Ketoconazole Foam 2% for the Treatment of Versicolor

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Boni Elewski, MD, University of Alabama at Birmingham
ClinicalTrials.gov Identifier:
NCT00830388
First received: January 23, 2009
Last updated: August 21, 2012
Last verified: July 2012
  Purpose

Ten adult patients age 19 and older with a clinical diagnosis of tinea versicolor, as well as a positive Potassium Hydroxide (KOH) using calcofluor. Ketoconazole 2% foam will be used to determine its effectiveness, safety and satisfaction when used to treat tinea versicolor.


Condition Intervention Phase
Tinea Versicolor
Drug: Ketoconazole 2% Foam
Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Ketoconazole Foam 2% for the Treatment of Versicolor

Resource links provided by NLM:


Further study details as provided by University of Alabama at Birmingham:

Primary Outcome Measures:
  • The Effect of Ketoconazole 2% Foam for the Treatment of Tinea Versicolor [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
    Eleven participants were tested for the microscopic presence of yeast. At four weeks, all participants were re-tested and deemed positive if yeast continued to be present microscopically.


Secondary Outcome Measures:
  • To Assess the Safety of Ketoconazole 2% Foam for the Treatment of Tinea Versicolor Based on the Occurrence of Adverse Events. [ Time Frame: 4 weeks ] [ Designated as safety issue: Yes ]
    Adverse events were used to assess safety.


Enrollment: 11
Study Start Date: November 2008
Study Completion Date: September 2010
Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Ketoconazole 2% Foam
Open-label study
Drug: Ketoconazole 2% Foam
Ketoconazole 2% Foam, twice daily application to affected areas for 4 weeks.
Other Name: Extina Foam

Detailed Description:

Objectives

  1. To assess the efficacy of ketoconazole 2% foam for the treatment of tinea versicolor
  2. To assess the safety of ketoconazole 2% foam for the treatment of tinea versicolor based on the occurrence of adverse events.
  3. To assess treatment satisfaction as rated by patients

Study Design:

This will be a mono-centered, single arm, open-label pilot study. Ten adult patients age 19 and older with a clinical diagnosis of tinea versicolor, as well as a positive KOH using calcofluor, will be enrolled at the University of Alabama at Birmingham. There will be 4 scheduled visits (baseline, week 1, week 2, and week 4). A target area will be identified and mycological and clinical assessments will be performed at this site as well as a global assessment of each subject. Ketoconazole 2% foam will be applied to all affected areas for 2 weeks with a follow-up visit at week 4. Skin scraping using a disposable #15 blade for calcofluor/potassium hydroxide (KOH) assessment and photographs of target lesions will be performed at baseline, week 1, week 2, and week 4. Photographs will be taken at baseline and at week 4 (only if KOH is positive). Body surface area estimation of disease will also be performed at each visit. Evaluation of scale, hyperpigmentation/erythema, and hypopigmentation using a 4 point scale (0 = none, 1 = mild, 2 = moderate, 3 = severe) of the target area will be performed at baseline, week 1, week 2, and week 4. A global assessment will be conducted at each visit using the same 4 point scale. Patient questionnaires will be administered at baseline and week 2 to assess symptoms and satisfaction with study medication.

  Eligibility

Ages Eligible for Study:   19 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Male or female patients, aged 19 years and over.
  2. Clinical presentation of tinea versicolor.
  3. Positive KOH using calcofluor.
  4. The ability to provide informed consent (including photography release)

Exclusion Criteria:

  1. Use of topical antifungal to the affected area in the past 30 days
  2. Use of topical steroid to the affected area in the past 14 days
  3. If female, positive urine pregnancy test at screening (female patients of childbearing potential must be practicing a reliable method of birth control, not be planning a pregnancy, not be breast-feeding during the study)
  4. Patients with a dermatologic condition in the region of the treatment site that in the investigator's opinion may interfere with the study results
  5. Current diagnosis of immunocompromising conditions
  6. Any medical or psychiatric condition that may interfere with treatment or compliance
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00830388

Locations
United States, Alabama
UAB Dermatology
Birmingham, Alabama, United States, 35233
Sponsors and Collaborators
Boni Elewski, MD
Investigators
Principal Investigator: Boni E Elewski, MD University of Alabama at Birmingham
  More Information

No publications provided

Responsible Party: Boni Elewski, MD, Principal Investigator, University of Alabama at Birmingham
ClinicalTrials.gov Identifier: NCT00830388     History of Changes
Other Study ID Numbers: F080520002
Study First Received: January 23, 2009
Results First Received: May 1, 2012
Last Updated: August 21, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by University of Alabama at Birmingham:
tinea versicolor
ketoconazole

Additional relevant MeSH terms:
Tinea
Tinea Versicolor
Dermatomycoses
Skin Diseases, Infectious
Infection
Mycoses
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 April 17, 2014