Safety and Efficacy of Ketoconazole 2% Foam in the Treatment of Pityrosporum Folliculitis
Condition: Pityrosporum Folliculitis
MeSH terms: Folliculitis
Study type: Interventional
Phase: Phase 4

Summary: 
      Pityrosporum folliculitis presents as fine superficial follicular pustules and papules on the
      trunk and upper extremities. Ketoconazole 2% foam was recently approved for the treatment of
      seborrheic dermatitis in immunocompetent patients 12 years and older. Ketoconazole 2% foam is
      felt to work by reducing the number of pityrosporum yeast organisms. Safety and efficacy of
      ketoconazole 2% foam treatment for this fungal infections has not been established. This
      study is to demonstrate efficacy and safety in the treatment of pityrosporum folliculitis.
    

Detailed description: 
      Malassezia/pityrosporum species is a ubiquitous saprophyte of human skin. This organism is
      implicated in the etiology of seborrheic dermatitis, tinea versicolor, and pityrosporum
      folliculitis. The prevalence of pityrosporum folliculitis is especially high in warm and
      humid environments, although its presence is universal. Pityrosporum folliculitis presents in
      immuno-competent, acne-prone young adults as fine superficial follicular pustules and papules
      on the trunk and upper extremities. There are no comedones. This acneiform condition is
      non-scarring. It causes significant morbidity for patients as it is frequently mistaken for
      acne vulgaris with scarring potential, often associated with pruritis, and fails to respond
      to adequate conventional acne treatment- systemic antibiotics, topical benzoyl peroxide, and
      topical retinoids. Pityrosporum folliculitis can be the sole presenting condition or it can
      coexist with acne vulgaris. Less commonly, patients with pityrosporum folliculitis present
      with associated tinea versicolor and seborrheic dermatitis. The diagnosis is made by clinical
      presentation, microscopic examination for the pustule for spores/hyphae, skin biopsy, and
      retrospectively following good response to antimycotic therapy.

      Ketoconazole 2% foam was recently approved for the treatment of seborrheic dermatitis in
      immunocompetent patients 12 years and older. Safety and efficacy of ketoconazole 2% foam
      treatment for pityrosporum folliculitis has not been established. Prior to the availability
      of the ketoconazole 2% foam, successful treatment of pityrosporum folliculitis required
      systemic anti fungal drugs such as ketoconazole, itraconazole and fluconazole. It also
      responds to oral isotretinoin. Systemic antimycotics are effective but repeated use of these
      drugs incurs safety concerns including hepatotoxicity and drug-drug interactions. Oral
      isotretinoin is indicated for severe nodulo-cystic acne and generally is inappropriate as a
      routine treatment modality for pityrosporum folliculitis. As pityrosporum folliculitis is a
      non-scarring acneiform condition and can be recurrent, effective and safe, patient initiated
      topical treatment would be a more appropriate form of therapy.The objective of this study is
      to demonstrate that ketoconazole 2% foam may be the treatment of choice for pityrosporum
      folliculitis.
    

Intervention name(s): ketoconazole 2% foam
Intervention type(s): Drug
Intervention description(s): topical antifungal foam to be applied to the folliculitis BID for 2-4 weeks.
Other intervention name(s): ketaconozole 2% foam brand name is Extina Foam.
Intervention MeSH terms: Ketoconazole
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: pityrosporum folliculitis; ketoconazole 2% foam