Clinical trial NCT02007434: Patient Experience Study of Deoxycholic Acid Injection
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Moderate or Severe Submental Fullness
Lead sponsor: Kythera Biopharmaceuticals
Sponsor class: INDUSTRY
First posted: 2013-12-10
Enrollment: 84
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed description: 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.

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.

Primary outcomes:
measure: Change From Baseline in Pain Visual Analog Scale Scores
timeFrame: Baseline and Day 84
measure: Change From Baseline in Pain Assessment Using McGill Pain Questionnaire
timeFrame: Baseline (predose) and Day 84
measure: Swelling Grading Scale Scores
timeFrame: Day 84
measure: Bruising Grading Scale Scores
timeFrame: Day 84
measure: Induration Grading Scale Scores
timeFrame: Day 84
Secondary outcomes:
measure: Change From Baseline in Clinician-Reported Submental Fat Rating Scale (CR-SMFRS)
timeFrame: Baseline and Day 84
measure: Change From Baseline in Patient-Reported Submental Fat Rating Scale (PR-SMFRS)
timeFrame: Baseline and Day 84
measure: Change From Baseline in Subject Self Rating Scale (SSRS)
timeFrame: Baseline and Day 84
measure: Change From Baseline in Submental Skin Laxity Grades (SMSLG)
timeFrame: Baseline and Day 84
measure: Change From Baseline in Submental Fat Thickness
timeFrame: Baseline and Day 84
measure: Patient Experience Questions
timeFrame: Day 84
Other outcomes:
Locations:
city: Tempe
country: United States
facility: Investigational Site
state: Arizona
Study officials:
affiliation: Sponsor GmbH
name: Frederick Beddingfield, III, MD, PhD
role: STUDY_DIRECTOR
References:
citation: Dover JS, Kenkel JM, Carruthers A, Lizzul PF, Gross TM, Subramanian M, Beddingfield FC 3rd. Management of Patient Experience With ATX-101 (Deoxycholic Acid Injection) for Reduction of Submental Fat. Dermatol Surg. 2016 Nov;42 Suppl 1:S288-S299. doi: 10.1097/DSS.0000000000000908.