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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Wayne Fujita, M.D., Fujita, Wayne, M.D.
ClinicalTrials.gov Identifier:
NCT00824863
First received: January 15, 2009
Last updated: March 6, 2014
Last verified: March 2014
  Purpose

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.


Condition Intervention Phase
Pityrosporum Folliculitis
Drug: ketoconazole 2% foam
Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Fujita, Wayne, M.D.:

Primary Outcome Measures:
  • Lesion count reduction [ Time Frame: 90 days ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Patient will be questioned on global assessment regarding response to treatment. [ Time Frame: 90 days ] [ Designated as safety issue: Yes ]

Enrollment: 10
Study Start Date: December 2008
Study Completion Date: June 2010
Primary Completion Date: May 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: one arm
All 10 patients receive ketoconazole 2% foam in the uncontrolled study.
Drug: ketoconazole 2% foam
topical antifungal foam to be applied to the folliculitis BID for 2-4 weeks.
Other Name: ketaconozole 2% foam brand name is Extina Foam.

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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00824863

Locations
United States, Hawaii
Aiea Medical Building; Suite 401
Aiea, Hawaii, United States, 96701
Sponsors and Collaborators
Wayne Fujita, M.D.
Investigators
Principal Investigator: Wayne H. Fujita, M.D. Private practice
  More Information

No publications provided

Responsible Party: Wayne Fujita, M.D., Principal Investigator, Fujita, Wayne, M.D.
ClinicalTrials.gov Identifier: NCT00824863     History of Changes
Other Study ID Numbers: U0275-502
Study First Received: January 15, 2009
Last Updated: March 6, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Fujita, Wayne, M.D.:
pityrosporum folliculitis
ketoconazole 2% foam

Additional relevant MeSH terms:
Folliculitis
Hair Diseases
Skin Diseases
Ketoconazole
14-alpha Demethylase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antifungal Agents
Anti-Infective Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on July 26, 2014