NCT00438399

Subject Preference for Scalp Psoriasis Treatment

Subject Preference Comparison Between Clobetasol Propionate Shampoo, 0.05% and Three Other Topical Corticosteroids in the Treatment of Moderate to Severe Scalp Psoriasis

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 219 (actual)
• Sponsor: Galderma R&D · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Scalp Psoriasis

Interventions

Type	Name	Description
DRUG	C. propionate - Corticosteroid 1	Twice daily application
DRUG	C. propionate- Corticosteroid 2	Twice daily application
DRUG	C. propionate -Corticosteroid 3	Twice daily application
DRUG	Corticosteroid 1- C. propionate	Twice daily application
DRUG	Corticosteroid 2 - C. propionate	Twice daily application
DRUG	Corticosteroid 3 - C. propionate	Twice daily application

Timeline

• Start date: 2007-02-01
• Primary completion: 2008-01-01
• Completion: 2008-02-01
• First posted: 2007-02-22
• Last updated: 2021-02-18
• Results posted: 2011-12-23

Locations

1 site across 1 country: Italy