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Subject Preference for Scalp Psoriasis Treatment

Primary Purpose

Scalp Psoriasis

Status
Completed
Phase
Phase 3
Locations
Italy
Study Type
Interventional
Intervention
C. propionate - Corticosteroid 1
C. propionate- Corticosteroid 2
C. propionate -Corticosteroid 3
Corticosteroid 1- C. propionate
Corticosteroid 2 - C. propionate
Corticosteroid 3 - C. propionate
Sponsored by
Galderma R&D
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Scalp Psoriasis focused on measuring 1 Galderma,, 2 Scalp Psoriasis, 3 Subject preference, 4 Clobetasol propionate, 5 Shampoo

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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).

Sites / Locations

  • Clinica Dermatologica Azienda Ospedaliera Policlinico di Modena

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Arm Label

C. propionate-Wash out-Corticosteroid 1

C. propionate-Wash out-Corticosteroid 2

C. propionate-Wash out-Corticosteroid 3

Corticosteroid 1-Wash out-C. propionate

Corticosteroid 2-Wash out-C. propionate

Corticosteroid 3-Wash out-C. propionate

Arm Description

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

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

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

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

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
February 21, 2007
Last Updated
February 16, 2021
Sponsor
Galderma R&D
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1. Study Identification

Unique Protocol Identification Number
NCT00438399
Brief Title
Subject Preference for Scalp Psoriasis Treatment
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
Study Type
Interventional

2. Study Status

Record Verification Date
November 2011
Overall Recruitment Status
Completed
Study Start Date
February 2007 (undefined)
Primary Completion Date
January 2008 (Actual)
Study Completion Date
February 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Galderma R&D

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Scalp Psoriasis
Keywords
1 Galderma,, 2 Scalp Psoriasis, 3 Subject preference, 4 Clobetasol propionate, 5 Shampoo

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Crossover Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
219 (Actual)

8. Arms, Groups, and Interventions

Arm Title
C. propionate-Wash out-Corticosteroid 1
Arm Type
Active Comparator
Arm Description
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
Arm Title
C. propionate-Wash out-Corticosteroid 2
Arm Type
Active Comparator
Arm Description
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
Arm Title
C. propionate-Wash out-Corticosteroid 3
Arm Type
Active Comparator
Arm Description
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
Arm Title
Corticosteroid 1-Wash out-C. propionate
Arm Type
Active Comparator
Arm Description
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
Arm Title
Corticosteroid 2-Wash out-C. propionate
Arm Type
Active Comparator
Arm Description
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
Arm Title
Corticosteroid 3-Wash out-C. propionate
Arm Type
Active Comparator
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
C. propionate - Corticosteroid 1
Other Intervention Name(s)
CP shampoo compared to Corticosteroid 1
Intervention Description
Twice daily application
Intervention Type
Drug
Intervention Name(s)
C. propionate- Corticosteroid 2
Other Intervention Name(s)
CP Shampoo compared to Corticosteroid 2
Intervention Description
Twice daily application
Intervention Type
Drug
Intervention Name(s)
C. propionate -Corticosteroid 3
Other Intervention Name(s)
CP Shampoo compared to Corticosteroid 3
Intervention Description
Twice daily application
Intervention Type
Drug
Intervention Name(s)
Corticosteroid 1- C. propionate
Other Intervention Name(s)
Corticosteroid 1 compared to CP Shampoo
Intervention Description
Twice daily application
Intervention Type
Drug
Intervention Name(s)
Corticosteroid 2 - C. propionate
Other Intervention Name(s)
Corticosteroid 2 compared to CP Shampoo
Intervention Description
Twice daily application
Intervention Type
Drug
Intervention Name(s)
Corticosteroid 3 - C. propionate
Other Intervention Name(s)
Corticosteroid 3 compared to CP Shampoo
Intervention Description
Twice daily application
Primary Outcome Measure Information:
Title
Percentage of Subjects Preffering Clobetasol Propionate Shampoo Better Than Comparator
Description
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.
Time Frame
End of period II (up to 16 weeks)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alberto Giannetti, Professor
Organizational Affiliation
Clinica Dermatologica Azienda Ospedaliera Policinico di Modena - Italy
Official's Role
Principal Investigator
Facility Information:
Facility Name
Clinica Dermatologica Azienda Ospedaliera Policlinico di Modena
City
Modena
ZIP/Postal Code
41100
Country
Italy

12. IPD Sharing Statement

Links:
URL
http://www.clobex.com/
Description
Study product information

Learn more about this trial

Subject Preference for Scalp Psoriasis Treatment

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