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NCT03135912 · ClinicalTrials.gov registry record · Phase 2
Three-Arm Trial of Novel Treatment for Tinea Pedis
A Phase 2 study of Tinea Pedis, sponsored by South End Skin Care.
- Completed
- Registry status
- Phase 2
- Development phase
- 90
- Enrollment target
- 1
- Study location
NCT03135912: Completed Phase 2 study of Tinea Pedis, sponsored by South End Skin Care.
NCT03135912 is a Phase 2 study of Tinea Pedis that has completed, run by South End Skin Care. The registered enrollment target is 90 participants, below the 317-participant average among 9 other Tinea Pedis trials with a reported enrollment target (72% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03135912, a Phase 2 study of Tinea Pedis, has completed, sponsored by South End Skin Care.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 90 participants
- Enrollment target
- 1
- Study location
Study Summary
This is a three-arm randomized controlled trial to assess the efficacy of an experimental treatment in the treatment of tinea pedis (athlete's foot). The experimental treatment will be tested against a vehicle control to determine efficacy and safety, and against an active comparator to evaluate the success of the treatment relative to an existing gold-standard treatment. Patients will be treated for four weeks, with their condition being assessed at the end of treatment and two weeks after the end of treatment. The primary endpoint for this study is effective treatment rate at the week 6 evaluation, defined as a mycological cure and minimal clinical signs \& symptoms. Secondary endpoints include safety and patient evaluation of treatment.
Primary Outcome
Binary outcome measure defined as mycological cure AND a total clinical assessment score less than or equal to 2 (out of a possible 18). Mycological cure is defined as negative potassium hydroxide microscopy, while the clinical assessment is based on a sum of 6 symptoms (desquamation, vesiculation, erythema, fissuring, maceration, and pruritus) scored 0-3 by a physician.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Terbinafine Hydrochloride
- DRUG Experimental Drug SESC 01
Study Locations (1)
Massachusetts
- Kuchnir Dermatology & Dermatologic Surgery - Milford
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 90 participants |
| Start Date | 2017-01-03 |
| Est. Completion | 2017-08-02 |
| Phase | Phase 2 |
What the finished NCT03135912 record still lists
NCT03135912 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 90 participants, a relatively small participant target, below the 317-participant average among 9 other Tinea Pedis trials with a reported enrollment target (72% lower).
The record links to 1 condition, with Tinea Pedis appearing as the primary indexed condition, and to 3 interventions - of which Placebo is the first listed.
NCT03135912 reports a single indexed study location in Massachusetts.
Frequently Asked Questions
What is clinical trial NCT03135912 about?
NCT03135912 is a clinical study titled "Three-Arm Trial of Novel Treatment for Tinea Pedis". This is a three-arm randomized controlled trial to assess the efficacy of an experimental treatment in the treatment of tinea pedis (athlete's foot). The experimental treatment will be tested against a vehicle control to determine efficacy and safety, and against an active comparator to evaluate the...
What is the current status of trial NCT03135912?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 90 participants. The study started on 2017-01-03. Estimated completion is 2017-08-02.
What conditions does trial NCT03135912 study?
This clinical trial studies the following conditions: Tinea Pedis.
What interventions are being tested in trial NCT03135912?
The interventions under investigation include: Placebo (DRUG), Terbinafine Hydrochloride (DRUG), Experimental Drug SESC 01 (DRUG).
Who is sponsoring clinical trial NCT03135912?
This trial is sponsored by South End Skin Care, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03135912 being conducted?
This trial has 1 study location across Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Tinea Pedis
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT03135912's enrollment target sits among peer trials
90 8th of 9 higher than 2 of 9 other Tinea Pedis trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Tinea Pedis trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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