Phase 4
N=81
Clobetasol Propionate Spray Versus Vehicle Spray for the Management of Moderate to Severe Plaque Psoriasis of the Scalp
Scalp Psoriasis
Bottom Line
View on ClinicalTrials.gov: NCT00881868 ↗Enrolled (actual)
81
Serious AEs
0.0%
Results posted
Dec 2010
Primary outcome: Primary: Number of Participants Who Were a Success or Failure Based on the Global Severity Score (GSS) of Scalp Psoriasis From Baseline to End of Treatment (Week 4 or Week 2 if Clear) — 35; 5; 6; 35 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- clobetasol propionate spray 0.05% (Drug); Vehicle spray (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Galderma R&D
- Primary completion
- Dec 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Who Were a Success or Failure Based on the Global Severity Score (GSS) of Scalp Psoriasis From Baseline to End of Treatment (Week 4 or Week 2 if Clear) |
35; 5; 6; 35 | — |
| SECONDARY Number of Participants in Each Category of the Scalp Psoriasis Individual Sign Scores (Scaling, Erythema and Plaque Elevation) at Baseline and Week 4 |
0; 0; 24; 3; 4; 2 | — |
| SECONDARY Number of Participants in Each Category of the Extent of Scalp Involvement Index at Baseline and Week 4 |
0; 0; 21; 1; 16; 12 | — |
| SECONDARY Number of Participants in Each Category of Pruritus at Baseline and Week 4 |
4; 1; 28; 8; 5; 10 | — |
Summary
The primary objective of this study is to evaluate the safety and efficacy of clobetasol propionate spray versus vehicle spray for the management of moderate to severe plaque psoriasis of the scalp.
Eligibility Criteria
Inclusion Criteria
- Subjects with diagnosis of moderate to severe plaque psoriasis of the scalp
Exclusion Criteria
- Subjects who need systemic treatment for their body psoriasis
- Subjects who have surface area involvement too large (>20% Body Surface Area [BSA]) that would require more than 50 grams per week of study product
Data sourced from ClinicalTrials.gov (NCT00881868). 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.