Patient Experience Study of Deoxycholic Acid Injection

A Single Center, Double-blind, Parallel-group, Two Factor Patient-Experience Management Study of ATX-101 (Deoxycholic Acid Injection) for the Reduction of Localized Subcutaneous Fat in the Submental Area

The objectives of this study are to determine the safety of deoxycholic acid subcutaneous (SC) injections in the submental area and to evaluate the effects of four interventions, relative to placebo in the submental area, particularly with regard to assessment and management of pain, bruising, and swelling/edema.

This study evaluated the effects of four interventions, pre- and post-subcutaneous injections of deoxycholic acid injection relative to placebo in adults with submental fullness. Participants were randomized to either deoxycholic acid injection or placebo in a ratio of 4:1 and to one of four patient experience management paradigms.

Participants were required to visit the research facility on 10 separate occasions for protocol-defined treatments, procedures, tests, and observations.

Inclusion Criteria:

1. Submental fat graded by the Investigator as 2 (moderate) or 3 (severe) using the Clinician-Reported Submental Fat Rating Scale (CR-SMFRS) and graded by the subject as 2 (moderate amount) or 3 (large amount) using the Patient-Reported Submental Fat Rating Scale (PR-SMFRS)
2. Dissatisfaction with the appearance of the submental area expressed by the subject as a rating of 0, 1, or 2 using the Subject Self Rating Scale (SSRS)
3. History of stable body weight for at least 6 months and body mass index (BMI) of ≤ 40 kg/m².
4. Acceptable skin laxity as determined by the investigator
5. Agreement by the subject to refrain from making significant changes, in the documented judgment of the investigator, to his or her dietary or exercise habits during the course of the subject's participation.
6. Agreement to forego any treatment or behavior (e.g., unshaven facial hair)
7. Signed informed consent obtained before any study-specific procedure is performed.

Exclusion Criteria:

1. No prior intervention for submental fullness or recent cosmetic procedure in the neck or chin area
2. Absence of clinically significant health problems
3. Body mass index > 40.0 kg/m² as determined prior to randomization.
4. History of drug or alcohol abuse.