Clobetasol Propionate 0.05% Shampoo in Association With Antifungal Shampoo in Scalp Seborrheic Dermatitis - Full Text View

Sponsor:	Galderma
Information provided by:	Galderma
ClinicalTrials.gov Identifier:	NCT00862654

Purpose

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.

Condition	Intervention	Phase
Scalp Seborrheic Dermatitis	Drug: clobetasol propionate shampoo - ketoconazole shampoo	Phase III

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

Resource links provided by NLM:

Drug Information available for: Clobetasol Clobetasol propionate Ketoconazole Fungarest

U.S. FDA Resources

Further study details as provided by Galderma:

Primary Outcome Measures:

Percent change from Baseline in Total Severity Score [ Time Frame: Week 4 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Scalp Seborrheic Dermatitis Individual sign score - Extent index - SDASI - AE [ Time Frame: Each study visit ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	320
Study Start Date:	March 2009
Estimated Study Completion Date:	January 2010
Estimated Primary Completion Date:	December 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Clobetasol propionate shampoo 0.05% (4/week) + Ketoconazole shampoo 2% (2/week)	Drug: clobetasol propionate shampoo - ketoconazole shampoo association between clobetasol propionate shampoo and ketoconazole shampoo
2: Experimental Clobetasol propionate shampoo 0.05% (2/week) + Ketoconazole shampoo 2% (2/week)	Drug: clobetasol propionate shampoo - ketoconazole shampoo association between clobetasol propionate shampoo and ketoconazole shampoo
3: Experimental Clobetasol propionate shampoo 0.05% (2/week)	Drug: clobetasol propionate shampoo - ketoconazole shampoo association between clobetasol propionate shampoo and ketoconazole shampoo
4: Active Comparator Ketoconazole shampoo 2% (2/week)	Drug: clobetasol propionate shampoo - ketoconazole shampoo association between clobetasol propionate shampoo and ketoconazole shampoo

Eligibility

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

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00862654

Locations

Belgium
Galderma Investigational Center
Liege, Belgium
Galderma Investigational Center
Mons, Belgium
Galderma Investigational Center
Gent, Belgium
Galderma Investigational Center
Brugge, Belgium
Galderma Investigational Center
Bruxelles, Belgium
Galderma Investigational Center
Geel, Belgium
France
Galderma Investigational Center
Paris, France
Germany
Galderma Investigational Center
Bonn, Germany
Galderma Investigational Center
Wuppertal, Germany
Galderma Investigational Center
Lubeck, Germany
Galderma Investigational Center
Berlin, Germany
Galderma Investigational Center
Hamburg, Germany
Galderma Investigational Center
Mahlow, Germany
Korea, Republic of
Galderma Investigational Center
Seoul, Korea, Republic of
Mexico
Galderma Investigational Center
Guadalajara, Mexico
Galderma Investigational Center
Zapopan, Jalisco, Mexico
Galderma Investigational Center
Naucalpan, Mexico
Galderma Investigational Center
Mexico, Mexico

Sponsors and Collaborators

Galderma

Investigators

Principal Investigator:

Jean-Paul Ortonne, MD

Nice Hospital (France)

More Information

Additional Information:

Related Info This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Galderma ( Fabrice POLLIER Clinical Project Manager )
Study ID Numbers:	RD.03.SPR.29079
Study First Received:	March 15, 2009
Last Updated:	November 27, 2009
ClinicalTrials.gov Identifier:	NCT00862654 History of Changes
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices; France: Afssaps - French Health Products Safety Agency; Belgium: Federal Agency for Medicinal Products and Health Products; Mexico: Ministry of Health; South Korea: Korea Food and Drug Administration (KFDA)

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Anti-Infective Agents
Skin Diseases
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Sebaceous Gland Diseases
Ketoconazole
Hormones
Glucocorticoids

Pharmacologic Actions
Dermatitis, Seborrheic
Clobetasol
Antifungal Agents
Therapeutic Uses
Skin Diseases, Eczematous
Skin Diseases, Papulosquamous
Dermatitis

ClinicalTrials.gov processed this record on February 08, 2010