NCT02159729

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

Long-term Follow-up Study of Subjects Who Completed Kythera-sponsored Trials of ATX-101 (Sodium Deoxycholate Injection) for the Reduction of Localized Subcutaneous Fat in the Submental Area

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 205 (actual)
• Sponsor: Kythera Biopharmaceuticals · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

This was a long-term follow-up study of participants who completed Kythera-sponsored trials of ATX-101 (06-03, 07-07, 09-15)

Detailed description

No study medication was administered in this study.

Conditions

• Submental Fat
• Healthy

Interventions

Type	Name	Description
DRUG	Placebo	Clinical evaluation, patient reported outcome questionnaires, photographs, caliper measurements and recording adverse events
DRUG	ATX-101 (1 mg/cm^2)	Clinical evaluation, patient reported outcome questionnaires, photographs, caliper measurements and recording adverse events
DRUG	ATX-101 (2 mg/cm^2)	Clinical evaluation, patient reported outcome questionnaires, photographs, caliper measurements and recording adverse events
DRUG	ATX-101 (4 mg/cm^2)	Clinical evaluation, patient reported outcome questionnaires, photographs, caliper measurements and recording adverse events

Timeline

• Start date: 2009-02-01
• Primary completion: 2015-12-01
• Completion: 2015-12-01
• First posted: 2014-06-10
• Last updated: 2020-02-17
• Results posted: 2020-02-17

Locations

20 sites across 4 countries: United States, Australia, Canada, United Kingdom