Maintenance Effect of Clobex Shampoo on Subjects With Moderate to Severe Scalp Psoriasis
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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% |
- Global severity score [ Time Frame: 1st relapse ]
- 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 |
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 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, Papulosquamous Skin Diseases Clobetasol Anti-Inflammatory Agents Therapeutic Uses |
Pharmacologic Actions Glucocorticoids Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on May 21, 2013