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Study to Evaluate Safety, Efficacy and Tolerability of Clobetasol Propionate for 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: Hand Dermatosis

Intervention: clobetasol propionate (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 the study is to assess the safety, efficacy and tolerability of Clobetasol propionate foam in subjects with chronic dermatitis.

Clinical Details

Official title: An Open Label Study to Evaluate Safety, Efficacy and Tolerability of Clobetasol Propionate for the Condition of Chronic Hand Dermatitis

Study design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Proportion of Subjects With at Least 1-grade Improvement From Baseline to Day 15 in Investigator's Static Global Assessment Score (ISGA) Score

Secondary outcome:

Proportion of Subjects Who Achieve at Least a 1-grade Improvement Based on the ISGA at Day 8.

Change in Subject's Visual Analogue Assessment Scale

Proportion of Subjects at Day 15 With at Least 1-Grade Improvement In the Hand Eczema Severity Index Score (HESI) for All Symptoms Present at Baseline Finger Tips

Proportion of Subjects at Day 8 With at Least 1-Grade Improvement In the Hand Eczema Severity Index Score (HESI) for All Symptoms Present at Baseline Finger Tips

Proportion of Subjects at Day 15 With at Least 1-Grade Improvement In the Hand Eczema Severity Index Score (HESI) for All Symptoms Present at Baseline - Fingers

Proportion of Subjects With at Least 1-Grade Improvement In the Hand Eczema Severity Index Score (HESI) for All Symptoms Present at Baseline Fingers

Proportion of Subjects at Day 8 With at Least 1-Grade Improvement In the Hand Eczema Severity Index Score (HESI) for All Symptoms Present at Baseline Palm of Hands

Proportion of Subjects at Day 15 With at Least 1-Grade Improvement In the Hand Eczema Severity Index Score (HESI) for All Symptoms Present at Baseline Palm of Hands

Proportion of Subjects at Day 8 With at Least 1-Grade Improvement In the Hand Eczema Severity Index Score (HESI) for All Symptoms Present at Baseline Back of Hands

Proportion of Subjects at Day 15 With at Least 1-Grade Improvement In the Hand Eczema Severity Index Score (HESI) for All Symptoms Present at Baseline Back of Hands

Proportion of Subjects at Day 8 With at Least 1-Grade Improvement In the Hand Eczema Severity Index Score (HESI) for All Symptoms Present at Baseline Wrists

Proportion of Subjects at Day 15 With at Least 1-Grade Improvement In the Hand Eczema Severity Index Score (HESI) for All Symptoms Present at Baseline Wrists

Change in Subject's Visual Analogue Assessment Scale From Baseline to Day 15

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

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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

Locations and Contacts

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

Starting date: October 2008
Last updated: September 21, 2012

Page last updated: August 23, 2015

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