Sponsor study identifier
interventional
498
0 countries
N/A
Study Start
June 2008
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
April 2010
Actual (reported)Study Completion
April 2010
Actual (reported)Extina (ketoconazole) Foam, 2% was approved for marketing in the United States (US) in June 2007. Extina foam is indicated for topical treatment of seborrheic dermatitis in immunocompetent patients 12 years of age and older. The approved dosing regimen is twice daily for 4 weeks. The treatment of recurrent seborrheic dermatitis demands a topical preparation that is safe for both short-term and chronic application. This study is being conducted in order to obtain long-term safety data on the use of Extina (ketoconazole) Foam, 2% in the treatment of seborrheic dermatitis.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
April 2010
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
June 2008
Date type not reportedThis date has not been verified as actual or estimated.
June 20, 2008
Actual (reported)June 24, 2008
Actual (reported)April 2010
Actual (reported)April 2010
Actual (reported)February 23, 2012
Actual (reported)Number of Participants With Any Adverse Event (AE)
An AE is any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, which does not necessarily have a causal relationship with the treatment. For a list of all adverse events occurring at or above a frequency threshold of 5% during the course of the study, see the table entitled "Other (Non-Serious) Adverse Events."
From baseline through 52 weeks
Mean Change From Baseline in Skin Assessments for Erythema at Weeks 4, 8, 16, 26, 39, and 52 (or Early Termination)
Baseline and Weeks 4, 8, 16, 26, 39, and 52 (or early termination)
Mean Change From Baseline in Skin Assessments for Scaling at Weeks 4, 8, 16, 26, 39, and 52 (or Early Termination)
Baseline and Weeks 4, 8, 16, 26, 39, and 52 (or early termination)
Mean Change From Baseline in Skin Assessments for Pruritus at Weeks 4, 8, 16, 26, 39, and 52 (or Early Termination)
Baseline and Weeks 4, 8, 16, 26, 39, and 52 (or early termination)
Mean Change From Baseline in Investigator's Static Global Assessment (ISGA) at Weeks 4, 8, 16, 26, 39, and 52 (or Early Termination)
Baseline and Weeks 4, 8, 16, 26, 39, and 52 (or early termination)
Median Number of Flares
From baseline through 52 weeks
Foam, 2%, Extina will be applied twice daily (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. All symptom flares should be treated throughout the 12-month study period.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Draelos ZD, Feldman SR, Butners V, Alio Saenz AB. Long-term safety of ketoconazole foam, 2% in the treatment of seborrheic dermatitis: results of a phase IV, open-label study. J Drugs Dermatol. 2013 Jan;12(1):e1-6.
GSK Clinical Trials
GlaxoSmithKline
498 participants (actual enrollment reported by the registry).
First Submitted
June 20, 2008
First Posted
June 24, 2008
Study Start
June 2008
Date type not reportedThis date has not been verified as actual or estimated.
Efficacy and Safety of ASF1057 in the Treatment of Seborrhoeic Dermatitis
Contact the study team to confirm eligibility.
Primary Completion
April 2010
Actual (reported)Study Completion
April 2010
Actual (reported)Last Updated
January 30, 2017
Results First Posted
February 23, 2012
Record last verified: 2016-12
Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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