Patient Experience Study of Deoxycholic Acid Injection
Condition: Moderate or Severe Submental Fullness
Intervention: Deoxycholic Acid Injection; Placebo; Cold Compress; Lidocaine / Epinephrine; Loratadine; Ibuprofen; Compression Chin Strap
Intervention description: Formulated as an injectable solution containing deoxycholic acid at a concentration of 10 mg/mL.; Phosphate buffered saline placebo for injection; A cold compress was applied to the injection area for 10 minutes before dosing and for 15 minutes after dosing.; Lidocaine 4% topical cream applied 45 minutes prior to dosing across the area to be treated, followed by 0.4 mL SC injections of lidocaine HCl 1% / epinephrine 1:100,000 around the perimeter of the treatment area and across the treatment area in a regular pattern 25 minutes before dosing.; Loratadine 10 mg orally from Day -7 until Day 7; Ibuprofen 600 mg at least 1 hour prior to dosing and 600 mg 3 times a day for at least 3 days after dosing.; A compression chin strap was applied 15 minutes after dosing for at least 24 hours.
Intervention MeSH terms: Loratadine; Ibuprofen; Lidocaine; Epinephrine; Deoxycholic Acid
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 84.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      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.
    

Eligibility criteria:

        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.