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

NCT00824863 | Completed Phase 4 DMC

• 1 other identifier: U0275-502
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Pityrosporum Folliculitis

Keywords

pityrosporum folliculitis; ketoconazole 2% foam

Outcome Measures

Primary Outcomes (1)

• Lesion count reduction

  90 days

Secondary Outcomes (1)

• Patient will be questioned on global assessment regarding response to treatment.

  90 days

Study Arms (1)

one arm

EXPERIMENTAL

All 10 patients receive ketoconazole 2% foam in the uncontrolled study.

Drug: ketoconazole 2% foam

Interventions

ketoconazole 2% foam DRUG

topical antifungal foam to be applied to the folliculitis BID for 2-4 weeks.

Also known as: ketaconozole 2% foam brand name is Extina Foam.

one arm

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Wayne Fujita, M.D.: lead

Study Sites (1)

Aiea Medical Building; Suite 401

‘Aiea, Hawaii, 96701, United States

Location

MeSH Terms

Interventions

Ketoconazole

Intervention Hierarchy (Ancestors)

Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Wayne H. Fujita, M.D.

  Private Practice

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDIV
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 15, 2009
• First Posted: January 19, 2009
• Study Start: December 1, 2008
• Primary Completion: May 1, 2010
• Study Completion: June 1, 2010
• Last Updated: August 21, 2014

Record last verified: 2014-08

Locations

US (1)