STUDY TO ASSESS THE LONG-TERM SAFETY OF EXTINA (KETOCONAZOLE) FOAM, 2%

Dermatitis, Seborrheic Clinical Trial

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

Status Completed

Clinical Trial 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.

Clinical Trial Description

This is an 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.

The study subjects must have seborrheic dermatitis with an Investigator's Static Global Assessment (ISGA) of 2, 3, or 4 at baseline. In addition, subjects must have a discrete, evaluable target area of at least 0.5 cm2, with a score of 2, 3, or 4 for erythema and scaling.

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. All symptom flares should be treated 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). See the study flowchart (section 3) for the assessments to be performed at each visit. Primary Objective: To assess the long-term safety of Extina (ketoconazole) Foam, 2% in the treatment of seborrheic dermatitis. ;

Study Design

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Dermatitis
• Dermatitis, Seborrheic
• Eczema

• NCT number: NCT00703846
• Study type: Interventional
• Source: GlaxoSmithKline
• Status: Completed
• Phase: Phase 4
• Start date: June 2008
• Completion date: June 2010