Phase 4
Completed N=30
Study to Evaluate Safety, Efficacy and Tolerability of Clobetasol Propionate for Chronic Hand Dermatitis
Hand Dermatosis
Source: ClinicalTrials.gov NCT00828464 ↗
Enrolled (actual)
30
Serious AEs
3.3%
Results posted
Sep 2010
Primary outcomePrimary: 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
Summary
The purpose of the study is to assess the safety, efficacy and tolerability of Clobetasol propionate foam in subjects with chronic dermatitis.
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 | — |
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
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. Informational only — not medical advice.