Three-Arm Trial of Novel Treatment for Tinea Pedis

NCT03135912 | Completed Phase 2

• 1 other identifier: SESK-001
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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.

Conditions

Tinea Pedis

Keywords

Tinea Pedis; Athlete's Foot

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Rate of Adverse Events

  6 weeks

• Effective Treatment (Mycological Cure and Minimal Symptoms)

  4 weeks

• Patient Satisfaction Score

  4 weeks

• Self-Reported Patient Compliance

  4 weeks

Study Arms (3)

Experimental Treatment

EXPERIMENTAL

Patients supplied with Experimental Drug SESC 01 for daily topical therapy for 4 weeks.

Drug: Experimental Drug SESC 01

Vehicle Control

PLACEBO COMPARATOR

Patients supplied with inactive vehicle (placebo), identical to experimental treatment but without active ingredients, to be applied daily for 4 weeks.

Drug: Placebo

Active Comparator

ACTIVE COMPARATOR

Terbinafine hydrochloride cream, to be applied twice daily for 4 weeks.

Drug: Terbinafine Hydrochloride

Interventions

Experimental Drug SESC 01 DRUG

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

Experimental Treatment

Placebo DRUG

Dosage method of SESC 01, without active ingredients.

Vehicle Control

Terbinafine Hydrochloride DRUG

Topical terbinafine hydrochloride cream.

Also known as: Lamisil AT

Active Comparator

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• South End Skin Care: lead

Study Sites (1)

Kuchnir Dermatology & Dermatologic Surgery

Milford, Massachusetts, 01757, United States

Location

MeSH Terms

Conditions

Tinea Pedis

Interventions

Terbinafine

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds

Study Officials

• Carl Schanbacher, MD

  South End Skin Care

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 20, 2016
• First Posted: May 2, 2017
• Study Start: January 3, 2017
• Primary Completion: August 2, 2017
• Study Completion: August 2, 2017
• Last Updated: October 6, 2017

Record last verified: 2017-10

Locations

US (1)