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Home » Drug Information » FDA Approved Drugs » 2007
Medical Areas: Dermatology | Immunology

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Extina (ketoconazole)

The following drug information is obtained from various newswires, published medical journal articles, and medical conference presentations.

Company: Stiefel
Approval Status: Approved June 2007
Treatment Area: seborrheic dermatitis

General Information

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.

Clinical Results

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.

Side Effects

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

Mechanism of Action

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.

Literature References

Faergemann J, Borgers M, Degreef H A new ketoconazole topical gel formulation in seborrhoeic dermatitis: an updated review of the mechanism. Expert opinion on pharmacotherapy 2007 Jun;8(9):1365-71

Elewski B, Ling MR, Phillips TJ Efficacy and safety of a new once-daily topical ketoconazole 2% gel in the treatment of seborrheic dermatitis: a phase III trial. Journal of drugs in dermatology : JDD 2006 Jul-Aug;5(7):646-50

Huang X, Tanojo H, Lenn J, Deng CH, Krochmal L A novel foam vehicle for delivery of topical corticosteroids. Journal of the American Academy of Dermatology 2005 Jul;53(1 Suppl 1):S26-38

Piérard-Franchimont C, Piérard GE A double-blind placebo-controlled study of ketoconazole + desonide gel combination in the treatment of facial seborrheic dermatitis. Dermatology 2002;204(4):344-7

Additional Information

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