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

This study has been completed.
Sponsor:
Information provided by:
Galderma
ClinicalTrials.gov Identifier:
NCT00400725
First received: November 16, 2006
Last updated: May 28, 2008
Last verified: May 2008
History of Changes

November 16, 2006
May 28, 2008
September 2006
Not Provided
Global severity score [ Time Frame: 1st relapse ]
Time to 1st relapse during the maintenance phase
Complete list of historical versions of study NCT00400725 on ClinicalTrials.gov Archive Site
  • Safety [ Time Frame: all visits ]
  • Quality of Life [ Time Frame: end of study phases ]
  • Safety
  • Quality of Life
Not Provided
Not Provided
 
Maintenance Effect of Clobex Shampoo on Subjects 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%

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

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.
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Scalp Psoriasis
  • Drug: Clobex Shampoo 0.05%
    twice weekly
  • Drug: clobex shampoo placebo
    twice weekly
  • Experimental: 1
    Intervention: Drug: Clobex Shampoo 0.05%
  • Placebo Comparator: 2
    Intervention: Drug: clobex shampoo placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
288
August 2007
Not Provided

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Canada
 
NCT00400725
RD.03.SPR.29060
Not Provided
Not Provided
Galderma
Not Provided
Principal Investigator: Poulin, MD Centre de Recherche Dermatologique du Quebec Métropolitain
Galderma
May 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP