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

Completed · Phase 4

Conditions studied: Pityrosporum Folliculitis

In brief

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.

Key facts

Study ID

NCT00824863

Run by

Wayne Fujita, M.D.

People needed

10

Starts

2008-12-01

Expected to finish

2010-06-01

Last updated by the study team

2014-08-21

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• Aiea Medical Building; Suite 401 — ‘Aiea, Hawaii, United States

Full record on ClinicalTrials.gov

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