Subject Preference for Scalp Psoriasis Treatment

Study Overview
=================
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.

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

Conditions
-----------------
Scalp Psoriasis

Intervention / Treatment
-----------------
* Drug: C. propionate - Corticosteroid 1
* Drug: C. propionate- Corticosteroid 2
* Drug: C. propionate -Corticosteroid 3
* Drug: Corticosteroid 1- C. propionate
* Drug: Corticosteroid 2 - C. propionate
* Drug: Corticosteroid 3 - C. propionate


Participation Criteria
=================
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).

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: C. propionate-Wash out-Corticosteroid 1<br>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 | Drug: C. propionate - Corticosteroid 1<br>* Twice daily application<br>* Other names: CP shampoo compared to Corticosteroid 1;|
| Active Comparator: C. propionate-Wash out-Corticosteroid 2<br>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 | Drug: C. propionate- Corticosteroid 2<br>* Twice daily application<br>* Other names: CP Shampoo compared to Corticosteroid 2;|
| Active Comparator: C. propionate-Wash out-Corticosteroid 3<br>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 | Drug: C. propionate -Corticosteroid 3<br>* Twice daily application<br>* Other names: CP Shampoo compared to Corticosteroid 3;|
| Active Comparator: Corticosteroid 1-Wash out-C. propionate<br>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 | Drug: Corticosteroid 1- C. propionate<br>* Twice daily application<br>* Other names: Corticosteroid 1 compared to CP Shampoo;|
| Active Comparator: Corticosteroid 2-Wash out-C. propionate<br>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 | Drug: Corticosteroid 2 - C. propionate<br>* Twice daily application<br>* Other names: Corticosteroid 2 compared to CP Shampoo;|
| Active Comparator: Corticosteroid 3-Wash out-C. propionate<br>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 | Drug: Corticosteroid 3 - C. propionate<br>* Twice daily application<br>* Other names: Corticosteroid 3 compared to CP Shampoo;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | End of period II (up to 16 weeks) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
1 Galderma,, 2 Scalp Psoriasis, 3 Subject preference, 4 Clobetasol propionate, 5 Shampoo