Pityrosporum Folliculitis Clinical Trial
Official title:
An Open-Label, Proof of Concept Study to Determine the Safety and Efficacy of Ketoconazole 2% Foam in the Treatment of Pityrosporum Folliculitis
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.
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.
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