Phase 3
N=219
Subject Preference for Scalp Psoriasis Treatment
Scalp Psoriasis
Bottom Line
View on ClinicalTrials.gov: NCT00438399 ↗Enrolled (actual)
219
Serious AEs
1.5%
Results posted
Dec 2011
Primary outcome: Primary: Percentage of Subjects Preffering Clobetasol Propionate Shampoo Better Than Comparator — 28.5; 31.6; 21.8 Percentage of participants — p=0.0003
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- C. propionate - Corticosteroid 1 (Drug); C. propionate- Corticosteroid 2 (Drug); C. propionate -Corticosteroid 3 (Drug); Corticosteroid 1- C. propionate (Drug); Corticosteroid 2 - C. propionate (Drug); Corticosteroid 3 - C. propionate (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Galderma R&D
- Primary completion
- Jan 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Subjects Preffering Clobetasol Propionate Shampoo Better Than Comparator |
28.5; 31.6; 21.8 | 0.0003 sig |
Summary
The scalp is one of the most common affected sites in psoriatic patients as 79% of them have scalp involvement.It has also a psychological aspect with 31% of patients with scalp psoriasis indicating distress.
Topical agents remain the mainstay of treatment for scalp psoriasis. However, they are not always ideal because they might be inconvenient and messy to use, stain or damage hair.
The test shampoo, Clobetasol propionate Shampoo 0.05% (marketed in the USA under the tradename of Clobex®) was developed to provide the strongest available corticosteroid as a short-contact therapy in order to improve the chances of it being effective and reduce the potential for traditional side-effects.
The objective of this study is to compare subject's overall preference between Clobetasol propionate shampoo 0.05% and three other topical corticosteroids in the treatment of moderate to severe scalp psoriasis.
Eligibility Criteria
Inclusion Criteria
- Male or female subjects, 18 years of age or older,
- Subjects with moderate to severe scalp psoriasis,
- Subjects who signed written informed consent prior to any study procedures.
Exclusion Criteria
- Subjects who need systemic treatment for their body psoriasis,
- Subjects who are at risk in terms of precautions, warnings and contra-indication,
- Female subjects who are pregnant, nursing or planning a pregnancy during the study,
- Subjects with a specific washout period for topical treatment(s) on the scalp,
- Subjects with a specific washout period for systemic treatment(s).
Data sourced from ClinicalTrials.gov (NCT00438399). 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.