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

Condition(s) targeted: Scalp Psoriasis

Intervention: Clobex Shampoo 0.05% (Drug); clobex shampoo placebo (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Galderma

Official(s) and/or principal investigator(s):
Poulin, MD, Principal Investigator, Affiliation: Centre de Recherche Dermatologique du Quebec Métropolitain

The objective of the study is to assess the maintenance effect on scalp psoriasis of Clobex® Shampoo 0. 05% when used twice weekly.

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

Primary outcome: Global severity score

Secondary outcome:

Safety

Quality of Life

Detailed description: 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.

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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

centre de Recherche Dermatologique du Québec, Quebec, Canada

Starting date: September 2006
Ending date: August 2007
Last updated: May 28, 2008