Trials / Completed
CompletedNCT03682471
Long-term 24-month Follow-up Study on Safety and Maintenance of Efficacy of ATX-101 (Sodium Deoxycholate Injection)
Long-term, Follow-up Study of Subjects Who Completed Phase III Trials ATX-101-10-16 or ATX-101-10-17 (Sodium Deoxycholate Injection) for the Reduction of Localized Subcutaneous Fat in the Submental Area
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 201 (actual)
- Sponsor
- Allergan · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| 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. |
Timeline
- Start date
- 2012-02-14
- Primary completion
- 2013-12-13
- Completion
- 2013-12-13
- First posted
- 2018-09-24
- Last updated
- 2018-09-24
Locations
18 sites across 1 country: Germany
Source: ClinicalTrials.gov record NCT03682471. Inclusion in this directory is not an endorsement.