Back to resultsMaintenance Effect of Clobex Shampoo on Participants With Moderate to Severe Scalp Psoriasis
Primary Purpose
Scalp Psoriasis
Status
Completed
Phase
Phase 3
Locations
Canada
Study Type
Interventional
Intervention
Clobex® Shampoo
Clobex® Vehicle Shampoo
Clobex® Shampoo
Sponsored by
About this trial
This is an interventional treatment trial for Scalp Psoriasis focused on measuring maintenance, scalp psoriasis, Galderma
Eligibility Criteria
Inclusion Criteria:
- Male or female subjects aged 18 years or older.
- Subjects with moderate to severe scalp psoriasis
Exclusion Criteria:
- Subjects who need 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
Sites / Locations
- centre de Recherche Dermatologique du Québec
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Placebo Comparator
Arm Label
Initial Phase:- Clobex® Shampoo
Maintenance Phase: Clobex® Shampoo
Maintenance Phase: Clobex® Vehicle Shampoo
Arm Description
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]).
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).
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).
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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).
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).
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).
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.
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.
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.
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00400725
Brief Title
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
2. Study Status
Record Verification Date
August 2022
Overall Recruitment Status
Completed
Study Start Date
September 29, 2006 (Actual)
Primary Completion Date
August 20, 2007 (Actual)
Study Completion Date
August 20, 2007 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Galderma R&D
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Scalp Psoriasis
Keywords
maintenance, scalp psoriasis, Galderma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
288 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Initial Phase:- Clobex® Shampoo
Arm Type
Experimental
Arm Description
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]).
Arm Title
Maintenance Phase: Clobex® Shampoo
Arm Type
Experimental
Arm Description
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).
Arm Title
Maintenance Phase: Clobex® Vehicle Shampoo
Arm Type
Placebo Comparator
Arm Description
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).
Intervention Type
Drug
Intervention Name(s)
Clobex® Shampoo
Other Intervention Name(s)
Clobetasol Propionate 0.05% [weight by weight (W/W)]
Intervention Description
Clobex® Shampoo 0.05 % (W/W) topically to scalp for 4 weeks.
Intervention Type
Drug
Intervention Name(s)
Clobex® Vehicle Shampoo
Intervention Description
Clobex® Vehicle Shampoo 0.05 % (W/W) topically to scalp up to 6 months.
Intervention Type
Drug
Intervention Name(s)
Clobex® Shampoo
Other Intervention Name(s)
Clobetasol Propionate 0.05% (W/W)
Intervention Description
Clobex® Shampoo 0.05% (W/W) topically to scalp up to 6 months.
Primary Outcome Measure Information:
Title
Maintenance Phase: Time to First Relapse
Description
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.
Time Frame
Baseline up to 24 Weeks
Secondary Outcome Measure Information:
Title
Initial Phase: Percentage of Participants With Global Severity Scores
Description
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).
Time Frame
Baseline, Weeks 2 and 4 LOCF
Title
Initial Phase: Percentage of Participants With Pruritus Scores
Description
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).
Time Frame
Baseline, Weeks 2 and 4 LOCF
Title
Initial Phase: Percentage of Participants With Individual Category of Scalp Psoriasis Individual Signs (Erythema, Scaling and Plaque Thickening) Scores
Description
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).
Time Frame
Baseline, Weeks 2 and 4 LOCF
Title
Maintenance Phase: Percentage of Participants Who Had First Relapse
Description
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.
Time Frame
Baseline, Weeks 4, 8, 12, 16, 20, and 24
Title
Maintenance Phase: Percentage of Participants With Scalp Psoriasis Pruritus Score at First Time of Relapse
Description
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.
Time Frame
Baseline up to Week 24
Title
Maintenance Phase: Percentage of Participants With Individual Category of Scalp Psoriasis Individual Signs (Erythema, Scaling and Plaque Thickening) Scores at First Time of Relapse
Description
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.
Time Frame
Baseline up to Week 24
Title
Maintenance Phase: Percentage of Participants With Number of Relapses Experienced
Description
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.
Time Frame
Baseline up to Week 28
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Poulin, MD
Organizational Affiliation
Centre de Recherche Dermatologique du Quebec Métropolitain
Official's Role
Principal Investigator
Facility Information:
Facility Name
centre de Recherche Dermatologique du Québec
City
Quebec
Country
Canada
12. IPD Sharing Statement
Links:
URL
http://www.clobex.com
Description
Related Info
Learn more about this trial
Maintenance Effect of Clobex Shampoo on Participants With Moderate to Severe Scalp Psoriasis
We'll reach out to this number within 24 hrs