Phase 4 N=30 Treatment

Study to Evaluate Safety, Efficacy and Tolerability of Clobetasol Propionate for Chronic Hand Dermatitis

Hand Dermatosis

Bottom Line

View on ClinicalTrials.gov: NCT00828464 ↗

Enrolled (actual)

Serious AEs

3.3%

Results posted

Sep 2010

Primary outcome: Primary: Proportion of Subjects With at Least 1-grade Improvement From Baseline to Day 15 in Investigator's Static Global Assessment Score (ISGA) Score — 96.7 Percentage of Participants

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: clobetasol propionate (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Stiefel, a GSK Company
Primary completion: Jan 2009

Outcome Measures

Outcome	Result	p-value
PRIMARY Proportion of Subjects With at Least 1-grade Improvement From Baseline to Day 15 in Investigator's Static Global Assessment Score (ISGA) Score	96.7	—
SECONDARY Proportion of Subjects Who Achieve at Least a 1-grade Improvement Based on the ISGA at Day 8.	76.7	—
SECONDARY Change in Subject's Visual Analogue Assessment Scale	1.46	—
SECONDARY 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	73.3	—
SECONDARY 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	43.3	—
SECONDARY 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	70	—
SECONDARY Proportion of Subjects With at Least 1-Grade Improvement In the Hand Eczema Severity Index Score (HESI) for All Symptoms Present at Baseline Fingers	50	—
SECONDARY 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	56.7	—
SECONDARY 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	73.3	—
SECONDARY 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	33.3	—
SECONDARY 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	66.7	—
SECONDARY 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	40	—
SECONDARY 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	40	—
SECONDARY Change in Subject's Visual Analogue Assessment Scale From Baseline to Day 15	3.40	—

Summary

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

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00828464). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.