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

NCT ID: NCT00400725

Last Updated: 2023-07-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 288 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-09-29
• Study Completion Date: 2007-08-20

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.

Conditions

Scalp Psoriasis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Initial Phase:- Clobex® Shampoo

In initial open-label phase, participants were applied Clobex® shampoo (Clobetasol Propionate) 0.05 percent (%) weight by weight (W/W) topically to the scalp once daily (twice a week) for 4 weeks (weekly dose was not more than 50 grams \[50 Milliliter\]).

Group Type: EXPERIMENTAL

Clobex® Shampoo

Intervention Type: DRUG

Clobex® Shampoo 0.05 % (W/W) topically to scalp for 4 weeks.

Maintenance Phase: Clobex® Shampoo

In maintenance double-blind phase, participants presented with a good efficacy (Global severity score \[GSS\] less than or equal to \[\<=\] 2) in initial phase were randomized to apply Clobetasol Propionate shampoo 0.05 % weight by weight (W/W) twice weekly up to 6 months (wherein weekly dose were not exceeded beyond 50 grams \[50 milliliter\]). In case of relapse (that is \[i.e.\], GSS greater than \[\>\] 2) participants were re-entered to 4-week daily treatment with Clobetasol Propionate shampoo 0.05%. After this 4-week period of daily treatment, if GSS \<= 2, participants were re-entering the maintenance regimen (twice a week).

Group Type: EXPERIMENTAL

Clobex® Shampoo

Intervention Type: DRUG

Clobex® Shampoo 0.05% (W/W) topically to scalp up to 6 months.

Maintenance Phase: Clobex® Vehicle Shampoo

In maintenance double-blind phase, participants presented with a good efficacy (Global severity score \[GSS\] \<= 2) in initial phase were randomized to apply Clobex® vehicle shampoo twice weekly up to 6 months (wherein weekly dose was not more than 50 grams \[50 milliliter\]). In case of relapse (i.e., GSS \[greater than\] \> 2) participants were re-entered to 4-week daily treatment with Clobetasol Propionate Shampoo 0.05 % (W/W). After this 4-week period of daily treatment, if GSS \<= 2, participants were re-entering the maintenance regimen (twice a week).

Group Type: PLACEBO_COMPARATOR

Clobex® Vehicle Shampoo

Intervention Type: DRUG

Clobex® Vehicle Shampoo 0.05 % (W/W) topically to scalp up to 6 months.

Interventions

Clobex® Shampoo

Clobex® Shampoo 0.05 % (W/W) topically to scalp for 4 weeks.

Intervention Type: DRUG

Clobex® Vehicle Shampoo

Clobex® Vehicle Shampoo 0.05 % (W/W) topically to scalp up to 6 months.

Intervention Type: DRUG

Clobex® Shampoo

Clobex® Shampoo 0.05% (W/W) topically to scalp up to 6 months.

Intervention Type: DRUG

Other Intervention Names

Clobetasol Propionate 0.05% [weight by weight (W/W)]; Clobetasol Propionate 0.05% (W/W)

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Galderma R&D

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Poulin, MD

Role: PRINCIPAL_INVESTIGATOR

Centre de Recherche Dermatologique du Quebec Métropolitain

Locations

centre de Recherche Dermatologique du Québec

Québec, , Canada

Countries

Canada

Related Links

http://www.clobex.com

Related Info

Other Identifiers

RD.03.SPR.29060

Identifier Type: -

Identifier Source: org_study_id