Phase 4
Completed N=125
Ethanol-Free Clobetasol Propionate Foam 0.05% (Olux-E Foam) vs Vehicle Foam in the Treatment of Chronic Hand Dermatitis.
Dermatitis, Chronic
Source: ClinicalTrials.gov NCT01323673 ↗
Enrolled (actual)
125
Serious AEs
0.0%
Results posted
Dec 2011
Primary outcomePrimary: Number of Participants With Improvement of at Least 2 Grades in the Investigator's Static Global Assessment (ISGA) (Target Hand) Score From Baseline to Day 15 — 26; 18 participants — p=0.151
Summary
The purpose of this study is to determine how clobetasol proprionate foam works against a placebo foam in the treatment of hand dermatitis.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Improvement of at Least 2 Grades in the Investigator's Static Global Assessment (ISGA) (Target Hand) Score From Baseline to Day 15 |
26; 18 | 0.151 |
| SECONDARY Number of Participants With an Improvement of at Least 1 Grade in the ISGA (Target Hand) Score From Baseline to Day 15 |
45; 38 | — |
| SECONDARY Number of Participants With an Improvement of at Least 2 Grades in the ISGA (Target Hand) Score From Baseline to Day 3 and to Day 8 |
2; 3; 12; 11 | — |
| SECONDARY Number of Participants With an Improvement of at Least 1 Grade in the ISGA (Target Hand) Score From Baseline to Day 3 and and to Day 8 |
24; 14; 36; 32 | — |
| SECONDARY Number of Participants With an ISGA (Target Hand) Score of 0 or 1 at Days 3, 8, and 15 |
2; 2; 11; 9; 24; 17 | — |
| SECONDARY Number of Participants With an Improvement of at Least 1 Grade in the Subject Global Assessment (SGA) (Target Hand) Score From Baseline to Days 3, 8, and 15 |
28; 25; 44; 35; 51; 33 | — |
| SECONDARY Number of Participants With an SGA (Target Hand) Score of 0 or 1 at Days 3, 8, and 15 |
7; 4; 16; 10; 32; 14 | — |
| SECONDARY Percent Change From Baseline in Pruritus, Stinging, Burning, and Pain Scores (Target Hand) at Days 3, 8, and 15 |
-29.4; -11.5; -48.3; -20.3; -65.7; -25.3 | — |
Eligibility Criteria
Inclusion Criteria
- Capable of understanding and willing to provide signed informed consent
- Male or female at least 12 years of age at time of consent and at time of first dose.
- Able to complete the study and to comply with study instructions.
- Moderate to severe hand dermatitis.
- Chronic hand dermatitis diagnosis must be at least 6 months
Exclusion Criteria
- Female who is pregnant, trying to become pregnant, or breast feeding.
- Currently diagnosed with allergic contact dermatitis.
- Participated in a previous study of the same study product.
- Had any major illness within 30 days before the screening/baseline visit.
- Considered immunocompromised.
- Has a clinically relevant history of or current evidence of abuse of alcohol or other drugs.
- Considered unable or unlikely to attend the necessary visits.
Data sourced from ClinicalTrials.gov (NCT01323673). 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.