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Completed

NCT Number: NCT03135912

Three-Arm Trial of Novel Treatment for Tinea Pedis

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.

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Key information

Conditions

Tinea Pedis Bacterial Infections and Mycoses Dermatomycoses Foot Dermatoses Foot Diseases Infections Mycoses Pathological Conditions, Signs and Symptoms Pruritus Signs and Symptoms Skin Diseases Skin Diseases, Infectious Skin Manifestations Skin and Connective Tissue Diseases Tinea

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Kuchnir Dermatology & Dermatologic Surgery

Milford, Massachusetts, 01757, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • male or female, aged 18 or above
  • clinical diagnosis of tinea pedis
  • diagnosis confirmed with potassium hydroxide microscopy
  • availability for the duration of the study (6 weeks)
  • willingness to comply with study protocol
  • informed consent

Exclusion criteria

  • moccasin-type tinea pedis
  • severe maceration of interdigital spaces
  • severe fissuring
  • history of dry feet, cracking, fissuring
  • concurrent onychomycosis
  • serous exudate or pus
  • topical antifungal treatment in the past 2 weeks
  • systemic antifungal treatment in the past 4 weeks
  • concurrent immunosuppressive or antimicrobial therapy
  • liver disease
  • pregnancy or breastfeeding
  • known hypersensitivity to any ingredients of trial agents

Treatment and study plan

Experimental Drug SESC 01

Drug

Topical experimental treatment comprising a combination of approved topical therapies and a new dosage method.

Placebo

Drug

Dosage method of SESC 01, without active ingredients.

Terbinafine hydrochloride

Drug

Topical terbinafine hydrochloride cream.

Other names: Lamisil AT

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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).

  3. 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.

  4. 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.

Sponsors and collaborators

Lead sponsor

South End Skin Care

Industry

Registry information

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
May 2, 2017
Registry last updated
Oct 6, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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