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

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ClinicalTrials.gov Identifier: NCT00400725
Recruitment Status : Completed
First Posted : November 17, 2006
Last Update Posted : May 29, 2008
Information provided by:

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

Condition or disease Intervention/treatment Phase
Scalp Psoriasis Drug: Clobex Shampoo 0.05% Drug: clobex shampoo placebo Phase 3

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 288 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Study Completion Date : August 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Psoriasis
U.S. FDA Resources

Arm Intervention/treatment
Experimental: 1 Drug: Clobex Shampoo 0.05%
twice weekly
Placebo Comparator: 2 Drug: clobex shampoo placebo
twice weekly

Primary Outcome Measures :
  1. Global severity score [ Time Frame: 1st relapse ]

Secondary Outcome Measures :
  1. Safety [ Time Frame: all visits ]
  2. Quality of Life [ Time Frame: end of study phases ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00400725

centre de Recherche Dermatologique du Québec
Quebec, Canada
Sponsors and Collaborators
Principal Investigator: Poulin, MD Centre de Recherche Dermatologique du Quebec Métropolitain

Additional Information:
ClinicalTrials.gov Identifier: NCT00400725     History of Changes
Other Study ID Numbers: RD.03.SPR.29060
First Posted: November 17, 2006    Key Record Dates
Last Update Posted: May 29, 2008
Last Verified: May 2008

Keywords provided by Galderma:
scalp psoriasis

Additional relevant MeSH terms:
Skin Diseases, Papulosquamous
Skin Diseases
Anti-Inflammatory Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs