Subject Preference for Scalp Psoriasis Treatment

Galderma R&D219 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

219

Conditions

Scalp Psoriasis

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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).

Outcomes

Primary Outcomes

Percentage of Subjects Preffering Clobetasol Propionate Shampoo Better Than Comparator

Subjects' Overall preference at the end of Period II. The purpose was to demonstrate a superiority of Clobetasol propionate shampoo 0.05% therapy compared to any of three other topical comparators, in terms of subject's overall preference: "C. propionate shampoo a lot better than the comparator",C. propionate shampoo a lillte bit better than the comparator", "Comparator a lot better than C. propionate shampoo", Comparator a lillte bit better than C. propionate shampoo". This was to be shown using a non parametric two-sided Wilcoxon rank Signed test, on Intention to Treat (ITT) population.

Time frame: End of period II (up to 16 weeks)