Scalp PsoriasisPhase 3NCT00438399
Subject Preference for Scalp Psoriasis Treatment
A Phase 3 study testing C. propionate - Corticosteroid 1, C. propionate- Corticosteroid 2 and C. propionate -Corticosteroid 3 in people with Scalp Psoriasis, run by Galderma R&D at 1 site in Italy.
Trial summary
The scalp is one of the most common affected sites in psoriatic patients as 79% of them have scalp involvement.It has also a psychological aspect with 31% of patients with scalp psoriasis indicating distress. Topical agents remain the mainstay of treatment for scalp psoriasis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Scalp Psoriasis
- What is being tested?
- C. propionate - Corticosteroid 1, C. propionate- Corticosteroid 2 and C. propionate -Corticosteroid 3
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 219 participants
- Where
- 1 siteItaly
- Study dates
- Feb 2007to Feb 2008
- 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, 18 years of age or older,
- Subjects with moderate to severe scalp psoriasis,
- Subjects who signed written informed consent prior to any study procedures.
Who cannot join
- Subjects who need systemic treatment for their body psoriasis,
- Subjects who are at risk in terms of precautions, warnings and contra-indication,
- Female subjects who are pregnant, nursing or planning a pregnancy during the study,
- Subjects with a specific washout period for topical treatment(s) on the scalp,
- Subjects with a specific washout period for systemic treatment(s).
Trial locations and contacts
1 site in 1 country.
Italy1 site
Clinica Dermatologica Azienda Ospedaliera Policlinico di Modena
Modena, 41100
About this study
Official title: Subject Preference Comparison Between Clobetasol Propionate Shampoo, 0.05% and Three Other Topical Corticosteroids in the Treatment of Moderate to Severe Scalp Psoriasis
The scalp is one of the most common affected sites in psoriatic patients as 79% of them have scalp involvement.It has also a psychological aspect with 31% of patients with scalp psoriasis indicating distress.
Topical agents remain the mainstay of treatment for scalp psoriasis. However, they are not always ideal because they might be inconvenient and messy to use, stain or damage hair.
Read more
The test shampoo, Clobetasol propionate Shampoo 0.05% (marketed in the USA under the tradename of Clobex®) was developed to provide the strongest available corticosteroid as a short-contact therapy in order to improve the chances of it being effective and reduce the potential for traditional side-effects.
The objective of this study is to compare subject's overall preference between Clobetasol propionate shampoo 0.05% and three other topical corticosteroids in the treatment of moderate to severe scalp psoriasis.
Read the detailed description
This study will be a multi-centre, investigator blinded, randomized, cross-over, intra-individual comparison in three parallel groups.
In each parallel group, Clobetasol propionate shampoo, 0.05% will be compared to one of the three chosen competitors, following a cross-over design.
- Conditions
- Scalp Psoriasis
- Being tested
- C. propionate - Corticosteroid 1, C. propionate- Corticosteroid 2, C. propionate -Corticosteroid 3, Corticosteroid 1- C. propionate, Corticosteroid 2 - C. propionate
- Keywords
- 1 Galderma,, 2 Scalp Psoriasis, 3 Subject preference, 4 Clobetasol propionate, 5 Shampoo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
C. propionate - Corticosteroid 1Drug
Also called CP shampoo compared to Corticosteroid 1
Twice daily application
C. propionate- Corticosteroid 2Drug
Also called CP Shampoo compared to Corticosteroid 2
Twice daily application
C. propionate -Corticosteroid 3Drug
Also called CP Shampoo compared to Corticosteroid 3
Twice daily application
Corticosteroid 1- C. propionateDrug
Also called Corticosteroid 1 compared to CP Shampoo
Twice daily application
Corticosteroid 2 - C. propionateDrug
Also called Corticosteroid 2 compared to CP Shampoo
Twice daily application
Corticosteroid 3 - C. propionateDrug
Also called Corticosteroid 3 compared to CP Shampoo
Twice daily application
| Study group | Role | What they receive |
|---|---|---|
| C. propionate-Wash out-Corticosteroid 1 | Active comparator | Clobetasol propionate Shampoo:
* Dose or Concentration: Clobetasol propionate 0.05% shampoo
* Mode and Frequency of Administration: Topical Once daily to the dry scalp, to be lathered and rinsed after 15 minutes
* Duration of Treatment: 4 weeks as a maximum
Wash-out up to 8 weeks
Corticosteroid 1:
* Dose or Concentration: Corticosteroid 1 Foam
* Mode and Frequency of Administration:Twice daily, a "golf-ball" sized amount to be massaged into the affected area of the scalp
* Duration of Treatment: 4 weeks as a maximum Receives: Drug: C. propionate - Corticosteroid 1 |
| C. propionate-Wash out-Corticosteroid 2 | Active comparator | Clobetasol propionate Shampoo:
* Dose or Concentration: Clobetasol propionate 0.05% shampoo
* Mode and Frequency of Administration: Topical Once daily to the dry scalp, to be lathered and rinsed after 15 minutes
* Duration of Treatment: 4 weeks as a maximum
Corticosteroid 2:
* Dose or Concentration: Corticosteroid 2 Lotion
* Mode and Frequency of Administration: Twice daily, a thin film to be applied to the affected area of the scalp and massaged gently and thoroughly into the skin
* Duration of Treatment: 4 weeks as a maximum Receives: Drug: C. propionate- Corticosteroid 2 |
| C. propionate-Wash out-Corticosteroid 3 | Active comparator | Clobetasol propionate Shampoo:
* Dose or Concentration: Clobetasol propionate 0.05% shampoo
* Mode and Frequency of Administration: Topical Once daily to the dry scalp, to be lathered and rinsed after 15 minutes
* Duration of Treatment: 4 weeks as a maximum
Corticosteroid 3:
* Dose or Concentration: Corticosteroid 3 Scalp application
* Mode and Frequency of Administration: Twice daily, a thin film to be applied into the affected area of the dry scalp and rubbed gently into the scalp
* Duration of Treatment: 4 weeks as a maximum Receives: Drug: C. propionate -Corticosteroid 3 |
| Corticosteroid 1-Wash out-C. propionate | Active comparator | Clobetasol propionate Shampoo:
* Dose or Concentration: Clobetasol propionate 0.05% shampoo
* Mode and Frequency of Administration: Topical Once daily to the dry scalp, to be lathered and rinsed after 15 minutes
* Duration of Treatment: 4 weeks as a maximum
Corticosteroid 1:
* Dose or Concentration: Corticosteroid 1 Foam
* Mode and Frequency of Administration:Twice daily, a "golf-ball" sized amount to be massaged into the affected area of the scalp
* Duration of Treatment: 4 weeks as a maximum Receives: Drug: Corticosteroid 1- C. propionate |
| Corticosteroid 2-Wash out-C. propionate | Active comparator | Clobetasol propionate Shampoo:
* Dose or Concentration: Clobetasol propionate 0.05% shampoo
* Mode and Frequency of Administration: Topical Once daily to the dry scalp, to be lathered and rinsed after 15 minutes
* Duration of Treatment: 4 weeks as a maximum
Corticosteroid 2:
* Dose or Concentration: Corticosteroid 2 Lotion
* Mode and Frequency of Administration: Twice daily, a thin film to be applied to the affected area of the scalp and massaged gently and thoroughly into the skin
* Duration of Treatment: 4 weeks as a maximum Receives: Drug: Corticosteroid 2 - C. propionate |
| Corticosteroid 3-Wash out-C. propionate | Active comparator | Clobetasol propionate Shampoo:
* Dose or Concentration: Clobetasol propionate 0.05% shampoo
* Mode and Frequency of Administration: Topical Once daily to the dry scalp, to be lathered and rinsed after 15 minutes
* Duration of Treatment: 4 weeks as a maximum
Corticosteroid 3:
* Dose or Concentration: Corticosteroid 3 Scalp application
* Mode and Frequency of Administration: Twice daily, a thin film to be applied into the affected area of the dry scalp and rubbed gently into the scalp
* Duration of Treatment: 4 weeks as a maximum Receives: Drug: Corticosteroid 3 - C. propionate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Subjects Preffering Clobetasol Propionate Shampoo Better Than Comparator
Subjects' Overall preference at the end of Period II. The purpose was to demonstrate a superiority of Clobetasol propionate shampoo 0.05% therapy compared to any of three other topical comparators, in terms of subject's overall preference: "C. propionate shampoo a lot better than the comparator",C. propionate shampoo a lillte bit better than the comparator", "Comparator a lot better than C. propionate shampoo", Comparator a lillte bit better than C. propionate shampoo". This was to be shown using a non parametric two-sided Wilcoxon rank Signed test, on Intention to Treat (ITT) population.
Measured: End of period II (up to 16 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2007 (estimated)
- Study startFeb 2007
- Primary completionJan 2008
- Study completionFeb 2008
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.
- 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
- Crossover
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 219 participants (actual)
Sponsor and investigators
- Lead sponsor
- Galderma R&D
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Alberto Giannetti, Professor, Principal investigator, Clinica Dermatologica Azienda Ospedaliera Policinico di Modena - Italy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00438399
- Sponsor's protocol ID
- RD.03.SPR.29064
- Other IDs
- 2006-003073-27
- Status last verified
- Nov 2011
- First submitted
- 21 Feb 2007
- Last updated
- 18 Feb 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Subject Preference Comparison Between Clobetasol Propionate Shampoo, 0.05% and Three Other Topical Corticosteroids in the Treatment of Moderate to Severe Scalp Psoriasis
- ClinicalTrials.gov ID
- NCT00438399
- Acronym / sponsor ID
- RD.03.SPR.29064
- Conditions
- Scalp Psoriasis
- Keywords
- 1 Galderma,, 2 Scalp Psoriasis, 3 Subject preference, 4 Clobetasol propionate, 5 Shampoo
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 219 participants (actual)
- Lead sponsor
- Galderma R&DIndustry (pharma, biotech, devices)
- Study start
- Feb 2007
- Primary completion
- Jan 2008 (actual)
- Study completion
- Feb 2008 (actual)
- First posted
- 22 Feb 2007 (estimated)
- Results
- Posted 23 Dec 2011
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The scalp is one of the most common affected sites in psoriatic patients as 79% of them have scalp involvement.It has also a psychological aspect with 31% of patients with scalp psoriasis indicating distress.
Topical agents remain the mainstay of treatment for scalp psoriasis. However, they are not always ideal because they might be inconvenient and messy to use, stain or damage hair.
The test shampoo, Clobetasol propionate Shampoo 0.05% (marketed in the USA under the tradename of Clobex®) was developed to provide the strongest available corticosteroid as a short-contact therapy in order to improve the chances of it being effective and reduce the potential for traditional side-effects.
The objective of this study is to compare subject's overall preference between Clobetasol propionate shampoo 0.05% and three other topical corticosteroids in the treatment of moderate to severe scalp psoriasis.
Detailed description
This study will be a multi-centre, investigator blinded, randomized, cross-over, intra-individual comparison in three parallel groups.
In each parallel group, Clobetasol propionate shampoo, 0.05% will be compared to one of the three chosen competitors, following a cross-over design.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (investigator)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| C. propionate-Wash out-Corticosteroid 1 | Active comparator | Drug: C. propionate - Corticosteroid 1Clobetasol propionate Shampoo: * Dose or Concentration: Clobetasol propionate 0.05% shampoo * Mode and Frequency of Administration: Topical Once daily to the dry scalp, to be lathered and rinsed after 15 minutes * Duration of Treatment: 4 weeks as a maximum Wash-out up to 8 weeks Corticosteroid 1: * Dose or Concentration: Corticosteroid 1 Foam * Mode and Frequency of Administration:Twice daily, a "golf-ball" sized amount to be massaged into the affected area of the scalp * Duration of Treatment: 4 weeks as a maximum |
| C. propionate-Wash out-Corticosteroid 2 | Active comparator | Drug: C. propionate- Corticosteroid 2Clobetasol propionate Shampoo: * Dose or Concentration: Clobetasol propionate 0.05% shampoo * Mode and Frequency of Administration: Topical Once daily to the dry scalp, to be lathered and rinsed after 15 minutes * Duration of Treatment: 4 weeks as a maximum Corticosteroid 2: * Dose or Concentration: Corticosteroid 2 Lotion * Mode and Frequency of Administration: Twice daily, a thin film to be applied to the affected area of the scalp and massaged gently and thoroughly into the skin * Duration of Treatment: 4 weeks as a maximum |
| C. propionate-Wash out-Corticosteroid 3 | Active comparator | Drug: C. propionate -Corticosteroid 3Clobetasol propionate Shampoo: * Dose or Concentration: Clobetasol propionate 0.05% shampoo * Mode and Frequency of Administration: Topical Once daily to the dry scalp, to be lathered and rinsed after 15 minutes * Duration of Treatment: 4 weeks as a maximum Corticosteroid 3: * Dose or Concentration: Corticosteroid 3 Scalp application * Mode and Frequency of Administration: Twice daily, a thin film to be applied into the affected area of the dry scalp and rubbed gently into the scalp * Duration of Treatment: 4 weeks as a maximum |
| Corticosteroid 1-Wash out-C. propionate | Active comparator | Drug: Corticosteroid 1- C. propionateClobetasol propionate Shampoo: * Dose or Concentration: Clobetasol propionate 0.05% shampoo * Mode and Frequency of Administration: Topical Once daily to the dry scalp, to be lathered and rinsed after 15 minutes * Duration of Treatment: 4 weeks as a maximum Corticosteroid 1: * Dose or Concentration: Corticosteroid 1 Foam * Mode and Frequency of Administration:Twice daily, a "golf-ball" sized amount to be massaged into the affected area of the scalp * Duration of Treatment: 4 weeks as a maximum |
| Corticosteroid 2-Wash out-C. propionate | Active comparator | Drug: Corticosteroid 2 - C. propionateClobetasol propionate Shampoo: * Dose or Concentration: Clobetasol propionate 0.05% shampoo * Mode and Frequency of Administration: Topical Once daily to the dry scalp, to be lathered and rinsed after 15 minutes * Duration of Treatment: 4 weeks as a maximum Corticosteroid 2: * Dose or Concentration: Corticosteroid 2 Lotion * Mode and Frequency of Administration: Twice daily, a thin film to be applied to the affected area of the scalp and massaged gently and thoroughly into the skin * Duration of Treatment: 4 weeks as a maximum |
| Corticosteroid 3-Wash out-C. propionate | Active comparator | Drug: Corticosteroid 3 - C. propionateClobetasol propionate Shampoo: * Dose or Concentration: Clobetasol propionate 0.05% shampoo * Mode and Frequency of Administration: Topical Once daily to the dry scalp, to be lathered and rinsed after 15 minutes * Duration of Treatment: 4 weeks as a maximum Corticosteroid 3: * Dose or Concentration: Corticosteroid 3 Scalp application * Mode and Frequency of Administration: Twice daily, a thin film to be applied into the affected area of the dry scalp and rubbed gently into the scalp * Duration of Treatment: 4 weeks as a maximum |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Male or female subjects, 18 years of age or older,
- Subjects with moderate to severe scalp psoriasis,
- Subjects who signed written informed consent prior to any study procedures.
Key exclusion criteria (5 listed)
- Subjects who need systemic treatment for their body psoriasis,
- Subjects who are at risk in terms of precautions, warnings and contra-indication,
- Female subjects who are pregnant, nursing or planning a pregnancy during the study,
- Subjects with a specific washout period for topical treatment(s) on the scalp,
- Subjects with a specific washout period for systemic treatment(s).
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 |
|---|---|---|
| C. propionate - Corticosteroid 1Also: CP shampoo compared to Corticosteroid 1Twice daily application | Drug | C. propionate-Wash out-Corticosteroid 1 |
| C. propionate- Corticosteroid 2Also: CP Shampoo compared to Corticosteroid 2Twice daily application | Drug | C. propionate-Wash out-Corticosteroid 2 |
| C. propionate -Corticosteroid 3Also: CP Shampoo compared to Corticosteroid 3Twice daily application | Drug | C. propionate-Wash out-Corticosteroid 3 |
| Corticosteroid 1- C. propionateAlso: Corticosteroid 1 compared to CP ShampooTwice daily application | Drug | Corticosteroid 1-Wash out-C. propionate |
| Corticosteroid 2 - C. propionateAlso: Corticosteroid 2 compared to CP ShampooTwice daily application | Drug | Corticosteroid 2-Wash out-C. propionate |
| Corticosteroid 3 - C. propionateAlso: Corticosteroid 3 compared to CP ShampooTwice daily application | Drug | Corticosteroid 3-Wash out-C. propionate |
Primary outcome
Percentage of Subjects Preffering Clobetasol Propionate Shampoo Better Than Comparator
Time frame: End of period II (up to 16 weeks)
Subjects' Overall preference at the end of Period II. The purpose was to demonstrate a superiority of Clobetasol propionate shampoo 0.05% therapy compared to any of three other topical comparators, in terms of subject's overall preference: "C. propionate shampoo a lot better than the comparator",C. propionate shampoo a lillte bit better than the comparator", "Comparator a lot better than C. propionate shampoo", Comparator a lillte bit better than C. propionate shampoo". This was to be shown using a non parametric two-sided Wilcoxon rank Signed test, on Intention to Treat (ITT) population.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Study product informationLink 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.
Alberto Giannetti, Professor principal investigator
Clinica Dermatologica Azienda Ospedaliera Policinico di Modena - Italy
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 testing C. propionate - Corticosteroid 1, C. propionate- Corticosteroid 2 and C. propionate -Corticosteroid 3 in people with Scalp Psoriasis, run by Galderma R&D at 1 site in Italy.
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 3 inclusion and 5 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 18 Feb 2021. 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 Italy. 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. 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 23 Dec 2011). 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?
Percentage of Subjects Preffering Clobetasol Propionate Shampoo Better Than Comparator (time frame: End of period II (up to 16 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 18 Feb 2021.