Subject Preference for Scalp Psoriasis Treatment
Information source: Galderma
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Scalp Psoriasis
Intervention: Active product - Comparator 1 (Drug); Active product - Comparator 2 (Drug); Active product - Comparator 3 (Drug)
Phase: Phase 3
Status: Active, not recruiting
Sponsored by: Galderma Official(s) and/or principal investigator(s):
Alberto Giannetti, Professor, Principal Investigator, Affiliation: Clinica Dermatologica Azienda Ospedaliera Policinico di Modena - Italy
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.
Clinical Details
Official title: Subject Preference Comparison Between Clobetasol Propionate Shampoo, 0.05% and Three Other Topical Corticosteroids in the Treatment of Moderate to Severe Scalp Psoriasis
Study design: Treatment, Randomized, Single Blind (Investigator), Active Control, Crossover Assignment, Efficacy Study
Primary outcome: Subjects' Overall preference
Secondary outcome: Global Severity score (GSS),Total severity score (TSS)
Detailed description:
This study will be a multi-centre, investigator blinded, randomized, cross-over,
intra-individual comparison in three parallel groups.
In each parallel group, Clobetasol propionate shampoo, 0. 05% will be compared to one of the
three chosen competitors, following a cross-over design.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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).
Locations and Contacts
Clinica Dermatologica Azienda Ospedaliera Policlinico di Modena, Modena 41100, Italy
Additional Information
Starting date: February 2007
Ending date: February 2008
Last updated: November 28, 2007
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