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

Sponsor:	Galderma
Information provided by (Responsible Party):	Galderma
ClinicalTrials.gov Identifier:	NCT00862654

Purpose

The objective is to assess different treatment regimens with Clobetasol propionate shampoo 0.05% in the treatment of scalp Seborrheic Dermatitis.

Condition	Intervention	Phase
Scalp Seborrheic Dermatitis	Drug: 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)	Phase III

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

Total Severity Score (TSS): Percent Change From Baseline at Week 4 [ Time Frame: baseline and week 4 ] [ Designated as safety issue: No ]
Total Severity Score (TSS) is sum of erythema, scaling and pruritus severity scores of the lesions evaluated each on a 4-point scale from 0 = None to 3 = Severe by the investigator. So minimum TSS can be 0 and maximum 9.

Enrollment:	326
Study Start Date:	March 2009
Study Completion Date:	February 2010
Primary Completion Date:	February 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: C propionate 4/week + Ketoconasole 2/week Clobetasol propionate shampoo 0.05% (4/week) + Ketoconazole shampoo 2% (2/week)	Drug: clobetasol propionate shampoo (4/week) - ketoconazole shampoo (2/week) Association: clobetasol propionate shampoo & ketoconazole shampoo
Experimental: C propionate 2/week + Ketoconasole 2/week Clobetasol propionate shampoo 0.05% (2/week) + Ketoconazole shampoo 2% (2/week)	Drug: clobetasol propionate shampoo (2/week) - ketoconazole shampoo (2/week) Association: clobetasol propionate shampoo & ketoconazole shampoo
Experimental: C propionate 2/week Clobetasol propionate shampoo 0.05% (2/week)	Drug: clobetasol propionate shampoo (2/week) Monotherapy with clobetasol propionate shampoo
Active Comparator: Ketoconazole 2/week Ketoconazole shampoo 2% (2/week)	Drug: ketoconazole shampoo (2/week) Monotherpay ketoconazole shampoo (2/week)

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

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
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
France
Galderma Investigational Center
Paris, France
Germany
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
Korea, Republic of
Galderma Investigational Center
Seoul, Korea, Republic of
Mexico
Galderma Investigational Center
Guadalajara, Mexico
Galderma Investigational Center
Mexico, Mexico
Galderma Investigational Center
Naucalpan, Mexico
Galderma Investigational Center
Zapopan, Jalisco, Mexico

Sponsors and Collaborators

Galderma

Investigators

Principal Investigator:

Jean-Paul Ortonne, MD

Nice Hospital (France)

More Information

Additional Information:

Sponsor general information This link exits the ClinicalTrials.gov site

No publications provided by Galderma

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Ortonne JP, Nikkels AF, Reich K, Ponce Olivera RM, Lee JH, Kerrouche N, Sidou F, Faergemann J. Efficacious and safe management of moderate to severe scalp seborrhoeic dermatitis using clobetasol propionate shampoo 0·05% combined with ketoconazole shampoo 2%: a randomized, controlled study. Br J Dermatol. 2011 Jul;165(1):171-6.

Responsible Party:	Galderma
ClinicalTrials.gov Identifier:	NCT00862654 History of Changes
Other Study ID Numbers:	RD.03.SPR.29079
Study First Received:	March 15, 2009
Results First Received:	June 15, 2011
Last Updated:	August 31, 2011
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:

Dermatitis
Dermatitis, Seborrheic
Skin Diseases
Sebaceous Gland Diseases
Skin Diseases, Eczematous
Skin Diseases, Papulosquamous
Antifungal Agents
Ketoconazole
Clobetasol
Anti-Infective Agents

Therapeutic Uses
Pharmacologic Actions
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
14-alpha Demethylase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on February 09, 2012