Three-Arm Trial of Novel Treatment for Tinea Pedis

Tinea Pedis Clinical Trial

Official title:

Three-Arm Trial of Novel Treatment for Tinea Pedis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03135912
• Other study ID #: SESK-001
• Status: Completed
• Phase: Phase 2
• First received: December 20, 2016
• Last updated: October 5, 2017
• Start date: January 3, 2017
• Est. completion date: August 2, 2017

Study information

• Verified date: October 2017
• Source: South End Skin Care
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: August 2, 2017
• Est. primary completion date: August 2, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Tinea
• Tinea Pedis

Intervention

Drug:
• Experimental Drug SESC 01
Topical experimental treatment comprising a combination of approved topical therapies and a new dosage method.
• Placebo
Dosage method of SESC 01, without active ingredients.
• Terbinafine Hydrochloride
Topical terbinafine hydrochloride cream.

Locations

Country	Name	City	State
United States	Kuchnir Dermatology & Dermatologic Surgery	Milford	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
South End Skin Care

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Effective Treatment (Mycological Cure and Minimal Symptoms)	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.	6 weeks
Secondary	Rate of Adverse Events	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.	6 weeks
Secondary	Effective Treatment (Mycological Cure and Minimal Symptoms)	Effective treatment as defined above, but measured at the end of treatment (4 weeks after the beginning of participation).	4 weeks
Secondary	Patient Satisfaction Score	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 weeks
Secondary	Self-Reported Patient Compliance	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.	4 weeks