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NCT03973775 · ClinicalTrials.gov registry record · Phase 3
A Bioequivalence Study With Clinical Endpoints to Evaluate the Safety and Therapeutic Equivalence of Permethrin Cream 5% & Elimite™ in Subjects With Scabies
A Phase 3 study of Scabies, sponsored by Saptalis Pharmaceuticals.
- Completed
- Registry status
- Phase 3
- Development phase
- 126
- Enrollment target
- 5
- Study locations
NCT03973775: Completed Phase 3 study of Scabies, sponsored by Saptalis Pharmaceuticals.
NCT03973775 is a Phase 3 study of Scabies that has completed, run by Saptalis Pharmaceuticals. The registered enrollment target is 126 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (84% lower). The trial reports 5 study locations across 3 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03973775, a Phase 3 study of Scabies, has completed, sponsored by Saptalis Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 126 participants
- Enrollment target
- 5
- Study locations
Study Summary
This phase III study was conducted to establish the clinical bioequivalence of Permethrin Cream 5% and Elimite™ in the treatment of scabies following a single application.
Primary Outcome
Cure is defined as demonstration of clinical cure (all clinical findings have completely resolved, including inflammatory/non-inflammatory lesions) and microscopic cure (demonstration of the absence of mites, ova, and/or mite feces) on Day 28. Negative microscopy can be declared if no mites, ova, or mite feces is found from a minimum of 3 skin scrapings from previously affected sites.
Conditions Studied
Interventions
- DRUG Permethrin Cream 5%
Study Locations (5)
California
- Universal Biopharma Research Institute Inc. - Dinuba
- Long Beach Clinical Trials Services, Inc. - Long Beach
- Havana Research Institute - Pasadena
Florida
- SouthCoast Research Center, Inc (Clinical Site & Drug Shipment Facility) - Miami
Texas
- West Houston Clinical Research Service - Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 126 participants |
| Start Date | 2018-04-10 |
| Est. Completion | 2018-12-06 |
| Phase | Phase 3 |
What the finished NCT03973775 record still lists
NCT03973775 is an interventional study that assigns participants to a tested intervention. The registered 126 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (84% lower).
The record links to 1 condition, with Scabies appearing as the primary indexed condition, and to 1 intervention - of which Permethrin Cream 5% is the first listed.
NCT03973775 lists 5 locations in 3 states (California, Florida, Texas).
Frequently Asked Questions
What is clinical trial NCT03973775 about?
NCT03973775 is a clinical study titled "A Bioequivalence Study With Clinical Endpoints to Evaluate the Safety and Therapeutic Equivalence of Permethrin Cream 5% & Elimite™ in Subjects With Scabies". This phase III study was conducted to establish the clinical bioequivalence of Permethrin Cream 5% and Elimite™ in the treatment of scabies following a single application.
What is the current status of trial NCT03973775?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 126 participants. The study started on 2018-04-10. Estimated completion is 2018-12-06.
What conditions does trial NCT03973775 study?
This clinical trial studies the following conditions: Scabies.
What interventions are being tested in trial NCT03973775?
The interventions under investigation include: Permethrin Cream 5% (DRUG).
Who is sponsoring clinical trial NCT03973775?
This trial is sponsored by Saptalis Pharmaceuticals, which has 2 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03973775 being conducted?
This trial has 5 study locations across California, Florida, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Scabies
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 NCT03973775's enrollment target sits among peer trials
126 1603rd of 2000 higher than 396 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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