MT10109L in the Treatment of Lateral Canthal Lines With or Without Concurrent Treatment of Glabellar Lines
Completed · Phase 3 · Has a placebo group
Conditions studied: Lateral Canthal Lines, Glabellar Lines
In brief
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.
Key facts
- Study ID
- NCT03732833
- Run by
- Medy-Tox
- People needed
- 425
- Starts
- 2018-11-05
- Expected to finish
- 2021-01-25
- Last updated by the study team
- 2023-07-17
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Female participants must not be pregnant or planning to get pregnant and willing to minimize the risk of inducing pregnancy for the duration of the clinical study and follow-up period.
You may not qualify if…
- Known immunization or hypersensitivity to any botulinum toxin serotype.
- Any medical condition that may put the participant at increased risk with exposure to MT10109L including diagnosed myasthenia gravis, Eaton Lambert syndrome, amyotrophic lateral sclerosis, or any other condition that might interfere with neuromuscular function.
- History of facial nerve palsy.
- Any uncontrolled systemic disease.
- Anticipated need for treatment with botulinum toxin of any serotype for any reason during the study (other than study intervention).
- Anticipated need for surgery or overnight hospitalization during the study.
- Prior exposure to botulinum toxin of any serotype for any reason.
- Prior periorbital surgery, facial lift (full face or mid-face), thread lift, brow lift, or related procedures (eg, eyelid [blepharoplasty] and/or eyebrow surgery).
- Prior facial treatment with permanent soft tissue fillers, synthetic implantation (eg, Gore-Tex®), and/or autologous fat transplantation.
- Current enrollment in an investigational drug or device study or participation in such a study within 30 days of entry into this study.
- Females who are pregnant, nursing, or planning a pregnancy during the study.
- Participants who plan for an extended absence away from the immediate area of the study site that would preclude them from returning for all protocol-specified study visits.
Where it is running
- Clear Dermatology & Aesthetics Center — Scottsdale, Arizona, United States
- Art of Skin MD — Solana Beach, California, United States
- Susan H. Weinkle, MD — Bradenton, Florida, United States
- Etre Cosmetic Dermatology and Laser Center — New Orleans, Louisiana, United States
- Dermatology and Laser Surgery Center of New York — New York, New York, United States
- Skin Search of Rochester Inc. — Rochester, New York, United States
- M3 Wake Research Inc. — Raleigh, North Carolina, United States
- Wilmington Dermatology Center — Wilmington, North Carolina, United States
- Aventiv Research Inc. — Dublin, Ohio, United States
- Westlake Dermatology & Cosmetic Surgery - Westlake — Austin, Texas, United States
- DermResearch Inc. — Austin, Texas, United States
- Dr. Jean Carruthers Cosmetic Surgery Inc. — Vancouver, British Columbia, Canada
- Pacific Derm — Vancouver, British Columbia, Canada
- Dermetics Cosmetic Dermatology — Burlington, Ontario, Canada
- Nectar Research Group Inc. — Richmond Hill, Ontario, Canada
- Rosenpark Research — Darmstadt, Hesse, Germany
- Hautzentrum Koln - Cologne Dermatology — Cologne, Germany
- Hautok and Hautok-cosmetics — München, Germany
- MediCorium Zentrum fuer Dermatologie und Aesthetik — Oberursel, Germany
- CentroDerm GmbH — Wuppertal, Germany
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.