Scalp PsoriasisPhase 3NCT00400725
Maintenance Effect of Clobex Shampoo on Participants With Moderate to Severe Scalp Psoriasis
A Phase 3 study of Scalp Psoriasis, run by Galderma R&D at 1 site in Canada.
Trial summary
The objective of the study was to assess the maintenance effect on scalp psoriasis of Clobex® Shampoo 0.05% when used twice weekly. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Scalp Psoriasis
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 288 participants
- Where
- 1 siteCanada
- Study dates
- 29 Sep 2006to 20 Aug 2007
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female subjects aged 18 years or older.
- Subjects with moderate to severe scalp psoriasis
Who cannot join
- 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
Show all 9Show fewer
- Biological therapies 12 weeks
- Treatments other than biologicals with a possible efficacy on psoriasis 4 weeks
- Treatment known to worsen psoriasis 2 weeks
Trial locations and contacts
1 site in 1 country.
About this study
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%
The objective of the study was to assess the maintenance effect on scalp psoriasis of Clobex® Shampoo 0.05% when used twice weekly.
Read the 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
- Being tested
- Clobex® Shampoo, Clobex® Vehicle Shampoo
- Keywords
- maintenance, scalp psoriasis, Galderma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clobex® ShampooDrug
Also called Clobetasol Propionate 0.05% [weight by weight (W/W)]
Clobex® Shampoo 0.05 % (W/W) topically to scalp for 4 weeks.
Clobex® Vehicle ShampooDrug
Clobex® Vehicle Shampoo 0.05 % (W/W) topically to scalp up to 6 months.
Clobex® ShampooDrug
Also called Clobetasol Propionate 0.05% (W/W)
Clobex® Shampoo 0.05% (W/W) topically to scalp up to 6 months.
| Study group | Role | What they receive |
|---|---|---|
| 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]). Receives: 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). Receives: 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). Receives: Drug: Clobex® Vehicle Shampoo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline up to 24 Weeks
Secondary outcomes (7)
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).
Measured: 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).
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline up to Week 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2006 (estimated)
- Study start29 Sep 2006
- Primary completion20 Aug 2007
- Study completion20 Aug 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Scalp PsoriasisStudies of the same condition, open and under way.
- More trials run by Galderma R&DThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 288 participants (actual)
Sponsor and investigators
- Lead sponsor
- Galderma R&D
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Poulin, MD, Principal investigator, Centre de Recherche Dermatologique du Quebec Métropolitain
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00400725
- Sponsor's protocol ID
- RD.03.SPR.29060
- Status last verified
- Aug 2022
- First submitted
- 16 Nov 2006
- Last updated
- 11 Jul 2023
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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%
- ClinicalTrials.gov ID
- NCT00400725
- Acronym / sponsor ID
- RD.03.SPR.29060
- Conditions
- Scalp Psoriasis
- Keywords
- maintenance, scalp psoriasis, Galderma
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 288 participants (actual)
- Lead sponsor
- Galderma R&DIndustry (pharma, biotech, devices)
- Study start
- 29 Sep 2006 (actual)
- Primary completion
- 20 Aug 2007 (actual)
- Study completion
- 20 Aug 2007 (actual)
- First posted
- 17 Nov 2006 (estimated)
- Results
- Posted 11 Jul 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Initial Phase:- Clobex® Shampoo | Experimental | Drug: Clobex® ShampooIn 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]). |
| Maintenance Phase: Clobex® Shampoo | Experimental | Drug: Clobex® ShampooIn 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). |
| Maintenance Phase: Clobex® Vehicle Shampoo | Placebo comparator | Drug: Clobex® Vehicle ShampooIn 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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Male or female subjects aged 18 years or older.
- Subjects with moderate to severe scalp psoriasis
Key exclusion criteria (9 listed)
- Subjects who needed systemic treatment for their body psoriasis
- Subjects with a washout period for topical treatment(s) on the scalp less than:
- Subjects with a washout period for systemic treatment(s) less than:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Clobex® ShampooAlso: Clobetasol Propionate 0.05% [weight by weight (W/W)]Clobex® Shampoo 0.05 % (W/W) topically to scalp for 4 weeks. | Drug | Initial Phase:- Clobex® Shampoo |
| Clobex® Vehicle ShampooClobex® Vehicle Shampoo 0.05 % (W/W) topically to scalp up to 6 months. | Drug | Maintenance Phase: Clobex® Vehicle Shampoo |
| Clobex® ShampooAlso: Clobetasol Propionate 0.05% (W/W)Clobex® Shampoo 0.05% (W/W) topically to scalp up to 6 months. | Drug | Maintenance Phase: Clobex® Shampoo |
Primary outcome
Maintenance Phase: Time to First Relapse
Time frame: Baseline up to 24 Weeks
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.
7 secondary outcomes
Initial Phase: Percentage of Participants With Global Severity Scores
Time frame: Baseline, Weeks 2 and 4 LOCF
Initial Phase: Percentage of Participants With Pruritus Scores
Time frame: 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
Time frame: Baseline, Weeks 2 and 4 LOCF
Maintenance Phase: Percentage of Participants Who Had First Relapse
Time frame: Baseline, Weeks 4, 8, 12, 16, 20, and 24
Maintenance Phase: Percentage of Participants With Scalp Psoriasis Pruritus Score at First Time of Relapse
Time frame: 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
Time frame: Baseline up to Week 24
Maintenance Phase: Percentage of Participants With Number of Relapses Experienced
Time frame: Baseline up to Week 28
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Related InfoLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Poulin, MD principal investigator
Centre de Recherche Dermatologique du Quebec Métropolitain
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study of Scalp Psoriasis, run by Galderma R&D at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 11 Jul 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maintenance Phase: Time to First Relapse (time frame: Baseline up to 24 Weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jul 2023.