MT10109L in the Long-term, Open-label Treatment of Glabellar Lines (GL) and Lateral Canthal Lines (LCL)

Completed · Phase 3 · Has a placebo group

Conditions studied: Glabellar Lines, Lateral Canthal Lines

In brief

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.

Key facts

Study ID

NCT04157686

Run by

Medy-Tox

People needed

957

Starts

2019-10-23

Expected to finish

2023-02-16

Last updated by the study team

2024-08-09

Who can join

Age: 19 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Completion of lead-in Phase 3 study;
• 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;
• Known allergy or sensitivity to any of the components of the study interventions, or any materials used in the study procedures;
• 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
• The Eye Research Foundation — Newport Beach, California, United States
• Art of Skin MD — Solana Beach, California, United States
• Susan H. Weinkle — Bradenton, Florida, United States
• Skin Research Institute — Coral Gables, Florida, United States
• Coleman Center For Cosmetic Dermatologic Surgery — Metairie, Louisiana, United States
• Etre Cosmetic Dermatology and Laser Center — New Orleans, Louisiana, United States
• MD Laser Skin & Vein — Hunt Valley, Maryland, United States
• Laser & Skin 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 Dublin — Dublin, Ohio, United States
• Westlake Dermatology & Cosmetic Surgery - Westlake — Austin, Texas, United States
• DermResearch Inc. — Austin, Texas, United States
• Bellaire Dermatology — Bellaire, Texas, United States
• SkinDC — Arlington, Virginia, United States
• Virginia Clinical Research, Inc. — Norfolk, Virginia, United States
• UZ Brussel — Jette, Brussels Capital, Belgium
• Medical Skincare — Sint-Truiden, Limburg, Belgium
• Dr. Shannon Humphrey Inc. — Vancouver, British Columbia, Canada
• Project Skin MD LTD — Vancouver, British Columbia, Canada
• Pacific Derm — Vancouver, British Columbia, Canada
• Dermetics Cosmetic Dermatology — Burlington, Ontario, Canada
• The Center For Dermatology — Richmond Hill, Ontario, Canada

Full record on ClinicalTrials.gov

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