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
  Purpose

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


Condition Intervention Phase
Scalp Psoriasis
Drug: Clobex Shampoo 0.05%
Drug: clobex shampoo placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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%

Resource links provided by NLM:


Further study details as provided by Galderma:

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

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

Enrollment: 288
Study Start Date: September 2006
Study Completion Date: August 2007
Arms Assigned Interventions
Experimental: 1 Drug: Clobex Shampoo 0.05%
twice weekly
Placebo Comparator: 2 Drug: clobex shampoo placebo
twice weekly

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00400725

Locations
Canada
centre de Recherche Dermatologique du Québec
Quebec, Canada
Sponsors and Collaborators
Galderma
Investigators
Principal Investigator: Poulin, MD Centre de Recherche Dermatologique du Quebec Métropolitain
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00400725     History of Changes
Other Study ID Numbers: RD.03.SPR.29060
Study First Received: November 16, 2006
Last Updated: May 28, 2008
Health Authority: Canada: Health Canada

Keywords provided by Galderma:
maintenance
scalp psoriasis
Galderma

Additional relevant MeSH terms:
Psoriasis
Skin Diseases
Skin Diseases, Papulosquamous
Clobetasol
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on October 22, 2014