Efficacy and Safety of Product S2G6T-1in Patients With Symptomatic Inflammatory Interdigital Tinea Pedis
NCT ID: NCT02842021
Last Updated: 2020-11-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE2
283 participants
INTERVENTIONAL
2016-09-30
2017-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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S2G6T-1
Topical cream
S2G6T-1
Twice a day topical cream
S2G6T-2
Topical Cream
S2G6T-2
Twice a day topical cream
S2G6T-3
Topical Cream
S2G6T-3
Twice a day topical cream
S2G6T-4
Topical Cream
S2G6T-4
Twice a day topical cream
Interventions
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S2G6T-1
Twice a day topical cream
S2G6T-2
Twice a day topical cream
S2G6T-3
Twice a day topical cream
S2G6T-4
Twice a day topical cream
Eligibility Criteria
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Inclusion Criteria
2. Male or Female subjects 12 years of age or older.
3. A clinical diagnosis of interdigital tinea pedis on one or both feet characterized by clinical evidence of a tinea infection.
4. 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.
5. Mycological evidence of the presence of fungi confirmed by the detection of fungal hyphae on a microscopic KOH wet mount.
6. 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 .
7. 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.
8. Must be able to communicate, be able to understand the study procedures, and be willing to comply with the study requirements.
Exclusion Criteria
2. Negative KOH microscopy test to assess presence of hyphae.
3. Onychomycosis of the toenails, involving ≥ 20% of the area of either great toenail or involvement of more than five toenails in total.
4. Concurrent tinea infection or bacterial skin infection on the feet.
5. Female subjects who are pregnant and/or nursing or planning a pregnancy during the course of the trial.
6. Recent history of or currently known to abuse drugs or alcohol.
7. History of intolerance or hypersensitivity to Econazole Nitrate, Mometasone Furoate, or other imidazole agents.
8. Presence of any other infection of the foot or other disease process that might confound the treatment evaluation.
9. Having a life-threatening condition or immunocompromised (e.g., autoimmune deficiency syndrome, cancer, unstable angina, or myocardial infarction) within the last 6 months.
10. Unable to communicate or cooperate with the investigator due to language barriers, poor mental development, or impaired cerebral function.
11. Current participation in a clinical drug research study or recent participation in a clinical trial within 30 days of Baseline.
12. Using the following medications prior to Baseline:
1. Antipruritics, including antihistamines within 3 days (72 hours).
2. Topical corticosteroids, antibiotics or antifungal therapies within 4 weeks.
3. Systemic corticosteroids, antibiotics or antifungal therapies within 12 weeks.
4. Oral terbinafine or itraconazole within 12 weeks.
5. Immunosuppressive medication or radiation therapy within 12 weeks.
6. Any other topical medicated topical treatments to the treatment area(s) within 7 days.
\-
12 Years
ALL
No
Sponsors
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Sol-Gel Technologies, Ltd.
INDUSTRY
Responsible Party
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Principal Investigators
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Kathleen O Ashenfelter, MS
Role: STUDY_CHAIR
Cu-Tech, LLC
Locations
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TCR Medical Corporation
San Diego, California, United States
University Clinical Trials, Inc.
San Diego, California, United States
Tampa Bay Medical Research
Clearwater, Florida, United States
Tory Sullivan, MD, PA
North Miami Beach, Florida, United States
Park Avenue Dermatology
Orange Park, Florida, United States
Mid Atlantic Research for Health
Baltimore, Maryland, United States
Minnesota Clinical Study Center
Fridley, Minnesota, United States
Academic Dermatology Associates
Albuquerque, New Mexico, United States
Skin Search of Rochester, Inc.
Rochester, New York, United States
Tennessee Clinical Research Center
Nashville, Tennessee, United States
DermResearch, Inc.
Austin, Texas, United States
J&S Studies, Inc
College Station, Texas, United States
Suzanne Bruce & Associates, PA / The Center for Skin Research
Houston, Texas, United States
Suzanne Bruce & Associates ,PA / The Center for Skin Research
Katy, Texas, United States
DermResearch New Braunfels
New Braunfels, Texas, United States
Endeavor Clinical Trials, PA
San Antonio, Texas, United States
Dermatology Research Center, Inc.
Salt Lake City, Utah, United States
The Education & Research Foundation Inc.
Lynchburg, Virginia, United States
Virginia Clinical Research Inc.
Norfolk, Virginia, United States
Countries
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Other Identifiers
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SGT-26-01
Identifier Type: -
Identifier Source: org_study_id