to assess the safety, efficacy and tolerability of Clobetasol propionate in subjects with chronic dermatitis.

Condition	Intervention	Phase
Chronic Dermatitis	Drug: clobetasol propionate	Phase IV

Study Type:	Interventional
Study Design:	Treatment, Open Label, Single Group Assignment, Safety/Efficacy Study
Official Title:	An Open Label Study to Evaluate Safety, Efficacy and Tolerability of Clobetasol Propionate for the Condition of Chronic Dermatitis

Resource links provided by NLM:

Drug Information available for: Clobetasol Clobetasol propionate

U.S. FDA Resources

Further study details as provided by Stiefel, a GSK Company:

Primary Outcome Measures:

Proportion of subjects who achieve improvement based on the Investigator's assessment at day 15 [ Time Frame: All Visits ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Proportion of subjects who achieve improvement based on the Investigator's assessment at day 8. Change in subject's visual analogue assessment scale [ Time Frame: All Visits ] [ Designated as safety issue: No ]

Enrollment:	30
Study Start Date:	October 2008
Study Completion Date:	January 2009
Primary Completion Date:	January 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental All subjects receive clobetasol propionate	Drug: clobetasol propionate Clobetasol propionate. The study product will be applied topically twice a day (morning and evening) for 14 days of treatment.

Detailed Description:

The study is being conducted in order to obtain safety, efficacy and tolerability data for Clobetasol propionate in the treatment of chronic dermatitis. The subjects must have mild to moderate disease based on the Investigator's assessment at baseline.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Subjects 18 years of age or older, with diagnosis of chronic dermatitis, able to complete the study and comply with study instructions.
Female subjects of childbearing potential must have a negative pregnancy test. Sexually active women of childbearing potential participating in the study must have been using a medically acceptable form of contraception

Exclusion Criteria:

Use of systemic corticosteroid and/or other prohibited medications within 4 weeks of the baseline visit.
Use of topical corticosteroid therapy and/or other prohibited topical medications within 2 weeks prior to the baseline visit

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00828464

Locations

United States, Kentucky
Physicians Skin Care
Louisville, Kentucky, United States, 40217

Sponsors and Collaborators

Stiefel, a GSK Company

Investigators

Study Director:

David A Angulo, MD

Stiefel Labortories, Inc., Sr. Director Global Clinical Research

More Information

No publications provided

Responsible Party:	Stiefel Laboratories ( Jason Mann/Director, Global Clincial Operations )
Study ID Numbers:	U0280-401
Study First Received:	January 22, 2009
Last Updated:	January 27, 2009
ClinicalTrials.gov Identifier:	NCT00828464 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by Stiefel, a GSK Company:

Dermatitis

Study placed in the following topic categories:

Anti-Inflammatory Agents
Clobetasol
Skin Diseases
Hormone Antagonists

Hormones, Hormone Substitutes, and Hormone Antagonists
Hormones
Glucocorticoids
Dermatitis

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Clobetasol
Skin Diseases
Therapeutic Uses
Physiological Effects of Drugs

Hormones, Hormone Substitutes, and Hormone Antagonists
Hormones
Glucocorticoids
Pharmacologic Actions
Dermatitis

ClinicalTrials.gov processed this record on September 10, 2009