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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
84
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.
Investigational Site
Tempe, Arizona, United States
Change From Baseline in Pain Visual Analog Scale Scores
Participants were provided with a scale 100 mm in length and were asked to mark the place on the line that best represents his or her pain associated with the area treated with study drug. The scale ranged from 0 (no pain) to 100 (most severe pain possible).
Time frame: Baseline and Day 84
Change From Baseline in Pain Assessment Using McGill Pain Questionnaire
Participants rated 15 pain characteristics by using a number to signify how much of that specific type of pain they were experiencing using the Short-Form McGill Pain Questionnaire. The pain characteristic options included Throbbing, Shooting, Stabbing, Sharp, Cramping, Gnawing, Hot-burning, Aching, Heavy, Tender, Splitting, Tiring-exhausting, Sickening, Fearful, and Punishing- cruel. Participants assessed the intensity of each characteristic using the following score system: none (0), mild (1), moderate (2), and severe (3). In addition, present pain was assessed on a scale from 0 (no pain) to 5 (excruciating).
Time frame: Baseline (predose) and Day 84
Swelling Grading Scale Scores
The following grading system was used for the assessment of swelling: * Swelling/edema absent (0) * Minimal swelling/edema contained within treatment area (1) * Modest swelling/edema contained within treatment area (2) * Substantial swelling/edema contained within treatment area (3) * Swelling/edema of the neck and face beyond the treatment area (4)
Time frame: Day 84
Bruising Grading Scale Scores
The following grading system was used for the assessment of bruising: * Bruising absent (0) * Bruising associated with 1 to 3 needle insertion points (1) * Bruising spreading beyond 4 or more individual needle insertion points but contained within the treatment area (2) * Bruising covering the entire treatment area but contained within the treatment area (3) * Bruising of the neck and face beyond the treatment area (4)
Time frame: Day 84
Induration Grading Scale Scores
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
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.
The following grading system was used for the assessment of induration: * Induration absent to minimal (0) * Induration associated with at least approximately 30% of the treatment area (1) * Induration associated with greater than approximately 30% to at least 60% of the treatment area (2) * Induration covering the entire treatment area but contained within the treatment area (3) * Induration of the neck and face beyond the treatment area (4)
Time frame: Day 84
Change From Baseline in Clinician-Reported Submental Fat Rating Scale (CR-SMFRS)
The CR-SMFRS score is based on the investigator's clinical evaluation of the participant, where submental fullness is scored on a 5-point ordinal scale (0-4) with 0 = absent, 1 = mild, 2 = moderate, 3 = severe, and 4 = extreme. A negative change from Baseline indicates improvement.
Time frame: Baseline and Day 84
Change From Baseline in Patient-Reported Submental Fat Rating Scale (PR-SMFRS)
The PR-SMFRS is based on the participant's response to the question "How much fat do you have under your chin right now?" answered on a 5-point ordinal scale (0-4) with 0 = no chin fat at all, 1 = a slight amount of chin fat, 2 = a moderate amount of chin fat, 3 = a large amount of chin fat, and 4 = a very large amount of chin fat. A negative change from Baseline indicates improvement.
Time frame: Baseline and Day 84
Change From Baseline in Subject Self Rating Scale (SSRS)
The SSRS assesses participant's satisfaction with their appearance in association with the face and chin on a 7-point scale from 0 to 6: where 0 = Extremely dissatisfied, 1 = Dissatisfied, 2 = Slightly dissatisfied, 3 = Neither satisfied nor dissatisfied, 4 = Slightly satisfied, 5 = Satisfied and 6 = Extremely satisfied. A positive change from Baseline indicates improvement.
Time frame: Baseline and Day 84
Change From Baseline in Submental Skin Laxity Grades (SMSLG)
Skin laxity assessment was based on clinical evaluation and palpation of the submental area on the following scale: 1 = no laxity; 2 = mild laxity; 3 = moderate laxity; 4 = severe laxity. A negative change from Baseline indicates improvement.
Time frame: Baseline and Day 84
Change From Baseline in Submental Fat Thickness
Submental thickness was measured using caliper devices.
Time frame: Baseline and Day 84
Patient Experience Questions
Participants were asked to complete 3 patient experience questions, each answered as Yes or No: Given your experience in this study: 1. Would you recommend this procedure to a friend? 2. Would you agree to receive additional treatments? 3. Has the treatment you received in this study affected your normal activities? The percentage of participants answering Yes on each question is reported.
Time frame: Day 84