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”

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.

Study Type: Interventional

Study Design: Treatment, Randomized, Single Blind (Investigator), Active Control, Crossover Assignment, Efficacy Study

Study Primary Completion Date: January 2008

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.

Intervention(s) in this Clinical Trial

• Drug: Active product - Comparator 1
  • Twice daily application
• Drug: Active product - Comparator 2
  • Twice daily application
• Drug: Active product - Comparator 3
  • twice daily

Arms, Groups and Cohorts in this Clinical Trial

• Active Comparator: 1
  • Clobetasol propionate Shampoo compared to comparator 1
• Active Comparator: 2
  • Clobetasol propionate Shampoo compared to comparator 2
• Active Comparator: 3
  • Clobetasol propionate Shampoo compared to comparator 3

Primary Measures

• Subjects' Overall preference
  • Time Frame: study end
    Safety Issue?: No

Secondary Measures

• Global Severity score (GSS),Total severity score (TSS)
  • Time Frame: at the end of each treatment period
    Safety Issue?: No

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).

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Galderma

Overall Clinical Trial Officials and Contacts

Alberto Giannetti, Professor Principal Investigator Clinica Dermatologica Azienda Ospedaliera Policinico di Modena - Italy  

Information obtained from ClinicalTrials.gov on September 05, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00438399

Study ID Number: RD.03.SPR.29064

ClinicalTrials.gov Identifier: NCT00438399

Health Authority: Italy: Ministry of Health