Extina (ketoconazole)

Company
Stiefel

Approval Status
Approved June 2007

Treatment for
seborrheic dermatitis

Areas
Dermatology / Plastic Surgery , Immune System

Extina foam contains 2% ketoconazole USP, an antifungal agent. The mechanism of action of ketoconazole in the treatment of seborrheic dermatitis is not known.

Extina is specifically indicated for the treatment of seborrheic dermatitis in immunocompetent patients 12 years of age and older.

Extina is supplied as a foam designed for topical administration. The recommended initial dose of the drug is application to the affected area(s) twice daily for four weeks.

FDA Approval
FDA approval of Extina was based on the results of a randomized, double-blind, vehicle-controlled study. This trial enrolled 847 subjects 12 years and older with mild to severe seborrheic dermatitis. Subjects received Extina foam or vehicle foam applied twice daily for 4 weeks to affected areas on the face, scalp, and/or chest. Overall disease severity, including erythema, scaling, and induration were assessed at baseline and week 4 on a 5-point Investigator’s Static Global Assessment (ISGA) scale. Treatment success was defined as achieving a Week 4 ISGA score of 0 (clear) or 1 (mild or faint) and at least two grades of improvement from baseline. Treatment success was reached in 56% of the subjects receiving Extina compared to 42% on vehicle foam.

Adverse events associated with the use of Extina may include, but are not limited to, the following:

  • Application site burning
  • Application site reactions including:
  • Dryness
  • Erythema
  • Irritation
  • Paresthesia
  • Pruritus
  • Rash
  • Warmth

Extina foam contains 2% ketoconazole USP, an antifungal agent. The mechanism of action of ketoconazole in the treatment of seborrheic dermatitis is not known. Ketoconazole inhibits the in vitro synthesis of ergosterol, a key sterol in the cell membrane of Malassezia furfur.

For additional information regarding Extina or seborrheic dermatitis, please visit the Extina web page.

Extina Drug Information

The Extina drug information shown above is licensed from Thomson CenterWatch. The information provided here is for general educational purposes only and does not constitute medical or pharmaceutical advice which should be sought from qualified medical and pharmaceutical advisers.

Scroll to top