Subject Preference for Scalp Psoriasis Treatment - Full Text View

Sponsor:	Galderma
Information provided by:	Galderma
ClinicalTrials.gov Identifier:	NCT00438399

Purpose

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.

Condition	Intervention	Phase
Scalp Psoriasis	Drug: Active product - Comparator 1 Drug: Active product - Comparator 2 Drug: Active product - Comparator 3	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind (Investigator), Active Control, Crossover Assignment, Efficacy Study
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

Resource links provided by NLM:

MedlinePlus related topics: Psoriasis

Drug Information available for: Clobetasol Clobetasol propionate

U.S. FDA Resources

Further study details as provided by Galderma:

Primary Outcome Measures:

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

Secondary Outcome Measures:

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

Enrollment:	240
Study Start Date:	February 2007
Study Completion Date:	February 2008
Primary Completion Date:	January 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator Clobetasol propionate Shampoo compared to comparator 1	Drug: Active product - Comparator 1 Twice daily application
2: Active Comparator Clobetasol propionate Shampoo compared to comparator 2	Drug: Active product - Comparator 2 Twice daily application
3: Active Comparator Clobetasol propionate Shampoo compared to comparator 3	Drug: Active product - Comparator 3 twice daily

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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).

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00438399

Locations

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

Sponsors and Collaborators

Galderma

Investigators

Principal Investigator:

Alberto Giannetti, Professor

Clinica Dermatologica Azienda Ospedaliera Policinico di Modena - Italy

More Information

Additional Information:

Related Info This link exits the ClinicalTrials.gov site

No publications provided

Study ID Numbers:	RD.03.SPR.29064, Eudract n°2006-003073-27
Study First Received:	February 21, 2007
Last Updated:	August 4, 2008
ClinicalTrials.gov Identifier:	NCT00438399 History of Changes
Health Authority:	Italy: Ministry of Health; Germany: Federal Institute for Drugs and Medical Devices; United Kingdom: Medicines and Healthcare Products Regulatory Agency; Spain: Spanish Agency of Medicines

Keywords provided by Galderma:

1 Galderma,
2 Scalp Psoriasis
3 Subject preference
4 Clobetasol propionate
5 Shampoo

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Clobetasol
Skin Diseases
Psoriasis
Therapeutic Uses
Physiological Effects of Drugs

Hormones, Hormone Substitutes, and Hormone Antagonists
Hormones
Glucocorticoids
Skin Diseases, Papulosquamous
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 08, 2010