Clobetasol Propionate 0.05% Shampoo in Association With Antifungal Shampoo in Scalp Seborrheic Dermatitis
Information source: Galderma
Information obtained from ClinicalTrials.gov on October 19, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Scalp Seborrheic Dermatitis
Intervention: clobetasol propionate shampoo - ketoconazole shampoo (Drug)
Phase: Phase 3
Status: Recruiting
Sponsored by: Galderma Official(s) and/or principal investigator(s):
Jean-Paul Ortonne, MD, Principal Investigator, Affiliation: Nice Hospital (France)
Overall contact:
Fabrice Pollier, Phone: 33-4-93-95-70-33, Email: fabrice.pollier@galderma.com
Summary
The objective is to assess different treatment regimens with Clobetasol propionate shampoo
0. 05% in association with an antifungal shampoo (Ketoconazole 2%) in the treatment of
moderate to severe scalp Seborrheic Dermatitis compared to the antifungal shampoo alone.
Clinical Details
Official title: Efficacy and Safety of Clobetasol Propionate Shampoo 0.05% Used in Association With an Antifungal Shampoo in the Treatment of Moderate to Severe Scalp Seborrheic Dermatitis
Study design: Treatment, Randomized, Single Blind (Investigator), Active Control, Parallel Assignment, Efficacy Study
Primary outcome: Percent change from Baseline in Total Severity Score
Secondary outcome: Scalp Seborrheic Dermatitis Individual sign score - Extent index - SDASI - AE
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Subjects with moderate to severe scalp Seborrheic Dermatitis
Exclusion Criteria:
- Subjects suffering from psoriasis,
- Subjects with a known allergy to one of the components of the test products,
- Female subjects who are pregnant, nursing or planning a pregnancy during the study
Locations and Contacts
Fabrice Pollier, Phone: 33-4-93-95-70-33, Email: fabrice.pollier@galderma.com
Galderma Investigational Center, Liege, Belgium; Recruiting
Galderma Investigational Center, Mons, Belgium; Recruiting
Galderma Investigational Center, Gent, Belgium; Recruiting
Galderma Investigational Center, Brugge, Belgium; Not yet recruiting
Galderma Investigational Center, Bruxelles, Belgium; Not yet recruiting
Galderma Investigational Center, Geel, Belgium; Not yet recruiting
Galderma Investigational Center, Paris, France; Recruiting
Galderma Investigational Center, Bonn, Germany; Recruiting
Galderma Investigational Center, Wuppertal, Germany; Recruiting
Galderma Investigational Center, Lubeck, Germany; Recruiting
Galderma Investigational Center, Berlin, Germany; Recruiting
Galderma Investigational Center, Hamburg, Germany; Recruiting
Galderma Investigational Center, Mahlow, Germany; Recruiting
Galderma Investigational Center, Seoul, Korea, Republic of; Recruiting
Galderma Investigational Center, Mexico, Mexico; Not yet recruiting
Galderma Investigational Center, Zapopan, Jalisco, Mexico; Not yet recruiting
Galderma Investigational Center, Naucalpan, Mexico; Not yet recruiting
Galderma Investigational Center, Guadalajara, Mexico; Not yet recruiting
Additional Information
Starting date: March 2009
Ending date: January 2010
Last updated: September 18, 2009
|
