Expired Study
This study is not currently recruiting Study Participants on ClinicalConnection.com. If you would like to find active studies please search for clinical trials.

Boca Raton, Florida 33428


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.


Study summary:

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.


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.


Study is Available At:


Original ID:

U0275-01


NCT ID:

NCT00703846


Secondary ID:

U0275-01


Study Acronym:


Brief Title:

Long Term Study of Extina in Patients With Seborrheic Dermatitis


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.


Overall Status:

Completed


Study Phase:

Phase 4


Genders:

Both


Minimum Age:

12 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

GlaxoSmithKline


Oversight Authority:

  • United States: Institutional Review Board
  • United States: Food and Drug Administartion


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Endpoint Classification: Safety Study, Interventi


Number of Arms:

1


Number of Groups:

0


Total Enrollment:

500


Enrollment Type:

Actual


Overall Contact Information

Official Name:GSK Clinical Trials
Study Director
GlaxoSmithKline

Study Dates

Start Date:June 2008
Completion Date:June 2010
Completion Type:Actual
Primary Completion Date:April 2010
Primary Completion Type:Actual
Verification Date:June 2011
Last Changed Date:June 30, 2011
First Received Date:June 20, 2008

Study Outcomes

Outcome Type:Primary Outcome
Measure:To assess the long-term safety of Extina (ketoconazole) Foam, 2% in the treatment of seborrheic dermatitis.
Time Frame:1 year
Safety Issues:False

Study Interventions

Intervention Type:Drug
Name:Extina (ketoconazole) foam, 2%
Description: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.
Arm Name:Open Label

Study Arms

Study Arm Type:Experimental
Arm Name:Open Label
Description:Open Label

Study Agencies

Agency Class:Industry
Agency Type:Lead Sponsor
Agency Name:Stiefel, a GSK Company

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

Modifications to this listing: Only selected fields are shown, please use the link below to view all information about this clinical trial.


This study is not currently recruiting Study Participants. The form below is not enabled.