Long-term Follow-up Study on Safety and Maintenance of Efficacy of ATX-101

Completed · Phase 3 · Has a placebo group

Conditions studied: Submental Fat, Healthy

In brief

The investigation of the long-term safety and maintenance of efficacy of ATX-101 in reduction of submental fat.

Key facts

Study ID

NCT02163902

Run by

Kythera Biopharmaceuticals

People needed

224

Starts

2013-12-01

Expected to finish

2016-08-01

Last updated by the study team

2020-02-17

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Any participant who completed follow-up visits at 12 and 24 weeks after the last dose in one of the two predecessor studies
• Willingness to comply with the schedule and procedures of this study.
• Signed informed consent form (ICF).

You may not qualify if…

• Participants who have had any treatment or condition (e.g., pregnancy or metabolic disease, which may lead to unstable weight) that may affect assessment of safety or efficacy since enrollment in the predecessor study.

Where it is running

• Dermatology Cosmetic Laser Medical Associates of La Jolla — San Diego, California, United States
• AboutSkin Dermatology and DermSurgery, PC — Englewood, Colorado, United States
• Dermatology Research Institute — Coral Gables, Florida, United States
• Stephan Baker MD PA — Coral Gables, Florida, United States
• Baumann Cosmetic and Research Center — Miami, Florida, United States
• Kenneth R. Beer, MD, PA — West Palm Beach, Florida, United States
• Altman Dermatology Associates — Arlington Hts, Illinois, United States
• DeNova Research — Chicago, Illinois, United States
• DuPage Medical Group, Dermatology Institute — Naperville, Illinois, United States
• Callender Center for Clinical Research — Glendale, Maryland, United States
• Aesthetics, Skin Care, Dermatologic Surgery — Rockville, Maryland, United States
• Tennessee Clinical Research Center — Nashville, Tennessee, United States
• Research Across America — Plano, Texas, United States
• Shannon Humphrey, MD — Vancouver, Canada
• Carruthers Dermatology Centre Inc. — Vancouver, Canada

Full record on ClinicalTrials.gov

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