Open-Label Study of Deoxycholic Acid for the Reduction of Localized Subcutaneous Fat in the Submental Area
Condition: Moderate or Severe Submental Fullness
Intervention: Deoxycholic acid injection
Intervention description: Formulated as an injectable solution containing deoxycholic acid at a concentration of 10 mg/mL.
Intervention MeSH terms: Deoxycholic Acid
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 165.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      To evaluate the safety of deoxycholic acid subcutaneous injections in the submental area
      (below the chin).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Submental fat graded by the investigator as 2, 3, or 4 using the Clinician-Reported
             Submental Fat Rating Scale (CR-SMFRS) and graded by the subject as 2, 3, or 4 using
             the Patient-Reported Submental Fat Rating Scale (PR-SMFRS) as determined on visit 1
             (within 28 days before the subject's first dosing session)

          -  Dissatisfaction with the submental area rated by the subject as 0, 1, or 2 using the
             Subject Self-rating Scale (SSRS) as determined on visit 1 (within 28 days before the
             subject's first dosing session)

          -  Males and nonpregnant, nonlactating females 18 years of age or greater, on the day of
             the subject's first dosing session (visit 2). Females of childbearing potential must
             have a negative human chorionic gonadotropin (serum) test result within 28 days before
             visit 2 and agree to practice adequate contraception, in the judgment of the
             investigator, during the course of the study

          -  A normal result on coagulation tests (prothrombin time (PT), partial thromboplastin
             time (PTT)) obtained within 28 days before subject's first dosing session

          -  History of stable body weight, in the judgment of the investigator, for at least 6
             months before subject's first dosing session

          -  Expected to understand and comply with the visit schedule and all protocol-specified
             tests and procedures and agreement by the subject to refrain from making significant
             changes, in the judgment of the investigator, to his or her dietary or exercise habits
             during the course of the subject's participation

          -  Medically able to undergo the administration of study drug determined by clinical and
             laboratory tests obtained within 28 days before subject's first dosing session for
             which the investigator identifies no clinically significant abnormality

          -  Signed informed consent obtained before any study-specific procedure is performed

        Exclusion Criteria:

          -  History of any intervention to treat submental fat (eg, liposuction, surgery, or
             lipolytic agents)

          -  History of trauma associated with the chin or neck areas, which in the judgment of the
             investigator may affect evaluation of safety or efficacy of treatment

          -  A grade of 4 on the Submental Skin Laxity Grading scale (SMSLG) or any other
             anatomical feature (eg, predominant subplatysmal fat, loose skin in the neck or chin
             area, prominent platysmal bands) for which reduction in submental fat may, in the
             judgment of the investigator, result in an aesthetically unacceptable outcome

          -  Evidence of any cause of enlargement in the submental area (eg, thyroid enlargement,
             cervical adenopathy) other than localized submental fat

          -  Body mass index of ≥ 40 kg/m² as determined on visit 1 (week 0)

          -  History or current symptoms of dysphagia

          -  Any medical condition that would interfere with assessment of safety or efficacy or
             compromise the subject's ability to undergo study procedures or give informed consent

          -  Treatment with radio frequency, laser procedures, chemical peels, or dermal fillers in
             the neck or chin area within 12 months before the first treatment session, or
             botulinum toxin injections in the neck or chin area within 6 months before the first
             treatment session

          -  History of sensitivity to any components of the study drug or to topical or local
             anesthetics (eg, lidocaine, benzocaine, novocaine)

          -  Previous treatment in this study or previous participation in a Kythera-sponsored
             ATX-101 study

          -  Treatment with an investigational device or agent within 30 days before the subject's
             first treatment session