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Long Term Study of Extina in Patients With Seborrheic Dermatitis
This study has been completed.

First Received on June 20, 2008.   Last Updated on June 30, 2011   History of Changes
Sponsor: Stiefel, a GSK Company
Information provided by: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00703846
  Purpose

Open-label, multicenter, single-group study to assess the long-term safety of twice daily treatment with Extina (ketoconazole) Foam, 2% in subjects with seborrheic dermatitis.


Condition Intervention Phase
Seborrheic Dermatitis
Drug: Extina (ketoconazole) foam, 2%
Phase IV

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase 4, Open-label Study to Assess the Long-term Safety of Extina (Ketoconazole) Foam, 2% in the Treatment of Seborrheic Dermatitis.

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • To assess the long-term safety of Extina (ketoconazole) Foam, 2% in the treatment of seborrheic dermatitis. [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Enrollment: 500
Study Start Date: June 2008
Study Completion Date: June 2010
Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Open Label
Open Label
Drug: Extina (ketoconazole) foam, 2%
All subjects will apply Extina (ketoconazole) Foam, 2% topically twice a day (morning and evening) to all seborrheic dermatitis lesions on the face, scalp, ears, neck, and chest. Study product should be applied at the first sign of a seborrheic dermatitis flare, and twice daily applications should continue until the area(s) has cleared.

Detailed Description:

The study subjects must have seborrheic dermatitis and will apply Extina (ketoconazole) Foam, 2% topically twice a day (morning and evening) to all seborrheic dermatitis lesions on the face, scalp, ears, neck, and chest until resolution throughout the 12 month study period.

Study visits will occur at baseline (day 1) and at weeks 4, 8, 16, 26, 39, and 52 (or early withdrawal). Safety will be assessed by evaluation of adverse events (AEs), vital signs, physical examinations, withdrawals from the study, and results of safety laboratory tests.

  Eligibility

Ages Eligible for Study:   12 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Capable of understanding and willing to provide signed and dated written voluntary informed consent before any protocol specific procedures are performed. For subjects between the ages of 12 and 17 years, a parent or legal guardian must be capable of understanding and willing to sign informed consent and subject must be capable of understanding and willing to sign an adolescent assent.
  • Male or female subjects 12 years of age or older.
  • Able to complete the study and to comply with study instructions.
  • Female subjects of childbearing potential must have a negative pregnancy test. Sexually active women of childbearing potential participating in the study must agree to use a medically acceptable form of contraception .
  • Seborrheic dermatitis on the face, scalp, ears, neck, or chest

Exclusion Criteria:

  • Use of systemic antifungal agents, corticosteroids or other immunosuppressive therapies, or systemic retinoids within 4 weeks prior to the baseline visit.
  • Use of topical antifungal therapy, corticosteroid therapy, or calcineurin inhibitors to the face, scalp, ears, neck, or chest within 2 weeks prior to the baseline visit.
  • Use of any investigational drugs within 4 weeks prior to the baseline visit, or subjects scheduled to receive an investigative drug other than the study product during the period of the study.
  • History of known or suspected intolerance to any of the ingredients of the study product.
  • Female subjects who are pregnant, trying to become pregnant or lactating.
  • Any clinically relevant abnormal vital signs or findings on the physical examination or clinically significant condition which would, in the opinion of the investigator, compromise the subject's participation in the study.
  • Considered unable or unlikely to attend the necessary visits.
  • Currently using any medication, which in the opinion of the investigator may affect the evaluation of the study product or place the subjects at undue risk.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00703846

Locations
United States, Alabama
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35233
United States, Delaware
Guy Webster
Hockessin, Delaware, United States, 19707
United States, Florida
The Dermatology and Aesthetic Center
Boca Raton, Florida, United States, 33486
The Weiss Skin Institute
Boca Raton, Florida, United States, 33428
Dermatology Associates & Research
Coral Gables, Florida, United States, 33134
Spencer Dermatology & Skin Surgery
St. Petersburg, Florida, United States, 33716
United States, Louisiana
Tulane University
New Orleans, Louisiana, United States, 70112
United States, Massachusetts
Massachusettes General Hospital
Boston, Massachusetts, United States, 02114
United States, Michigan
Henry Ford Medical Center
Detroit, Michigan, United States, 48202
United States, North Carolina
Dermatology Consulting Services
High Point, North Carolina, United States, 27262
Wake Forest University Health Sciences
Winston Salem, North Carolina, United States, 27157
United States, Oregon
Oregon Dermatology and Research Center
Portland, Oregon, United States, 97210
United States, Rhode Island
Clinical Partners, LLC
Johnston, Rhode Island, United States, 02919
United States, Texas
Arlington Center for Dermatology
Arlington, Texas, United States, 76011
DermReserach, Inc.
Austin, Texas, United States, 78759
University of Texas Southwestern Medical Center
Dallas, Texas, United States, 75930
Dermatology Treatment & Research Center
Dallas, Texas, United States, 75230
Baylor Research Institute
Dallas, Texas, United States, 75246
United States, Virginia
Virginia Clinical Research, Inc.
Norfolk, Virginia, United States, 23507
Sponsors and Collaborators
Stiefel, a GSK Company
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: Cheri A. Hudson; Clinical Disclosure Advisor, GSK Clinical Disclosure
ClinicalTrials.gov Identifier: NCT00703846     History of Changes
Obsolete Identifiers: NCT01337284
Other Study ID Numbers: U0275-01, U0275-01
Study First Received: June 20, 2008
Last Updated: June 30, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:
Dermatitis
Seborrheic Dermatitis

Additional relevant MeSH terms:
Dermatitis
Dermatitis, Seborrheic
Skin Diseases
Sebaceous Gland Diseases
Skin Diseases, Eczematous
Skin Diseases, Papulosquamous
Ketoconazole
14-alpha Demethylase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antifungal Agents
Anti-Infective Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on February 12, 2012