Clinical trial NCT01294644: Evaluation of Safety and Efficacy of Deoxycholic Acid Injection (ATX-101) in the Reduction of Submental Fat
Official title: Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Study of ATX-101 (Sodium Deoxycholate Injection) Versus Placebo 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
Collaborators: name: Bayer
First posted: 2011-02-11
Enrollment: 360
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To evaluate the safety and efficacy of deoxycholic acid injection in the reduction of submental fat (fat below the chin).


Eligibility criteria: Inclusion Criteria:

1. Submental fat graded by the investigator as 2 or 3 using the Clinician-Reported Submental Fat Rating Scale (CR-SMFRS) as determined on Visit 2.
2. Dissatisfaction with the submental area rated by the subject as 0, 1, 2, or 3 using the Subject Self Rating Scale (SSRS).
3. Males and nonpregnant, nonlactating females between 18 and 65 years of age, inclusive on the day of randomization. Females of childbearing potential must have a negative human chorionic gonadotropin (hCG) test result within 28 days before randomization and agree to practice medically acceptable birth control during the course of the study. Medically acceptable birth control includes: surgical sterilization, hormonal contraceptives, barrier methods or an intrauterine device (IUD).
4. History of stable body weight, in the judgment of the investigator, for at least 6 months before randomization. No significant change, in the judgment of the investigator, in diet or exercise practices for at least 6 months before randomization and agreement to not change diet or exercise practices during the course of the study.
5. Expected to comply with and understand the visit schedule and all protocol-specified tests and procedures.
6. Medically able to undergo the administration of study material determined by clinical evaluations made within 56 days before and laboratory tests obtained within 28 days before randomization for which the investigator identified no clinically significant abnormality.
7. Signed informed consent obtained before any study-specific procedure is performed.

Exclusion Criteria:

1. History of any intervention to treat submental fat (e.g., liposuction, surgery, or lipolytic agents) or trauma associated with the chin or neck areas, which in the judgment of the investigator may affect evaluation of safety or efficacy of treatment.
2. Loose skin in the neck or chin area for which reduction in submental fat may, in the judgment of the investigator, result in an aesthetically unacceptable outcome or a score of 4 on the Skin Laxity Rating Scale (SLRS).
3. Prominent platysmal bands at rest or other anatomical features that, in the judgment of the investigator, may interfere with the evaluation of submental fat or result in an aesthetically unacceptable outcome.
4. Evidence of any cause of enlargement in the submental area (e.g., thyroid enlargement or cervical adenopathy) other than localized submental fat.
5. Body mass index (BMI) greater than 30.
6. Currently on or considering starting a weight reduction regimen.
7. Any medical condition (e.g., respiratory, cardiovascular, hepatic, neurological disease, uncontrolled hypertension, or thyroid dysfunction) that would interfere with assessment of safety or efficacy or compromise the subject's ability to undergo study procedures or provide informed consent.
8. Treatment with radio frequency, laser procedures, chemical peels, or dermal fillers in the neck or chin area within 12 months before randomization, or botulinum toxin injections in the neck or chin area within 6 months before randomization.
9. History of sensitivity to any components of the study material or to topical or local anesthetics (e.g., lidocaine, benzocaine, or novocaine).
10. Previous randomization into this study or previous treatment with ATX-101.
11. Treatment with an investigational device or agent within 30 days of randomization.

Primary outcomes:
measure: Percentage of Participants With a Clinician-Reported Submental Fat Rating Scale (CR-SMFRS) 1-grade Response
timeFrame: Baseline and 12 weeks after last treatment (up to 24 weeks after first dose)
measure: Percentage of Participants With a Subject Self Rating Scale (SSRS) Response
timeFrame: Baseline and 12 weeks after last treatment (up to 24 weeks after first dose)
Secondary outcomes:
measure: Percentage of Participants With a CR-SMFRS 2-grade Response
timeFrame: Baseline and 12 weeks after last treatment (up to 24 weeks after first dose)
measure: Change From Baseline in CR-SMFRS Score
timeFrame: Baseline and 12 weeks after last treatment (up to 24 weeks after first dose)
measure: Change From Baseline in SSRS Scores
timeFrame: Baseline and 12 weeks after last treatment (up to 24 weeks after first dose)
measure: Change From Baseline in Submental Fat Thickness
timeFrame: Baseline and 12 weeks after last treatment (up to 24 weeks after first dose)
measure: Change From Baseline in Patient-reported Submental Fat Rating Scale (PR-SMFRS)
timeFrame: Baseline and 12 weeks after last treatment (up to 24 weeks after first dose)
measure: Change From Baseline in Patient-Reported Submental Fat Impact Scale (PR-SMFIS)
timeFrame: Baseline and 12 weeks after last treatment (up to 24 weeks after first dose)
measure: Change From Baseline in Self-rating of Attractiveness
timeFrame: Baseline and 12 weeks after last treatment (up to 24 weeks after first dose)
measure: Change From Baseline in Derriford Appearance Scale 24 (DAS24)
timeFrame: Baseline and 12 weeks after last treatment (up to 24 weeks after first dose)
measure: Change From Baseline in Body Image Quality of Life Inventory (BIQLI)
timeFrame: Baseline and 12 weeks after last treatment (up to 24 weeks after first dose)
Other outcomes:
Locations:
city: Geel
country: Belgium
facility: Investigational Site
city: Genk
country: Belgium
facility: Investigational Site
city: Besançon
country: France
facility: Investigational Site
city: Nice
country: France
facility: Investigational Site
city: Paris
country: France
facility: Investigational Site
city: Paris
country: France
facility: Investigational Site
city: Rouen
country: France
facility: Investigational Site
city: Recklinghausen
country: Germany
facility: Investigational Site
state: Nordrhein-Westfalen
city: Berlin
country: Germany
facility: Investigational Site
city: Berlin
country: Germany
facility: Investigational Site
city: Bochum
country: Germany
facility: Investigational Site
city: Dresden
country: Germany
facility: Investigational Site
city: Dresden
country: Germany
facility: Investigational Site
city: Erlangen
country: Germany
facility: Investigational Site
city: Freiburg
country: Germany
facility: Investigational Site
city: Hamburg
country: Germany
facility: Investigational Site
city: Hamburg
country: Germany
facility: Investigational Site
city: Kassel
country: Germany
facility: Investigational Site
city: Lübeck
country: Germany
facility: Investigational Site
city: Mahlow
country: Germany
facility: Investigational Site
city: Monchengladbach
country: Germany
facility: Investigational Site
city: Münster
country: Germany
facility: Investigational Site
city: Regensburg
country: Germany
facility: Investigational Site
city: Roma
country: Italy
facility: Investigational Site
city: Madrid
country: Spain
facility: Investigational Site
city: Birmingham
country: United Kingdom
facility: Investigational Site
city: Cardiff
country: United Kingdom
facility: Investigational Site
city: London
country: United Kingdom
facility: Investigational Site
city: Loughborough
country: United Kingdom
facility: Investigational Site
Study officials:
affiliation: Kythera Biopharmaceuticals, Inc.
name: Frederick Beddingfield, MD, PhD
role: STUDY_DIRECTOR
References: