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NCT04157686 · ClinicalTrials.gov registry record · Phase 3
MT10109L in the Long-term, Open-label Treatment of Glabellar Lines (GL) and Lateral Canthal Lines (LCL)
A Phase 3 study of Lateral Canthal Lines and Glabellar Lines, sponsored by Medy-Tox.
- Completed
- Registry status
- Phase 3
- Development phase
- 957
- Enrollment target
- 20
- Study locations
NCT04157686: Completed Phase 3 study of Lateral Canthal Lines and Glabellar Lines, sponsored by Medy-Tox.
NCT04157686 is a Phase 3 study of Lateral Canthal Lines and Glabellar Lines that has completed, run by Medy-Tox. The registered enrollment target is 957 participants, above the 162-participant average among 5 other Lateral Canthal Lines trials with a reported enrollment target (491% higher). The trial reports 20 study locations across 12 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04157686, a Phase 3 study of Lateral Canthal Lines and Glabellar Lines, has completed, sponsored by Medy-Tox.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 957 participants
- Enrollment target
- 20
- Study locations
Study Summary
To evaluate the long-term safety of MT10109L in the treatment of GL and/or LCL in participants with moderate to severe GL and/or LCL.
Primary Outcome
The safety analyses were conducted in the Intent-to-Treat (ITT) population. All adverse events were collected from the signing of the ICF to 30 days after the participant's last study visit.
Conditions Studied
Interventions
- DRUG MT10109L Dose 1
- DRUG MT10109L Dose 2
- DRUG MT10109L Dose 1 + Dose 2
Study Locations (20)
Texas
- Westlake Dermatology & Cosmetic Surgery - Westlake - Austin
- DermResearch Inc. - Austin
- Bellaire Dermatology - Bellaire
California
- The Eye Research Foundation - Newport Beach
- Art of Skin MD - Solana Beach
Florida
- Susan H. Weinkle - Bradenton
- Skin Research Institute - Coral Gables
Louisiana
- Coleman Center For Cosmetic Dermatologic Surgery - Metairie
- Etre Cosmetic Dermatology and Laser Center - New Orleans
New York
- Laser & Skin Surgery Center of New York - New York
- Skin Search of Rochester Inc. - Rochester
North Carolina
- M3 Wake Research Inc. - Raleigh
- Wilmington Dermatology Center - Wilmington
Virginia
- SkinDC - Arlington
- Virginia Clinical Research, Inc. - Norfolk
Arizona
- Clear Dermatology & Aesthetics Center - Scottsdale
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 957 participants |
| Start Date | 2019-10-23 |
| Est. Completion | 2023-02-16 |
| Phase | Phase 3 |
What the finished NCT04157686 record still lists
NCT04157686 is an interventional study that assigns participants to a tested intervention. The registered 957 participants enrollment target is mid-sized for trials with a published cap, above the 162-participant average among 5 other Lateral Canthal Lines trials with a reported enrollment target (491% higher).
The record links to 2 conditions, with Lateral Canthal Lines appearing as the primary indexed condition, and to 3 interventions - of which MT10109L Dose 1 is the first listed.
NCT04157686 names 20 study sites across 12 states, led by Texas, California, Florida.
Frequently Asked Questions
What is clinical trial NCT04157686 about?
NCT04157686 is a clinical study titled "MT10109L in the Long-term, Open-label Treatment of Glabellar Lines (GL) and Lateral Canthal Lines (LCL)". To evaluate the long-term safety of MT10109L in the treatment of GL and/or LCL in participants with moderate to severe GL and/or LCL.
What is the current status of trial NCT04157686?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 957 participants. The study started on 2019-10-23. Estimated completion is 2023-02-16.
What conditions does trial NCT04157686 study?
This clinical trial studies the following conditions: Lateral Canthal Lines, Glabellar Lines.
What interventions are being tested in trial NCT04157686?
The interventions under investigation include: MT10109L Dose 1 (DRUG), MT10109L Dose 2 (DRUG), MT10109L Dose 1 + Dose 2 (DRUG).
Who is sponsoring clinical trial NCT04157686?
This trial is sponsored by Medy-Tox, which has 5 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04157686 being conducted?
This trial has 20 study locations across Arizona, California, Florida, Louisiana, Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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