MT10109L in the Treatment of Glabellar Lines (GL) With or Without Concurrent Treatment of Lateral Canthal Lines (LCL)
Completed · Phase 3 · Has a placebo group
Conditions studied: Glabellar Lines, Lateral Canthal Lines
In brief
To evaluate the safety and efficacy of MT10109L for the treatment of glabellar lines (GL) with or without concurrent treatment of lateral canthal lines (LCL) in participants with moderate to severe GL and LCL.
Key facts
- Study ID
- NCT03721016
- Run by
- Medy-Tox
- People needed
- 415
- Starts
- 2018-10-26
- Expected to finish
- 2021-01-22
- Last updated by the study team
- 2023-05-25
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
- Advanced Research Associates — Glendale, Arizona, United States
- Eye Research Foundation — Newport Beach, California, United States
- Skin Research Institute LLC — Coral Gables, Florida, United States
- Coleman Center for Cosmetic Dermatologic Surgery — Metairie, Louisiana, United States
- MD Laser, Skin, & Vein Institute — Hunt Valley, Maryland, United States
- Laser & Skin Surgery Center of New York — New York, New York, United States
- Bellaire Dermatology Associates — Bellaire, Texas, United States
- SkinDC — Arlington, Virginia, United States
- Virginia Clinical Research, Inc. — Norfolk, Virginia, United States
- Dr. Shannon Humphrey Inc. — Vancouver, British Columbia, Canada
- Project Skin MD — Vancouver, British Columbia, Canada
- Sweat Clinics of Canada — Toronto, Ontario, Canada
- Bertucci MedSpa Inc. — Woodbridge, Ontario, Canada
- Studienzentrum Theatiner46 — Munich, Bavaria, Germany
- DRK-Kliniken Nordhessen — Kassel, Hesse, Germany
- Privatpraxis Dr. Hilton & Partner — Düsseldorf, North Rhine-Westphalia, Germany
- RZANY & HUND - Privatpraxis fur Dermatologie und Asthetische Medizin — Berlin, Germany
- Saleh Aesthetic Clinic Ltd. — Cheadle, England, United Kingdom
- Cranley Clinic — London, England, United Kingdom
- Bermuda Practice — Basingstoke, Hampshire, United Kingdom
- Meyer Clinic — Chichester, West Sussex, United Kingdom
Full record on ClinicalTrials.gov
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