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

• Status: Completed
• Trial end date: 2010-06-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Wayne Fujita, M.D.
• Treatments: Ketoconazole

Criteria

Inclusion Criteria:

1. 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.

2. Concomitant acne treatments with standard acne treatment modalities will be allowed - oral and topical antibiotics, topical retinoids, and benzoyl peroxides.

Exclusion Criteria:

1. Pregnancy and breast feeding

2. Patients with nodulocystic acne on the trunk

3. Current or prior treatment with oral isotretinoin

4. Patients allergic to the ketoconazole topical foam product

5. Patients with associated serious systemic diseases or immunocompromised patients