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Three-Arm Trial of Novel Treatment for Tinea Pedis

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ClinicalTrials.gov Identifier: NCT03135912
Recruitment Status : Completed
First Posted : May 2, 2017
Last Update Posted : October 6, 2017
Sponsor:
Information provided by (Responsible Party):
South End Skin Care

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.

Condition or disease Intervention/treatment Phase
Tinea Pedis Drug: Experimental Drug SESC 01 Drug: Placebo Drug: Terbinafine Hydrochloride Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Three-Arm Trial of Novel Treatment for Tinea Pedis
Actual Study Start Date : January 3, 2017
Actual Primary Completion Date : August 2, 2017
Actual Study Completion Date : August 2, 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Experimental Treatment
Patients supplied with Experimental Drug SESC 01 for daily topical therapy for 4 weeks.
Drug: Experimental Drug SESC 01
Topical experimental treatment comprising a combination of approved topical therapies and a new dosage method.

Placebo Comparator: Vehicle Control
Patients supplied with inactive vehicle (placebo), identical to experimental treatment but without active ingredients, to be applied daily for 4 weeks.
Drug: Placebo
Dosage method of SESC 01, without active ingredients.

Active Comparator: Active Comparator
Terbinafine hydrochloride cream, to be applied twice daily for 4 weeks.
Drug: Terbinafine Hydrochloride
Topical terbinafine hydrochloride cream.
Other Name: Lamisil AT




Primary Outcome Measures :
  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 Outcome Measures :
  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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

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): NCT03135912


Locations
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United States, Massachusetts
Kuchnir Dermatology & Dermatologic Surgery
Milford, Massachusetts, United States, 01757
Sponsors and Collaborators
South End Skin Care
Investigators
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Principal Investigator: Carl Schanbacher, MD South End Skin Care

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Responsible Party: South End Skin Care
ClinicalTrials.gov Identifier: NCT03135912     History of Changes
Other Study ID Numbers: SESK-001
First Posted: May 2, 2017    Key Record Dates
Last Update Posted: October 6, 2017
Last Verified: October 2017

Keywords provided by South End Skin Care:
Tinea Pedis
Athlete's Foot

Additional relevant MeSH terms:
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Terbinafine
Tinea
Tinea Pedis
Dermatomycoses
Skin Diseases, Infectious
Infection
Mycoses
Skin Diseases
Foot Dermatoses
Foot Diseases
Pruritus
Skin Manifestations
Signs and Symptoms
Antifungal Agents
Anti-Infective Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action