Back to resultsThree-Arm Trial of Novel Treatment for Tinea Pedis
Primary Purpose
Tinea Pedis
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Experimental Drug SESC 01
Placebo
Terbinafine Hydrochloride
Sponsored by
About this trial
This is an interventional treatment trial for Tinea Pedis focused on measuring Tinea Pedis, Athlete's Foot
Eligibility 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
Sites / Locations
- Kuchnir Dermatology & Dermatologic Surgery
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Placebo Comparator
Active Comparator
Arm Label
Experimental Treatment
Vehicle Control
Active Comparator
Arm Description
Patients supplied with Experimental Drug SESC 01 for daily topical therapy for 4 weeks.
Patients supplied with inactive vehicle (placebo), identical to experimental treatment but without active ingredients, to be applied daily for 4 weeks.
Terbinafine hydrochloride cream, to be applied twice daily for 4 weeks.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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).
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.
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03135912
Brief Title
Three-Arm Trial of Novel Treatment for Tinea Pedis
Official Title
Three-Arm Trial of Novel Treatment for Tinea Pedis
Study Type
Interventional
2. Study Status
Record Verification Date
October 2017
Overall Recruitment Status
Completed
Study Start Date
January 3, 2017 (Actual)
Primary Completion Date
August 2, 2017 (Actual)
Study Completion Date
August 2, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
South End Skin Care
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tinea Pedis
Keywords
Tinea Pedis, Athlete's Foot
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
90 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Experimental Treatment
Arm Type
Experimental
Arm Description
Patients supplied with Experimental Drug SESC 01 for daily topical therapy for 4 weeks.
Arm Title
Vehicle Control
Arm Type
Placebo Comparator
Arm Description
Patients supplied with inactive vehicle (placebo), identical to experimental treatment but without active ingredients, to be applied daily for 4 weeks.
Arm Title
Active Comparator
Arm Type
Active Comparator
Arm Description
Terbinafine hydrochloride cream, to be applied twice daily for 4 weeks.
Intervention Type
Drug
Intervention Name(s)
Experimental Drug SESC 01
Intervention Description
Topical experimental treatment comprising a combination of approved topical therapies and a new dosage method.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Dosage method of SESC 01, without active ingredients.
Intervention Type
Drug
Intervention Name(s)
Terbinafine Hydrochloride
Other Intervention Name(s)
Lamisil AT
Intervention Description
Topical terbinafine hydrochloride cream.
Primary Outcome Measure Information:
Title
Effective Treatment (Mycological Cure and Minimal Symptoms)
Description
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.
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
Rate of Adverse Events
Description
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.
Time Frame
6 weeks
Title
Effective Treatment (Mycological Cure and Minimal Symptoms)
Description
Effective treatment as defined above, but measured at the end of treatment (4 weeks after the beginning of participation).
Time Frame
4 weeks
Title
Patient Satisfaction Score
Description
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.
Time Frame
4 weeks
Title
Self-Reported Patient Compliance
Description
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.
Time Frame
4 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Carl Schanbacher, MD
Organizational Affiliation
South End Skin Care
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kuchnir Dermatology & Dermatologic Surgery
City
Milford
State/Province
Massachusetts
ZIP/Postal Code
01757
Country
United States
12. IPD Sharing Statement
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Three-Arm Trial of Novel Treatment for Tinea Pedis
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