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 range12 Years
SexALL
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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.
✕
What they're measuring
1
Complete cure at Day 29
Timeframe: Day 29
2
Reduction in Tinea pedis SymptomS through treatment period.