- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02842021
Efficacy and Safety of Product S2G6T-1in Patients With Symptomatic Inflammatory Interdigital Tinea Pedis
November 15, 2020 updated by: Sol-Gel Technologies, Ltd.
A Randomized, Double-Blind, Active- and Vehicle-Controlled Study to Compare the Efficacy and Safety of Products S2G6T-1, S2G6T-2, S2G6T-3 and S2G6T-4 in Patients With Symptomatic Inflammatory Interdigital Tinea Pedis
To assess the efficacy and safety of a combination product S2G6T-1 compared to its monads and vehicle, applied twice daily for 7 days, in the treatment of symptomatic inflammatory interdigital tinea pedis in subjects 12 years of age and older.
The results of this study will be utilized to perform power calculations for the Phase 3 pivotal trials.
Study Overview
Status
Terminated
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
283
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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California
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San Diego, California, United States, 92123
- TCR Medical Corporation
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San Diego, California, United States, 92123
- University Clinical Trials, Inc.
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Florida
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Clearwater, Florida, United States, 33761
- Tampa Bay Medical Research
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North Miami Beach, Florida, United States, 33162
- Tory Sullivan, MD, PA
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Orange Park, Florida, United States, 32073
- Park Avenue Dermatology
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Maryland
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Baltimore, Maryland, United States, 21214
- Mid Atlantic Research for Health
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Minnesota
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Fridley, Minnesota, United States, 55432
- Minnesota Clinical Study Center
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New Mexico
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Albuquerque, New Mexico, United States, 87106
- Academic Dermatology Associates
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New York
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Rochester, New York, United States, 146232
- Skin Search of Rochester, Inc.
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Tennessee
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Nashville, Tennessee, United States, 37215
- Tennessee Clinical Research Center
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Texas
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Austin, Texas, United States, 78759
- Dermresearch, Inc.
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College Station, Texas, United States, 77845
- J&S Studies, Inc
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Houston, Texas, United States, 77056
- Suzanne Bruce & Associates, PA / The Center for Skin Research
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Katy, Texas, United States, 77494
- Suzanne Bruce & Associates ,PA / The Center for Skin Research
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New Braunfels, Texas, United States, 78130
- DermResearch New Braunfels
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San Antonio, Texas, United States, 78229
- Endeavor Clinical Trials, PA
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Utah
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Salt Lake City, Utah, United States, 84117
- Dermatology Research Center, Inc.
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Virginia
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Lynchburg, Virginia, United States, 24501
- The Education & Research Foundation Inc.
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Norfolk, Virginia, United States, 23502
- Virginia Clinical Research Inc.
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
10 years and older (Child, Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Ability and willingness to sign a written informed consent and /or assent (age appropriate).
- Male or Female subjects 12 years of age or older.
- A clinical diagnosis of interdigital tinea pedis on one or both feet characterized by clinical evidence of a tinea infection.
- A sum of at least five (5) for signs (erythema and scaling) by the investigator on the selected target foot, and a score of at least five (5) for each symptom: pruritus (itching) and burning: and a sum of at least twelve (12) for both symptoms (pruritus and burning) by the subject on the PATSS.
- Mycological evidence of the presence of fungi confirmed by the detection of fungal hyphae on a microscopic KOH wet mount.
- Females of child-bearing potential must have a negative urine pregnancy test and must agree to use an effective form of contraception during the study .
- Must be in good general health as determined by medical history and free of any disease that in the investigator's opinion might interfere with the study evaluations.
- Must be able to communicate, be able to understand the study procedures, and be willing to comply with the study requirements.
Exclusion Criteria:
- The presence of confluent diffuse moccasin-type tinea pedis.
- Negative KOH microscopy test to assess presence of hyphae.
- Onychomycosis of the toenails, involving ≥ 20% of the area of either great toenail or involvement of more than five toenails in total.
- Concurrent tinea infection or bacterial skin infection on the feet.
- Female subjects who are pregnant and/or nursing or planning a pregnancy during the course of the trial.
- Recent history of or currently known to abuse drugs or alcohol.
- History of intolerance or hypersensitivity to Econazole Nitrate, Mometasone Furoate, or other imidazole agents.
- Presence of any other infection of the foot or other disease process that might confound the treatment evaluation.
- Having a life-threatening condition or immunocompromised (e.g., autoimmune deficiency syndrome, cancer, unstable angina, or myocardial infarction) within the last 6 months.
- Unable to communicate or cooperate with the investigator due to language barriers, poor mental development, or impaired cerebral function.
- Current participation in a clinical drug research study or recent participation in a clinical trial within 30 days of Baseline.
Using the following medications prior to Baseline:
- Antipruritics, including antihistamines within 3 days (72 hours).
- Topical corticosteroids, antibiotics or antifungal therapies within 4 weeks.
- Systemic corticosteroids, antibiotics or antifungal therapies within 12 weeks.
- Oral terbinafine or itraconazole within 12 weeks.
- Immunosuppressive medication or radiation therapy within 12 weeks.
Any other topical medicated topical treatments to the treatment area(s) within 7 days.
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Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: S2G6T-1
Topical cream
|
Twice a day topical cream
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Active Comparator: S2G6T-2
Topical Cream
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Twice a day topical cream
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Active Comparator: S2G6T-3
Topical Cream
|
Twice a day topical cream
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Placebo Comparator: S2G6T-4
Topical Cream
|
Twice a day topical cream
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Complete cure at Day 29
Time Frame: Day 29
|
The primary efficacy comparison between S2G6T-1 vs. rest of study arms will be based on the percentage of subjects at day 29 with complete cure of interdigital tinea pedis.mycological
cure (i.e.
negative dermatophyte culture and negative KOH) and clinical cure (i.e.
absence of erythema, scaling and pruritus {scores of 0, each})
|
Day 29
|
Reduction in Tinea pedis SymptomS through treatment period.
Time Frame: Day 8
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comparison of Patient Assessment between S2G6T-1 vs. rest of study arms will be based on the percentage of subjects at day 8 with achieving decrease from baseline in the total score for pruritus and burning.
|
Day 8
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Chair: Kathleen O Ashenfelter, MS, Cu-Tech, LLC
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2016
Primary Completion (Actual)
October 1, 2017
Study Completion (Actual)
October 1, 2017
Study Registration Dates
First Submitted
July 13, 2016
First Submitted That Met QC Criteria
July 19, 2016
First Posted (Estimate)
July 22, 2016
Study Record Updates
Last Update Posted (Actual)
November 18, 2020
Last Update Submitted That Met QC Criteria
November 15, 2020
Last Verified
November 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- SGT-26-01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Undecided
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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