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

NCT00400725 | Completed Phase 3 Results

• 1 other identifier: RD.03.SPR.29060
• Study Type: interventional
• Target: 288
• Locations: 1 country
• Sites: 1

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.

Conditions

Scalp Psoriasis

Keywords

maintenance; scalp psoriasis; Galderma

Outcome Measures

Primary Outcomes (1)

• Maintenance Phase: Time to First Relapse

  Time to first relapse was defined as the duration between baseline of maintenance phase and the visit where the relapse occurred. The first relapse was defined as the first time during the maintenance phase when participant presented with a GSS \>2.

  Baseline up to 24 Weeks

Secondary Outcomes (7)

• Initial Phase: Percentage of Participants With Global Severity Scores

  Baseline, Weeks 2 and 4 LOCF

• Initial Phase: Percentage of Participants With Pruritus Scores

  Baseline, Weeks 2 and 4 LOCF

• Initial Phase: Percentage of Participants With Individual Category of Scalp Psoriasis Individual Signs (Erythema, Scaling and Plaque Thickening) Scores

  Baseline, Weeks 2 and 4 LOCF

• Maintenance Phase: Percentage of Participants Who Had First Relapse

  Baseline, Weeks 4, 8, 12, 16, 20, and 24

• Maintenance Phase: Percentage of Participants With Scalp Psoriasis Pruritus Score at First Time of Relapse

  Baseline up to Week 24

Study Arms (3)

Initial Phase:- Clobex® Shampoo

EXPERIMENTAL

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 \[50 Milliliter\]).

Drug: Clobex® Shampoo

Maintenance Phase: Clobex® Shampoo

EXPERIMENTAL

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).

Drug: Clobex® Shampoo

Maintenance Phase: Clobex® Vehicle Shampoo

PLACEBO COMPARATOR

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).

Drug: Clobex® Vehicle Shampoo

Interventions

Clobex® Shampoo DRUG

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

Also known as: Clobetasol Propionate 0.05% [weight by weight (W/W)]

Initial Phase:- Clobex® Shampoo

Clobex® Vehicle Shampoo DRUG

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

Maintenance Phase: Clobex® Vehicle Shampoo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Galderma R&D: lead

Study Sites (1)

centre de Recherche Dermatologique du Québec

Québec, Canada

Location

Related Links

• Related Info

MeSH Terms

Interventions

Clobetasol

Intervention Hierarchy (Ancestors)

Betamethasone; Steroids, Fluorinated; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Results Point of Contact

• Title: Clinical Operations
• Organization: Galderma

Clinical.Studies@galderma.com

817 961 5000

Study Officials

• Poulin, MD

  Centre de Recherche Dermatologique du Quebec Métropolitain

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 16, 2006
• First Posted: November 17, 2006
• Study Start: September 29, 2006
• Primary Completion: August 20, 2007
• Study Completion: August 20, 2007
• Last Updated: July 11, 2023
• Results First Posted: July 11, 2023

Record last verified: 2022-08

Locations

CA (1)