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Subject Preference for Scalp Psoriasis Treatment

Information source: Galderma
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Scalp Psoriasis

Intervention: 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)

Phase: Phase 3

Status: Completed

Sponsored by: Galderma

Official(s) and/or principal investigator(s):
Alberto Giannetti, Professor, Principal Investigator, Affiliation: Clinica Dermatologica Azienda Ospedaliera Policinico di Modena - Italy


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: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Primary outcome: Percentage of Subjects Preffering Clobetasol Propionate Shampoo Better Than Comparator

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.


Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.


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

Study product information

Starting date: February 2007
Last updated: November 21, 2011

Page last updated: August 23, 2015

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