drugset / Trial / NCT03241563

Subcutaneous Sodium Deoxycholate Injections With or Without Triamcinolone for Reduction of Submental Fat

NCT03241563

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

EvaluationDrugModalityDoseRoute
Comparator ATX-101 Peptide 100 mg Subcutaneous
Comparator Triamcinolone Other / unclassified 40 mg/ml Subcutaneous

Indications

No indication recorded.