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NCT00824863

An Open-Label, Proof of Concept Study to Determine the Safety and Efficacy of Ketoconazole 2% Foam in the Treatment of Pityrosporum Folliculitis

Completed Phase 4 Last updated 19 August 2014
What this trial tests

Phase 4 trial testing ketoconazole 2% foam in Pityrosporum Folliculitis in 10 participants. Completed in 1 June 2010.

Timeline
1 December 2008
Primary endpoint
1 May 2010
1 June 2010

Quick facts

Lead sponsorWayne Fujita, M.D.
PhasePhase 4
StatusCompleted
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposetreatment
Enrollment10
Start date1 December 2008
Primary completion1 May 2010
Estimated completion1 June 2010
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

Wayne Fujita, M.D. — full company profile →

Who can join

Adults 18 to 65, any sex, with Pityrosporum Folliculitis. Healthy volunteers can join.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

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