Safety and Efficacy of Ketoconazole 2% Foam in the Treatment of Pityrosporum Folliculitis
Primary Purpose
Pityrosporum Folliculitis
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
ketoconazole 2% foam
Sponsored by
About this trial
This is an interventional treatment trial for Pityrosporum Folliculitis focused on measuring pityrosporum folliculitis, ketoconazole 2% foam
Eligibility Criteria
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
Sites / Locations
- Aiea Medical Building; Suite 401
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
one arm
Arm Description
All 10 patients receive ketoconazole 2% foam in the uncontrolled study.
Outcomes
Primary Outcome Measures
Lesion count reduction
Secondary Outcome Measures
Patient will be questioned on global assessment regarding response to treatment.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00824863
Brief Title
Safety and Efficacy of Ketoconazole 2% Foam in the Treatment of Pityrosporum Folliculitis
Official Title
An Open-Label, Proof of Concept Study to Determine the Safety and Efficacy of Ketoconazole 2% Foam in the Treatment of Pityrosporum Folliculitis
Study Type
Interventional
2. Study Status
Record Verification Date
August 2014
Overall Recruitment Status
Completed
Study Start Date
December 2008 (undefined)
Primary Completion Date
May 2010 (Actual)
Study Completion Date
June 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Wayne Fujita, M.D.
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
Detailed Description
Malassezia/pityrosporum species is a ubiquitous saprophyte of human skin. This organism is implicated in the etiology of seborrheic dermatitis, tinea versicolor, and pityrosporum folliculitis. The prevalence of pityrosporum folliculitis is especially high in warm and humid environments, although its presence is universal. Pityrosporum folliculitis presents in immuno-competent, acne-prone young adults as fine superficial follicular pustules and papules on the trunk and upper extremities. There are no comedones. This acneiform condition is non-scarring. It causes significant morbidity for patients as it is frequently mistaken for acne vulgaris with scarring potential, often associated with pruritis, and fails to respond to adequate conventional acne treatment- systemic antibiotics, topical benzoyl peroxide, and topical retinoids. Pityrosporum folliculitis can be the sole presenting condition or it can coexist with acne vulgaris. Less commonly, patients with pityrosporum folliculitis present with associated tinea versicolor and seborrheic dermatitis. The diagnosis is made by clinical presentation, microscopic examination for the pustule for spores/hyphae, skin biopsy, and retrospectively following good response to antimycotic therapy.
Ketoconazole 2% foam was recently approved for the treatment of seborrheic dermatitis in immunocompetent patients 12 years and older. Safety and efficacy of ketoconazole 2% foam treatment for pityrosporum folliculitis has not been established. Prior to the availability of the ketoconazole 2% foam, successful treatment of pityrosporum folliculitis required systemic anti fungal drugs such as ketoconazole, itraconazole and fluconazole. It also responds to oral isotretinoin. Systemic antimycotics are effective but repeated use of these drugs incurs safety concerns including hepatotoxicity and drug-drug interactions. Oral isotretinoin is indicated for severe nodulo-cystic acne and generally is inappropriate as a routine treatment modality for pityrosporum folliculitis. As pityrosporum folliculitis is a non-scarring acneiform condition and can be recurrent, effective and safe, patient initiated topical treatment would be a more appropriate form of therapy.The objective of this study is to demonstrate that ketoconazole 2% foam may be the treatment of choice for pityrosporum folliculitis.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pityrosporum Folliculitis
Keywords
pityrosporum folliculitis, ketoconazole 2% foam
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Actual)
8. Arms, Groups, and Interventions
Arm Title
one arm
Arm Type
Experimental
Arm Description
All 10 patients receive ketoconazole 2% foam in the uncontrolled study.
Intervention Type
Drug
Intervention Name(s)
ketoconazole 2% foam
Other Intervention Name(s)
ketaconozole 2% foam brand name is Extina Foam.
Intervention Description
topical antifungal foam to be applied to the folliculitis BID for 2-4 weeks.
Primary Outcome Measure Information:
Title
Lesion count reduction
Time Frame
90 days
Secondary Outcome Measure Information:
Title
Patient will be questioned on global assessment regarding response to treatment.
Time Frame
90 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wayne H. Fujita, M.D.
Organizational Affiliation
Private Practice
Official's Role
Principal Investigator
Facility Information:
Facility Name
Aiea Medical Building; Suite 401
City
Aiea
State/Province
Hawaii
ZIP/Postal Code
96701
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Safety and Efficacy of Ketoconazole 2% Foam in the Treatment of Pityrosporum Folliculitis
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