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Ketoconazole Foam 2% for the Treatment of Versicolor

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ClinicalTrials.gov Identifier: NCT00830388
Recruitment Status : Completed
First Posted : January 27, 2009
Results First Posted : August 22, 2012
Last Update Posted : August 22, 2012
Sponsor:
Information provided by (Responsible Party):
Boni Elewski, MD, University of Alabama at Birmingham

Brief Summary:
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 or disease Intervention/treatment Phase
Tinea Versicolor Drug: Ketoconazole 2% Foam Phase 4

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.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 11 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Ketoconazole Foam 2% for the Treatment of Versicolor
Study Start Date : November 2008
Actual Primary Completion Date : August 2010
Actual Study Completion Date : September 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tinea Infections
U.S. FDA Resources

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. The Effect of Ketoconazole 2% Foam for the Treatment of Tinea Versicolor [ Time Frame: 4 weeks ]
    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 :
  1. 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 ]
    Adverse events were used to assess safety.



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Ages Eligible for Study:   19 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Boni Elewski, MD, Principal Investigator, University of Alabama at Birmingham
ClinicalTrials.gov Identifier: NCT00830388     History of Changes
Other Study ID Numbers: F080520002
First Posted: January 27, 2009    Key Record Dates
Results First Posted: August 22, 2012
Last Update Posted: August 22, 2012
Last Verified: July 2012

Keywords provided by Boni Elewski, MD, University of Alabama at Birmingham:
tinea versicolor
ketoconazole

Additional relevant MeSH terms:
Tinea Versicolor
Dermatomycoses
Skin Diseases, Infectious
Infection
Mycoses
Skin Diseases
Ketoconazole
Antifungal Agents
Anti-Infective Agents
14-alpha Demethylase Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Steroid Synthesis Inhibitors
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Cytochrome P-450 CYP3A Inhibitors