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NCT02163902 · ClinicalTrials.gov registry record · Phase 3
Long-term Follow-up Study on Safety and Maintenance of Efficacy of ATX-101
A Phase 3 study of Healthy and Submental Fat, sponsored by Kythera Biopharmaceuticals.
- Completed
- Registry status
- Phase 3
- Development phase
- 224
- Enrollment target
- 15
- Study locations
NCT02163902: Completed Phase 3 study of Healthy and Submental Fat, sponsored by Kythera Biopharmaceuticals.
NCT02163902 is a Phase 3 study of Healthy and Submental Fat that has completed, run by Kythera Biopharmaceuticals. The registered enrollment target is 224 participants, below the 647-participant average among 1,090 other Healthy trials with a reported enrollment target (65% lower). The trial reports 15 study locations across 8 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02163902, a Phase 3 study of Healthy and Submental Fat, has completed, sponsored by Kythera Biopharmaceuticals.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 224 participants
- Enrollment target
- 15
- Study locations
Study Summary
The investigation of the long-term safety and maintenance of efficacy of ATX-101 in reduction of submental fat.
Primary Outcome
The investigator evaluated the participant's chin and neck area using the Clinician-Reported Submental Fat Rating Scale (a 5-point scale) where: 0=absent submental convexity (best) to 4= extreme submental convexity (worst). Non-responders at LTFU baseline in each treatment group (including placebo) were not included in the analysis.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG ATX-101
Study Locations (15)
Florida
- Dermatology Research Institute - Coral Gables
- Stephan Baker MD PA - Coral Gables
- Baumann Cosmetic and Research Center - Miami
- Kenneth R. Beer, MD, PA - West Palm Beach
Illinois
- Altman Dermatology Associates - Arlington Hts
- DeNova Research - Chicago
- DuPage Medical Group, Dermatology Institute - Naperville
Maryland
- Callender Center for Clinical Research - Glendale
- Aesthetics, Skin Care, Dermatologic Surgery - Rockville
Other
- Shannon Humphrey, MD - Vancouver
- Carruthers Dermatology Centre Inc. - Vancouver
California
- Dermatology Cosmetic Laser Medical Associates of La Jolla - San Diego
Colorado
- AboutSkin Dermatology and DermSurgery, PC - Englewood
Tennessee
- Tennessee Clinical Research Center - Nashville
Texas
- Research Across America - Plano
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 224 participants |
| Start Date | 2013-12 |
| Est. Completion | 2016-08 |
| Phase | Phase 3 |
What the finished NCT02163902 record still lists
NCT02163902 is an interventional study that assigns participants to a tested intervention. The registered 224 participants enrollment target is mid-sized for trials with a published cap, below the 647-participant average among 1,090 other Healthy trials with a reported enrollment target (65% lower).
The record links to 2 conditions, with Healthy appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT02163902 lists 15 locations in 8 states (Florida, Illinois, Maryland).
Frequently Asked Questions
What is clinical trial NCT02163902 about?
NCT02163902 is a clinical study titled "Long-term Follow-up Study on Safety and Maintenance of Efficacy of ATX-101". The investigation of the long-term safety and maintenance of efficacy of ATX-101 in reduction of submental fat.
What is the current status of trial NCT02163902?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 224 participants. The study started on 2013-12. Estimated completion is 2016-08.
What conditions does trial NCT02163902 study?
This clinical trial studies the following conditions: Healthy, Submental Fat.
What interventions are being tested in trial NCT02163902?
The interventions under investigation include: Placebo (DRUG), ATX-101 (DRUG).
Who is sponsoring clinical trial NCT02163902?
This trial is sponsored by Kythera Biopharmaceuticals, which has 19 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02163902 being conducted?
This trial has 15 study locations across California, Colorado, Florida, Illinois, Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Healthy
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT02163902's enrollment target sits among peer trials
224 111th of 1090 higher than 979 of 1,090 other Healthy trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Healthy trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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