Ketoconazole Foam 2% for the Treatment of Versicolor

NCT00830388 | Completed Phase 4 Results

• 1 other identifier: F080520002
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

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.

Conditions

Tinea Versicolor

Keywords

tinea versicolor; ketoconazole

Outcome Measures

Primary Outcomes (1)

• The Effect of Ketoconazole 2% Foam for the Treatment of Tinea Versicolor

  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.

  4 weeks

Secondary Outcomes (1)

• To Assess the Safety of Ketoconazole 2% Foam for the Treatment of Tinea Versicolor Based on the Occurrence of Adverse Events.

  4 weeks

Study Arms (1)

Ketoconazole 2% Foam

EXPERIMENTAL

Open-label study

Drug: Ketoconazole 2% Foam

Interventions

Ketoconazole 2% Foam DRUG

Ketoconazole 2% Foam, twice daily application to affected areas for 4 weeks.

Also known as: Extina Foam

Ketoconazole 2% Foam

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Use of topical antifungal to the affected area in the past 30 days
• Use of topical steroid to the affected area in the past 14 days
• 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)
• Patients with a dermatologic condition in the region of the treatment site that in the investigator's opinion may interfere with the study results
• Current diagnosis of immunocompromising conditions
• Any medical or psychiatric condition that may interfere with treatment or compliance

Sponsors & Collaborators

• Boni Elewski, MD: lead

Study Sites (1)

UAB Dermatology

Birmingham, Alabama, 35233, United States

Location

MeSH Terms

Conditions

Tinea Versicolor

Interventions

Ketoconazole

Condition Hierarchy (Ancestors)

Dermatomycoses; Mycoses; Bacterial Infections and Mycoses; Infections; Skin Diseases, Infectious; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Wendy Cantrell
• Organization: University of Alabama at Birmingham

wcantrell@uabmc.edu

205-502-9960

Study Officials

• Boni E Elewski, MD

  University of Alabama at Birmingham

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

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

Study Record Dates

• First Submitted: January 23, 2009
• First Posted: January 27, 2009
• Study Start: November 1, 2008
• Primary Completion: August 1, 2010
• Study Completion: September 1, 2010
• Last Updated: August 22, 2012
• Results First Posted: August 22, 2012

Record last verified: 2012-07

Locations

US (1)