Subject Preference for Scalp Psoriasis Treatment - Tabular View

Tracking Information

First Received Date ^ICMJE

February 21, 2007

Last Updated Date

August 4, 2008

Start Date ^ICMJE

February 2007

Primary Completion Date

January 2008 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Subjects' Overall preference [ Time Frame: study end ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Subjects’ Overall preference

Change History

Complete list of historical versions of study NCT00438399 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Global Severity score (GSS),Total severity score (TSS) [ Time Frame: at the end of each treatment period ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Global Severity score (GSS),Total severity score (TSS)

Descriptive Information

Brief Title ^ICMJE

Subject Preference for Scalp Psoriasis Treatment

Official Title ^ICMJE

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

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.

Study Phase

Phase III

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Allocation:  Randomized
Control:  Active Control
Endpoint Classification:  Efficacy Study
Intervention Model:  Crossover Assignment
Masking:  Single Blind (Investigator)
Primary Purpose:  Treatment

Condition ^ICMJE

Scalp Psoriasis

Intervention ^ICMJE

Drug: Active product - Comparator 1
Twice daily application
Drug: Active product - Comparator 2
Twice daily application
Drug: Active product - Comparator 3
twice daily

Study Arms / Comparison Groups

1: Active Comparator
Clobetasol propionate Shampoo compared to comparator 1

Intervention: Drug: Active product - Comparator 1
2: Active Comparator
Clobetasol propionate Shampoo compared to comparator 2

Intervention: Drug: Active product - Comparator 2
3: Active Comparator
Clobetasol propionate Shampoo compared to comparator 3

Intervention: Drug: Active product - Comparator 3

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

240

Completion Date

February 2008

Primary Completion Date

January 2008 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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).

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Italy

Administrative Information

NCT ID ^ICMJE

NCT00438399

Responsible Party

Study ID Numbers ^ICMJE

RD.03.SPR.29064, Eudract n°2006-003073-27

Study Sponsor ^ICMJE

Galderma

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator:

Alberto Giannetti, Professor

Clinica Dermatologica Azienda Ospedaliera Policinico di Modena - Italy

Information Provided By

Galderma

Verification Date

August 2008

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP