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Long-term 24-month Follow-up Study on Safety and Maintenance of Efficacy of ATX-101 (Sodium Deoxycholate Injection)

NCT03682471 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 201

Last updated 2018-09-24

No results posted yet for this study

Summary

The objective of this non-treatment, placebo-controlled, observational, 24-month follow-up study was to evaluate the long-term efficacy and safety of subcutaneous (SC) injections of deoxycholic acid (ATX-101) in the submental area. No treatment was administered in this study. Participants who previously received deoxycholic acid injections in studies ATX-101-10-16 \[NCT01305577\] or ATX-101-10-17 \[NCT01294644\] were enrolled in this non-treatment observational follow-up study to further evaluate safety and efficacy.

Conditions

  • Subcutaneous Fat

Interventions

DRUG

Deoxycholic acid Injection

Solution for subcutaneous injection.

DRUG

Placebo

Placebo, 10 mM sodium phosphate, 0.9% \[w/v\] sodium chloride in water for subcutaneous injection.

Sponsors & Collaborators

  • Allergan

    lead INDUSTRY

Principal Investigators

  • Beta Bowen · Allergan

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-02-14
Primary Completion
2013-12-13
Completion
2013-12-13

Countries

  • Germany

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03682471 on ClinicalTrials.gov