Maintenance Effect of Clobex Shampoo on Subjects With Moderate to Severe Scalp Psoriasis
|ClinicalTrials.gov Identifier: NCT00400725|
Recruitment Status : Completed
First Posted : November 17, 2006
Last Update Posted : May 29, 2008
|Condition or disease||Intervention/treatment||Phase|
|Scalp Psoriasis||Drug: Clobex Shampoo 0.05% Drug: clobex shampoo placebo||Phase 3|
Psoriasis is a chronic disease that affects the skin, the scalp and joints. Scalp psoriasis is very common and can have an important impact on people's life.
Primary objective of scalp psoriasis treatments is 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 is the maintenance of a long-term remission. For corticosteroids in particular, one of the drawbacks is 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 is suitable.
The purpose of this study is to assess how long a patient can be successfully maintained in a good condition when using Clobex® shampoo only twice a week.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||288 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||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%|
|Study Start Date :||September 2006|
|Actual Study Completion Date :||August 2007|
Drug: Clobex Shampoo 0.05%
|Placebo Comparator: 2||
Drug: clobex shampoo placebo
- Global severity score [ Time Frame: 1st relapse ]
- Safety [ Time Frame: all visits ]
- Quality of Life [ Time Frame: end of study phases ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00400725
|centre de Recherche Dermatologique du Québec|
|Principal Investigator:||Poulin, MD||Centre de Recherche Dermatologique du Quebec Métropolitain|