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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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%

Conditions
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Scalp Psoriasis

Intervention / Treatment
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* Drug: Clobex® Shampoo
* Drug: Clobex® Vehicle Shampoo
* Drug: Clobex® Shampoo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Initial Phase:- Clobex® Shampoo<br>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<br>* Clobex® Shampoo 0.05 % (W/W) topically to scalp for 4 weeks.<br>* Other names: Clobetasol Propionate 0.05% [weight by weight (W/W)];|
| Experimental: Maintenance Phase: Clobex® Shampoo<br>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<br>* Clobex® Shampoo 0.05% (W/W) topically to scalp up to 6 months.<br>* Other names: Clobetasol Propionate 0.05% (W/W);|
| Placebo Comparator: Maintenance Phase: Clobex® Vehicle Shampoo<br>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<br>* Clobex® Vehicle Shampoo 0.05 % (W/W) topically to scalp up to 6 months.<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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maintenance, scalp psoriasis, Galderma