Efficacy and Safety of Product S2G6T-1in Patients With Symptomatic Inflammatory Interdigital Tine… (NCT02842021) | Clinical Trial Compass
TerminatedPhase 2
Efficacy and Safety of Product S2G6T-1in Patients With Symptomatic Inflammatory Interdigital Tinea Pedis
Stopped: Failed to meet success criteria
United States283 participantsStarted 2016-09
Plain-language 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.
Who can participate
Age range
12 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 .
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Complete cure at Day 29
Timeframe: Day 29
2
Reduction in Tinea pedis SymptomS through treatment period.
. 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.