NCT00400725

Maintenance Effect of Clobex Shampoo on Participants With Moderate to Severe Scalp Psoriasis

Comparison of the Maintenance Effect of Clobex® Shampoo 0.05% Used Twice Weekly vs. Vehicle on Scalp Psoriasis in Subjects Who Successfully Responded to a 4-week Daily Course of Clobex® Shampoo 0.05%

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 288 (actual)
• Sponsor: Galderma R&D · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The objective of the study was to assess the maintenance effect on scalp psoriasis of Clobex® Shampoo 0.05% when used twice weekly.

Detailed description

Psoriasis was a chronic disease that was affecting skin, the scalp and joints. Scalp psoriasis was very common and was having an important impact on people's life. Primary objective of scalp psoriasis treatments was to gain initial and rapid control of the disease process with a minimum of side-effects and improve patient quality of life. Still, one of the unmet needs of scalp psoriasis therapies was the maintenance of a long-term remission. For corticosteroids in particular, one of the drawbacks was the disease recurrences after cessation of the treatment. Therefore, the establishment of a modified corticosteroid dosing regimen that would allow remission with minimal side-effects was suitable. The purpose of this study was to assess how long a patient successfully maintained in a good condition after use of Clobex® shampoo only twice a week.

Conditions

• Scalp Psoriasis

Interventions

Type	Name	Description
DRUG	Clobex® Shampoo	Clobex® Shampoo 0.05 % (W/W) topically to scalp for 4 weeks.
DRUG	Clobex® Vehicle Shampoo	Clobex® Vehicle Shampoo 0.05 % (W/W) topically to scalp up to 6 months.
DRUG	Clobex® Shampoo	Clobex® Shampoo 0.05% (W/W) topically to scalp up to 6 months.

Timeline

• Start date: 2006-09-29
• Primary completion: 2007-08-20
• Completion: 2007-08-20
• First posted: 2006-11-17
• Last updated: 2023-07-11
• Results posted: 2023-07-11

Locations

1 site across 1 country: Canada