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

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%

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

Study Overview

• Status: Completed
• Conditions: Scalp Psoriasis
• Intervention / Treatment: Drug: Clobex® Shampoo; Drug: Clobex® Shampoo; Drug: Clobex® Vehicle Shampoo

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.

• Study Type: Interventional
• Enrollment (Actual): 288
• Phase: Phase 3

Contacts and Locations

Study Locations

• Canada
  • Quebec, Canada
    • centre de Recherche Dermatologique du Québec

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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]).	Drug: Clobex® Shampoo; Clobex® Shampoo 0.05 % (W/W) topically to scalp for 4 weeks.; Other Names: Clobetasol Propionate 0.05% [weight by weight (W/W)]; Drug: Clobex® Shampoo; Clobex® Shampoo 0.05% (W/W) topically to scalp up to 6 months.; Other Names: Clobetasol Propionate 0.05% (W/W)
Experimental: 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).	Drug: Clobex® Shampoo; Clobex® Shampoo 0.05 % (W/W) topically to scalp for 4 weeks.; Other Names: Clobetasol Propionate 0.05% [weight by weight (W/W)]; Drug: Clobex® Shampoo; Clobex® Shampoo 0.05% (W/W) topically to scalp up to 6 months.; Other Names: Clobetasol Propionate 0.05% (W/W)
Placebo Comparator: 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).	Drug: Clobex® Vehicle Shampoo; Clobex® Vehicle Shampoo 0.05 % (W/W) topically to scalp up to 6 months.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Initial Phase: Percentage of Participants With Global Severity Scores	Global severity score was evaluated on a scale of 0-4 and it was categorized as; Clear (score 0); no clinical signs or symptoms detected (hyperpigmentation or residual red coloration might be present), very mild (score 1); only very slight signs or symptoms detected (e.g., very fine scaling or slight erythema), mild (score 2); slight signs or symptoms detected (e.g., mild erythema and scaling, eventually associated to some barely detectable plaque elevation), moderate (score 3); moderate or clearly detectable signs or symptoms (e.g., definite redness with obvious scaling on a plaque that was elevated above skin level), severe (score 4); severe signs or symptoms detected (e.g., intense redness, profuse shedding, definite plaque thickness was most often present) where 0 indicates best and 4 indicates worst. Percentage of participants with GSS was reported. Missing Clobex® shampoo data were imputed using last observation carried forward (LOCF).	Baseline, Weeks 2 and 4 LOCF
Initial Phase: Percentage of Participants With Pruritus Scores	Pruritus (itching sensation) score of were evaluated on a scale from 0 - 3 (0 = None [no itching], 1 = Mild [slight itching], not really bothersome), 2 = Moderate [definite itching that is somewhat bothersome; without loss of sleep], and 3 = severe [intense itching that has caused pronounced discomfort; night rest interrupted and excoriations of the skin from scratching may be present]) , where 0 indicates best and 3 indicates worst. Percentage of participants with pruritus score was reported. Missing Clobex® shampoo data were imputed using last observation carried forward (LOCF).	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	Individual sign scores of erythema (abnormal redness of skin), scaling (scales attached to the scalp), plaque thickening (a thickening or elevation of a circumscribed lesion or plaque) were evaluated on a scale of 0-4; 0= none , 1= mild , 2=moderate , 3= severe, 4= very severe, where 0 indicates best and 4 indicates worst. Percentage of participants with individual signs (erythema, scaling, and plaque thickening) scores were reported. Missing Clobex® shampoo data were imputed using last observation carried forward (LOCF).	Baseline, Weeks 2 and 4 LOCF
Maintenance Phase: Percentage of Participants Who Had First Relapse	The first relapse was defined as the first time during the maintenance phase when participant presented with a GSS >2. Relapse was categorized into relapse or no relapse. Percentage of participants with relapse were reported.	Baseline, Weeks 4, 8, 12, 16, 20, and 24
Maintenance Phase: Percentage of Participants With Scalp Psoriasis Pruritus Score at First Time of Relapse	Pruritus (itching sensation) score of were evaluated on a scale from 0 - 3 (0 = None [no itching], 1 = Mild [slight itching, not really bothersome], 2 = Moderate [definite itching that is somewhat bothersome; without loss of sleep], and 3 = severe [intense itching that has caused pronounced discomfort; night rest interrupted and excoriations of the skin from scratching may be present]) , where 0 indicates best and 3 indicates worst. Percentage of participants with scalp psoriasis pruritus score at first relapse was reported.	Baseline up to Week 24
Maintenance Phase: Percentage of Participants With Individual Category of Scalp Psoriasis Individual Signs (Erythema, Scaling and Plaque Thickening) Scores at First Time of Relapse	The first relapse was defined as the first time during the maintenance phase when participant presented with a GSS >2. Individual sign scores of erythema were evaluated on a scale of 0-4 (0= none, 1= mild, 2=moderate, 3= severe, 4= very severe), where 0 indicates best and 4 indicates worst. Percentage of participants with individual signs (erythema, scaling and plaque thickening) scores were reported. There were no participants in scaling category with 0 score.	Baseline up to Week 24
Maintenance Phase: Percentage of Participants With Number of Relapses Experienced	Number of relapses of participants were categorized as 0; zero relapse, 1; one relapse, 2; two relapse, 3; three relapse, 4; two consecutive relapses. Percentage of participants with total number of relapses experienced during maintenance period was reported.	Baseline up to Week 28

Collaborators and Investigators

• Sponsor: Galderma R&D
• Investigators: Principal Investigator: Poulin, MD, Centre de Recherche Dermatologique Du Quebec Metropolitain

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start (Actual): September 29, 2006
• Primary Completion (Actual): August 20, 2007
• Study Completion (Actual): August 20, 2007

Study Registration Dates

• First Submitted: November 16, 2006
• First Submitted That Met QC Criteria: November 16, 2006
• First Posted (Estimated): November 17, 2006

Study Record Updates

• Last Update Posted (Actual): July 11, 2023
• Last Update Submitted That Met QC Criteria: August 8, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Keywords: maintenance; Galderma; scalp psoriasis
• Additional Relevant MeSH Terms: Skin Diseases; Skin Diseases, Papulosquamous; Psoriasis; Physiological Effects of Drugs; Anti-Inflammatory Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Clobetasol
• Other Study ID Numbers: RD.03.SPR.29060