Clinical trial NCT00400725: Maintenance Effect of Clobex Shampoo on Participants With Moderate to Severe Scalp Psoriasis
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Scalp Psoriasis
Keywords: maintenance
scalp psoriasis
Galderma
Lead sponsor: Galderma R&D
Sponsor class: INDUSTRY
First posted: 2006-11-17
Enrollment: 288
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Detailed description: Psoriasis was a chronic disease that was affecting skin, the scalp and joints. Scalp psoriasis was very common and was having an important impact on people's life.

Primary objective of scalp psoriasis treatments was 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 was the maintenance of a long-term remission. For corticosteroids in particular, one of the drawbacks was 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 was suitable.

The purpose of this study was to assess how long a patient successfully maintained in a good condition after use of Clobex® shampoo only twice a week.

Eligibility criteria: Inclusion Criteria:

* Male or female subjects aged 18 years or older.
* Subjects with moderate to severe scalp psoriasis

Exclusion Criteria:

* Subjects who needed 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

Primary outcomes:
measure: Maintenance Phase: Time to First Relapse
timeFrame: Baseline up to 24 Weeks
Secondary outcomes:
measure: Initial Phase: Percentage of Participants With Global Severity Scores
timeFrame: Baseline, Weeks 2 and 4 LOCF
measure: Initial Phase: Percentage of Participants With Pruritus Scores
timeFrame: Baseline, Weeks 2 and 4 LOCF
measure: Initial Phase: Percentage of Participants With Individual Category of Scalp Psoriasis Individual Signs (Erythema, Scaling and Plaque Thickening) Scores
timeFrame: Baseline, Weeks 2 and 4 LOCF
measure: Maintenance Phase: Percentage of Participants Who Had First Relapse
timeFrame: Baseline, Weeks 4, 8, 12, 16, 20, and 24
measure: Maintenance Phase: Percentage of Participants With Scalp Psoriasis Pruritus Score at First Time of Relapse
timeFrame: Baseline up to Week 24
measure: Maintenance Phase: Percentage of Participants With Individual Category of Scalp Psoriasis Individual Signs (Erythema, Scaling and Plaque Thickening) Scores at First Time of Relapse
timeFrame: Baseline up to Week 24
measure: Maintenance Phase: Percentage of Participants With Number of Relapses Experienced
timeFrame: Baseline up to Week 28
Other outcomes:
Locations:
city: Quebec
country: Canada
facility: centre de Recherche Dermatologique du Québec
Study officials:
affiliation: Centre de Recherche Dermatologique du Quebec Métropolitain
name: Poulin, MD
role: PRINCIPAL_INVESTIGATOR
References: