Clinical trial NCT00828464: Study to Evaluate Safety, Efficacy and Tolerability of Clobetasol Propionate for Chronic Hand Dermatitis
Official title: An Open Label Study to Evaluate Safety, Efficacy and Tolerability of Clobetasol Propionate for the Condition of Chronic Hand Dermatitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hand Dermatosis
Keywords: Dermatosis, Dermatitis, Dry skin, Irritated skin
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
Collaborators: name: GlaxoSmithKline
First posted: 2009-01-26
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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

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 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

Primary outcomes:
measure: Proportion of Subjects With at Least 1-grade Improvement From Baseline to Day 15 in Investigator's Static Global Assessment Score (ISGA) Score
timeFrame: Baseline, Day 15
Secondary outcomes:
measure: Proportion of Subjects Who Achieve at Least a 1-grade Improvement Based on the ISGA at Day 8.
timeFrame: Baseline, Day 8
measure: Change in Subject's Visual Analogue Assessment Scale
timeFrame: Baseline, Day 8
measure: 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
timeFrame: Baseline, Day 15
measure: 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
timeFrame: Baseline, Day 8
measure: 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
timeFrame: Baseline, Day 15
measure: Proportion of Subjects With at Least 1-Grade Improvement In the Hand Eczema Severity Index Score (HESI) for All Symptoms Present at Baseline Fingers
timeFrame: Baseline, Day 8
measure: 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
timeFrame: Baseline, Day 8
measure: 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
timeFrame: Baseline, Day 15
measure: 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
timeFrame: Baseline, Day 8
measure: 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
timeFrame: Baseline, Day 15
measure: 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
timeFrame: Baseline, Day 8
measure: 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
timeFrame: Baseline, Day 15
measure: Change in Subject's Visual Analogue Assessment Scale From Baseline to Day 15
timeFrame: Baseline, Day 15
Other outcomes:
Locations:
city: Louisville
country: United States
facility: Physicians Skin Care
state: Kentucky
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
citation: Kircik LH, Tropmann C. Treatment of mild-to-moderate chronic hand dermatitis with clobetasol propionate 0.05% EF foam: results from an open-label study. J Drugs Dermatol. 2011 Dec;10(12):1398-402.