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Clobetasol Propionate 0.05% Shampoo in Association With Antifungal Shampoo in Scalp Seborrheic Dermatitis

Information source: Galderma
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Scalp Seborrheic Dermatitis

Intervention: clobetasol propionate shampoo (4/week) - ketoconazole shampoo (2/week) (Drug); clobetasol propionate shampoo (2/week) - ketoconazole shampoo (2/week) (Drug); clobetasol propionate shampoo (2/week) (Drug); ketoconazole shampoo (2/week) (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Galderma

Official(s) and/or principal investigator(s):
Jean-Paul Ortonne, MD, Principal Investigator, Affiliation: Nice Hospital (France)

Summary

The objective is to assess different treatment regimens with Clobetasol propionate shampoo 0. 05% in the treatment of scalp Seborrheic Dermatitis.

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: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Primary outcome: Total Severity Score (TSS): Percent Change From Baseline at Week 4

Detailed description: 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.

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

Galderma Investigational Center, Brugge, Belgium

Galderma Investigational Center, Bruxelles, Belgium

Galderma Investigational Center, Geel, Belgium

Galderma Investigational Center, Gent, Belgium

Galderma Investigational Center, Liege, Belgium

Galderma Investigational Center, Mons, Belgium

Galderma Investigational Center, Paris, France

Galderma Investigational Center, Berlin, Germany

Galderma Investigational Center, Bonn, Germany

Galderma Investigational Center, Hamburg, Germany

Galderma Investigational Center, Lubeck, Germany

Galderma Investigational Center, Mahlow, Germany

Galderma Investigational Center, Wuppertal, Germany

Galderma Investigational Center, Seoul, Korea, Republic of

Galderma Investigational Center, Guadalajara, Mexico

Galderma Investigational Center, Mexico, Mexico

Galderma Investigational Center, Naucalpan, Mexico

Galderma Investigational Center, Zapopan, Jalisco, Mexico

Additional Information

Sponsor general information

Starting date: March 2009
Last updated: August 31, 2011

Page last updated: August 23, 2015

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