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Completed

NCT Number: NCT00438399

Subject Preference for Scalp Psoriasis Treatment

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.

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Key information

Conditions

Scalp Psoriasis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Clinica Dermatologica Azienda Ospedaliera Policlinico di Modena

Modena, 41100, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

C. propionate - Corticosteroid 1

Drug

Twice daily application

Other names: CP shampoo compared to Corticosteroid 1

C. propionate- Corticosteroid 2

Drug

Twice daily application

Other names: CP Shampoo compared to Corticosteroid 2

C. propionate -Corticosteroid 3

Drug

Twice daily application

Other names: CP Shampoo compared to Corticosteroid 3

Corticosteroid 1- C. propionate

Drug

Twice daily application

Other names: Corticosteroid 1 compared to CP Shampoo

Corticosteroid 2 - C. propionate

Drug

Twice daily application

Other names: Corticosteroid 2 compared to CP Shampoo

Corticosteroid 3 - C. propionate

Drug

Twice daily application

Other names: Corticosteroid 3 compared to CP Shampoo

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Galderma R&D

Industry

Registry information

Official study title

Subject Preference Comparison Between Clobetasol Propionate Shampoo, 0.05% and Three Other Topical Corticosteroids in the Treatment of Moderate to Severe Scalp Psoriasis

Important dates

Study start
2007
Primary completion
2008
Study completion
2008
First posted
Feb 22, 2007
Registry last updated
Feb 18, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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