CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 498 enrolled
Drug / intervention
Ketoconazoledrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00703846
NCT00703846Phase 4Completed
CompareCT.gov

A PHASE 4, OPEN-LABEL STUDY TO ASSESS THE LONG-TERM SAFETY OF EXTINA (KETOCONAZOLE) FOAM, 2% IN THE TREATMENT OF SEBORRHEIC DERMATITIS

Stiefel, a GSK Company·interventional·Posted Jun 24, 2008·Updated Jan 30, 2017

In Brief

A Phase 4 clinical trial evaluating Ketoconazole for Dermatitis, Seborrheic. Completed, enrolled 498 participants.

Detailed Summary

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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDermatitis, Seborrheic
Countries--
CollaboratorsGlaxoSmithKline

Timeline

Phase 4CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJun 24, 2008
Enrollment StartJun 1, 2008
Primary CompletionApr 1, 2010
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 18.0 years ago

Interventions

Ketoconazoledrug

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.