Clinical Trial: Three-Arm Trial of Novel Treatment for Tinea Pedis

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Three-Arm Trial of Novel Treatment for Tinea Pedis

Brief Summary: This is a three-arm randomized controlled trial to assess the efficacy of an experimental treatment in the treatment of tinea pedis (athlete's foot). The experimental treatment will be tested against a vehicle control to determine efficacy and safety, and against an active comparator to evaluate the success of the treatment relative to an existing gold-standard treatment. Patients will be treated for four weeks, with their condition being assessed at the end of treatment and two weeks after the end of treatment. The primary endpoint for this study is effective treatment rate at the week 6 evaluation, defined as a mycological cure and minimal clinical signs & symptoms. Secondary endpoints include safety and patient evaluation of treatment.

Detailed Summary:
Sponsor: South End Skin Care

Current Primary Outcome: Effective Treatment (Mycological Cure and Minimal Symptoms) [ Time Frame: 6 weeks ]

Binary outcome measure defined as mycological cure AND a total clinical assessment score less than or equal to 2 (out of a possible 18). Mycological cure is defined as negative potassium hydroxide microscopy, while the clinical assessment is based on a sum of 6 symptoms (desquamation, vesiculation, erythema, fissuring, maceration, and pruritus) scored 0-3 by a physician.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Rate of Adverse Events [ Time Frame: 6 weeks ]
    To examine treatment safety, we will calculate the rate of adverse events and serious adverse and compare them between the study's three arms using Chi-square tests to evaluate whether a statistically significant difference is present.
  • Effective Treatment (Mycological Cure and Minimal Symptoms) [ Time Frame: 4 weeks ]
    Effective treatment as defined above, but measured at the end of treatment (4 weeks after the beginning of participation). This ind
  • Patient Satisfaction Score [ Time Frame: 4 weeks ]
    At the conclusion of treatment, patients complete a brief survey on their impressions of the treatment's tolerability, effectiveness, and convenience on a five-point scale, where 1 = poor, 2 = fair, 3 = good, 4 = very good, 5 = excellent, or they may answer with "No answer/prefer not to say". Scores will be compared for each of the three characteristics and as a sum of the three scores.
  • Self-Reported Patient Compliance [ Time Frame: 4 weeks ]
    On the same experience questionnaire, patients are asked to estimate how many doses of treatment they missed or forgot to take. Possible answers are None, 1-2, 3-4, 5-6, 7-8, or 9 or more. This indicates whether there is a significant difference in patients' likelihood to adhere to a treatment regimen.


Original Secondary Outcome: Same as current

Information By: South End Skin Care

Dates:
Date Received: December 20, 2016
Date Started: December 2016
Date Completion: June 2017
Last Updated: April 26, 2017
Last Verified: April 2017