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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00862654
First Posted: March 17, 2009
Last Update Posted: September 1, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Galderma
  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 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (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:


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 ]
    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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Galderma
ClinicalTrials.gov Identifier: NCT00862654     History of Changes
Other Study ID Numbers: RD.03.SPR.29079
First Submitted: March 15, 2009
First Posted: March 17, 2009
Results First Submitted: June 15, 2011
Results First Posted: August 12, 2011
Last Update Posted: September 1, 2011
Last Verified: August 2011

Additional relevant MeSH terms:
Dermatitis
Dermatitis, Seborrheic
Skin Diseases
Sebaceous Gland Diseases
Skin Diseases, Eczematous
Skin Diseases, Papulosquamous
Ketoconazole
Antifungal Agents
Miconazole
Clobetasol
Anti-Infective Agents
14-alpha Demethylase Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Steroid Synthesis Inhibitors
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Cytochrome P-450 CYP3A Inhibitors
Cytochrome P-450 CYP2C9 Inhibitors
Anti-Inflammatory Agents
Glucocorticoids
Hormones