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%”

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

Study Type: Interventional

Study Design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study

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.

Intervention(s) in this Clinical Trial

• Drug: Clobex Shampoo 0.05%
  • twice weekly
• Drug: clobex shampoo placebo
  • twice weekly

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1
• Placebo Comparator: 2

Primary Measures

• Global severity score
  • Time Frame: 1st relapse
    

Secondary Measures

• Safety
  • Time Frame: all visits
    
• Quality of Life
  • Time Frame: end of study phases
    

Inclusion Criteria:

• Male or female subjects aged 18 years or older.
• Subjects with moderate to severe scalp psoriasis

Exclusion Criteria:

• Subjects who need systemic treatment for their body psoriasis
• Subjects with a washout period for topical treatment(s) on the scalp less than:
• Corticosteroids 2 weeks
• All other anti-psoriasis medications 2 weeks
• Subjects with a washout period for systemic treatment(s) less than:
• PUVA therapy 4 weeks
• Biological therapies 12 weeks
• Treatments other than biologicals with a possible efficacy on psoriasis 4 weeks
• Treatment known to worsen psoriasis 2 weeks

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

Poulin, MD Principal Investigator Centre de Recherche Dermatologique du Quebec Métropolitain  

Information obtained from ClinicalTrials.gov on October 07, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00400725

Study ID Number: RD.03.SPR.29060

ClinicalTrials.gov Identifier: NCT00400725

Health Authority: Canada: Health Canada