drugset / Trial / NCT03241563
Subcutaneous Sodium Deoxycholate Injections With or Without Triamcinolone for Reduction of Submental Fat
RandomizedParallel-groupDouble-blindTreatment
Summary
The subjects and evaluating investigator will be blinded to the treatment, thus maintaining double-blind status. By nature of the varying volumes of injection, the treating investigator will be unblinded to the treatment. A series of 3 injection sessions will be performed spaced 4 weeks apart. Canfield Vectra 3D imaging will be performed at baseline and at each follow up visit. Follow up visits will be performed 3 and 5 days after each injection session to assess for side effect and tolerability profile. After the final injection session, additional follow up visits will be performed at days 90 and 180 to assess for efficacy. Subject weight will be recorded at baseline and at end of study.
Timeline
- Start
- 2016-04
- Primary completion
- 2017-02
- Completion
- 2017-02
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | ATX-101 | Peptide | 100 mg | Subcutaneous |
| Comparator | Triamcinolone | Other / unclassified | 40 mg/ml | Subcutaneous |
Indications
No indication recorded.