Subject Preference for Scalp Psoriasis Treatment

Scalp Psoriasis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00438399
• Other study ID #: RD.03.SPR.29064
• Secondary ID: 2006-003073-27
• Status: Completed
• Phase: Phase 3
• Start date: February 2007
• Est. completion date: February 2008

Study information

• Verified date: November 2011
• Source: Galderma R&D
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 219
• Est. completion date: February 2008
• Est. primary completion date: January 2008
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Psoriasis
• Scalp Psoriasis

Intervention

Drug:
• C. propionate - Corticosteroid 1
Twice daily application
• C. propionate- Corticosteroid 2
Twice daily application
• C. propionate -Corticosteroid 3
Twice daily application
• Corticosteroid 1- C. propionate
Twice daily application
• Corticosteroid 2 - C. propionate
Twice daily application
• Corticosteroid 3 - C. propionate
Twice daily application

Locations

Country	Name	City	State
Italy	Clinica Dermatologica Azienda Ospedaliera Policlinico di Modena	Modena

Sponsors (1)

Lead Sponsor	Collaborator
Galderma R&D

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)

External Links

•   Study product information