CompletedPhase 4

Safety and Efficacy of Ketoconazole 2% Foam in the Treatment of Pityrosporum Folliculitis

United States10 participantsStarted 2008-12

Plain-language 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.

Who can participate

Age range18 Years – 65 Years

SexALL

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Inclusion criteria

✓. Diagnosis of pityrosporum folliculitis will be established by clinical presentation - fine, superficial follicular papules and pustules on the chest, back, and upper arms. KOH will be done on the pustules looking for spores and hyphae.
✓. Concomitant acne treatments with standard acne treatment modalities will be allowed - oral and topical antibiotics, topical retinoids, and benzoyl peroxides.

Exclusion criteria

✕. Pregnancy and breast feeding
✕. Patients with nodulocystic acne on the trunk
✕. Current or prior treatment with oral isotretinoin
✕. Patients allergic to the ketoconazole topical foam product
✕. Patients with associated serious systemic diseases or immunocompromised patients

What they're measuring

Lesion count reduction

Timeframe: 90 days

Trial details

NCT IDNCT00824863

SponsorWayne Fujita, M.D.

Sponsor typeINDIV

Study typeINTERVENTIONAL

Primary completion2010-05

View on ClinicalTrials.gov More Pityrosporum Folliculitis trials