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NCT03732833 · ClinicalTrials.gov registry record · Phase 3
MT10109L in the Treatment of Lateral Canthal Lines With or Without Concurrent Treatment of Glabellar Lines
A Phase 3 study of Lateral Canthal Lines and Glabellar Lines, sponsored by Medy-Tox.
- Completed
- Registry status
- Phase 3
- Development phase
- 425
- Enrollment target
- 20
- Study locations
NCT03732833: Completed Phase 3 study of Lateral Canthal Lines and Glabellar Lines, sponsored by Medy-Tox.
NCT03732833 is a Phase 3 study of Lateral Canthal Lines and Glabellar Lines that has completed, run by Medy-Tox. The registered enrollment target is 425 participants, above the 268-participant average among 5 other Lateral Canthal Lines trials with a reported enrollment target (59% higher). The trial reports 20 study locations across 12 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03732833, a Phase 3 study of Lateral Canthal Lines and Glabellar Lines, has completed, sponsored by Medy-Tox.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 425 participants
- Enrollment target
- 20
- Study locations
Study Summary
To evaluate the safety and efficacy of MT10109L for the treatment of lateral canthal lines (LCL) with or without concurrent treatment of glabellar lines (GL) in participants with moderate to severe LCL and GL.
Primary Outcome
The outcome measured is the percentage of participants who had a ≥2-grade improvement from baseline LCL severity at maximum smile according to investigator and participant FWS ratings at Day 30. Both the INVESTIGATOR AND PARTICIPANT evaluate the LCL severity using a 4-grade scale (0 to 3) where 0=none and 3 = severe. The primary endpoint is achieved and recorded as a count only when BOTH INVESTIGATOR AND PARTICIPANT assess the improvement in FWS from baseline to be ≥ 2-grade improvement. Theref
Conditions Studied
Interventions
- DRUG Placebo
- DRUG MT10109L
Study Locations (20)
Other
- Hautzentrum Koln - Cologne Dermatology - Cologne
- Hautok and Hautok-cosmetics - München
- MediCorium Zentrum fuer Dermatologie und Aesthetik - Oberursel
- CentroDerm GmbH - Wuppertal
New York
- Dermatology and Laser Surgery Center of New York - New York
- Skin Search of Rochester Inc. - Rochester
North Carolina
- M3 Wake Research Inc. - Raleigh
- Wilmington Dermatology Center - Wilmington
Texas
- Westlake Dermatology & Cosmetic Surgery - Westlake - Austin
- DermResearch Inc. - Austin
British Columbia
- Dr. Jean Carruthers Cosmetic Surgery Inc. - Vancouver
- Pacific Derm - Vancouver
Ontario
- Dermetics Cosmetic Dermatology - Burlington
- Nectar Research Group Inc. - Richmond Hill
Arizona
- Clear Dermatology & Aesthetics Center - Scottsdale
California
- Art of Skin MD - Solana Beach
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 425 participants |
| Start Date | 2018-11-05 |
| Est. Completion | 2021-01-25 |
| Phase | Phase 3 |
What the finished NCT03732833 record still lists
NCT03732833 is an interventional study that assigns participants to a tested intervention. The registered 425 participants enrollment target is mid-sized for trials with a published cap, above the 268-participant average among 5 other Lateral Canthal Lines trials with a reported enrollment target (59% higher).
The record links to 2 conditions, with Lateral Canthal Lines appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT03732833 names 20 study sites across 12 states, led by Other, New York, North Carolina.
Frequently Asked Questions
What is clinical trial NCT03732833 about?
NCT03732833 is a clinical study titled "MT10109L in the Treatment of Lateral Canthal Lines With or Without Concurrent Treatment of Glabellar Lines". To evaluate the safety and efficacy of MT10109L for the treatment of lateral canthal lines (LCL) with or without concurrent treatment of glabellar lines (GL) in participants with moderate to severe LCL and GL.
What is the current status of trial NCT03732833?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 425 participants. The study started on 2018-11-05. Estimated completion is 2021-01-25.
What conditions does trial NCT03732833 study?
This clinical trial studies the following conditions: Lateral Canthal Lines, Glabellar Lines.
What interventions are being tested in trial NCT03732833?
The interventions under investigation include: Placebo (DRUG), MT10109L (DRUG).
Who is sponsoring clinical trial NCT03732833?
This trial is sponsored by Medy-Tox, which has 5 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03732833 being conducted?
This trial has 20 study locations across Arizona, California, Florida, Louisiana, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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