Subject Preference for Scalp Psoriasis Treatment

February 16, 2021 updated by: Galderma R&D

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.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

219

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Modena, Italy, 41100
        • Clinica Dermatologica Azienda Ospedaliera Policlinico di Modena

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: C. propionate-Wash out-Corticosteroid 1

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
Twice daily application
Other Names:
  • CP shampoo compared to Corticosteroid 1
Active Comparator: C. propionate-Wash out-Corticosteroid 2

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
Twice daily application
Other Names:
  • CP Shampoo compared to Corticosteroid 2
Active Comparator: C. propionate-Wash out-Corticosteroid 3

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
Twice daily application
Other Names:
  • CP Shampoo compared to Corticosteroid 3
Active Comparator: Corticosteroid 1-Wash out-C. propionate

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
Twice daily application
Other Names:
  • Corticosteroid 1 compared to CP Shampoo
Active Comparator: Corticosteroid 2-Wash out-C. propionate

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
Twice daily application
Other Names:
  • Corticosteroid 2 compared to CP Shampoo
Active Comparator: Corticosteroid 3-Wash out-C. propionate

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
Twice daily application
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
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.
End of period II (up to 16 weeks)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Galderma R&D

Investigators

  • Principal Investigator: Alberto Giannetti, Professor, Clinica Dermatologica Azienda Ospedaliera Policinico di Modena - Italy

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2007

Primary Completion (Actual)

January 1, 2008

Study Completion (Actual)

February 1, 2008

Study Registration Dates

First Submitted

February 21, 2007

First Submitted That Met QC Criteria

February 21, 2007

First Posted (Estimate)

February 22, 2007

Study Record Updates

Last Update Posted (Actual)

February 18, 2021

Last Update Submitted That Met QC Criteria

February 16, 2021

Last Verified

November 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RD.03.SPR.29064
  • 2006-003073-27 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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