Study Stopped
Failed to meet success criteria
Efficacy and Safety of Product S2G6T-1in Patients With Symptomatic Inflammatory Interdigital Tinea Pedis
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
1 other identifier
interventional
283
1 country
19
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Sep 2016
Shorter than P25 for phase_2
19 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 13, 2016
CompletedFirst Posted
Study publicly available on registry
July 22, 2016
CompletedStudy Start
First participant enrolled
September 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2017
CompletedNovember 18, 2020
November 1, 2020
1.1 years
July 13, 2016
November 15, 2020
Conditions
Outcome Measures
Primary Outcomes (2)
Complete cure at 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.
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
Study Arms (4)
S2G6T-1
ACTIVE COMPARATORTopical cream
S2G6T-2
ACTIVE COMPARATORTopical Cream
S2G6T-3
ACTIVE COMPARATORTopical Cream
S2G6T-4
PLACEBO COMPARATORTopical Cream
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
- +3 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (19)
TCR Medical Corporation
San Diego, California, 92123, United States
University Clinical Trials, Inc.
San Diego, California, 92123, United States
Tampa Bay Medical Research
Clearwater, Florida, 33761, United States
Tory Sullivan, MD, PA
North Miami Beach, Florida, 33162, United States
Park Avenue Dermatology
Orange Park, Florida, 32073, United States
Mid Atlantic Research for Health
Baltimore, Maryland, 21214, United States
Minnesota Clinical Study Center
Fridley, Minnesota, 55432, United States
Academic Dermatology Associates
Albuquerque, New Mexico, 87106, United States
Skin Search of Rochester, Inc.
Rochester, New York, 146232, United States
Tennessee Clinical Research Center
Nashville, Tennessee, 37215, United States
DermResearch, Inc.
Austin, Texas, 78759, United States
J&S Studies, Inc
College Station, Texas, 77845, United States
Suzanne Bruce & Associates, PA / The Center for Skin Research
Houston, Texas, 77056, United States
Suzanne Bruce & Associates ,PA / The Center for Skin Research
Katy, Texas, 77494, United States
DermResearch New Braunfels
New Braunfels, Texas, 78130, United States
Endeavor Clinical Trials, PA
San Antonio, Texas, 78229, United States
Dermatology Research Center, Inc.
Salt Lake City, Utah, 84117, United States
The Education & Research Foundation Inc.
Lynchburg, Virginia, 24501, United States
Virginia Clinical Research Inc.
Norfolk, Virginia, 23502, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Kathleen O Ashenfelter, MS
Cu-Tech, LLC
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 13, 2016
First Posted
July 22, 2016
Study Start
September 1, 2016
Primary Completion
October 1, 2017
Study Completion
October 1, 2017
Last Updated
November 18, 2020
Record last verified: 2020-11