Evaluation of Safety and Efficacy of Deoxycholic Acid Injection (ATX-101) in the Reduction of Submental Fat

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

Sponsors

Lead Sponsor: Kythera Biopharmaceuticals

Collaborator: Bayer

Source Kythera Biopharmaceuticals
Brief Summary

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

Overall Status Completed
Start Date 2011-01-01
Completion Date 2012-02-01
Primary Completion Date 2012-02-01
Phase Phase 3
Study Type Interventional
Primary Outcome
Measure Time Frame
Percentage of Participants With a Clinician-Reported Submental Fat Rating Scale (CR-SMFRS) 1-grade Response Baseline and 12 weeks after last treatment (up to 24 weeks after first dose)
Percentage of Participants With a Subject Self Rating Scale (SSRS) Response Baseline and 12 weeks after last treatment (up to 24 weeks after first dose)
Secondary Outcome
Measure Time Frame
Percentage of Participants With a CR-SMFRS 2-grade Response Baseline and 12 weeks after last treatment (up to 24 weeks after first dose)
Change From Baseline in CR-SMFRS Score Baseline and 12 weeks after last treatment (up to 24 weeks after first dose)
Change From Baseline in SSRS Scores Baseline and 12 weeks after last treatment (up to 24 weeks after first dose)
Change From Baseline in Submental Fat Thickness Baseline and 12 weeks after last treatment (up to 24 weeks after first dose)
Change From Baseline in Patient-reported Submental Fat Rating Scale (PR-SMFRS) Baseline and 12 weeks after last treatment (up to 24 weeks after first dose)
Change From Baseline in Patient-Reported Submental Fat Impact Scale (PR-SMFIS) Baseline and 12 weeks after last treatment (up to 24 weeks after first dose)
Change From Baseline in Self-rating of Attractiveness Baseline and 12 weeks after last treatment (up to 24 weeks after first dose)
Change From Baseline in Derriford Appearance Scale 24 (DAS24) Baseline and 12 weeks after last treatment (up to 24 weeks after first dose)
Change From Baseline in Body Image Quality of Life Inventory (BIQLI) Baseline and 12 weeks after last treatment (up to 24 weeks after first dose)
Enrollment 360
Condition
Intervention

Intervention Type: Drug

Intervention Name: Deoxycholic acid injection

Other Name: ATX-101

Intervention Type: Drug

Intervention Name: Placebo

Description: Phosphate buffered saline placebo for injection

Arm Group Label: Placebo

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.

Gender:

All

Minimum Age:

18 Years

Maximum Age:

65 Years

Healthy Volunteers:

Accepts Healthy Volunteers

Overall Official
Last Name Role Affiliation
Frederick Beddingfield, MD, PhD Study Director Kythera Biopharmaceuticals, Inc.
Location
Facility:
Investigational Site | Geel, 2440, Belgium
Investigational Site | Genk, 3600, Belgium
Investigational Site | Besançon, 25030, France
Investigational Site | Nice, 06000, France
Investigational Site | Paris, 75007, France
Investigational Site | Paris, 75116, France
Investigational Site | Rouen, 76100, France
Investigational Site | Recklinghausen, Nordrhein-Westfalen, 45657, Germany
Investigational Site | Berlin, 10827, Germany
Investigational Site | Berlin, 13705, Germany
Investigational Site | Bochum, 44791, Germany
Investigational Site | Dresden, 01067, Germany
Investigational Site | Dresden, 01097, Germany
Investigational Site | Erlangen, 91054, Germany
Investigational Site | Freiburg, 79104, Germany
Investigational Site | Hamburg, 20146, Germany
Investigational Site | Hamburg, 20354, Germany
Investigational Site | Kassel, 34121, Germany
Investigational Site | Lübeck, 23538, Germany
Investigational Site | Mahlow, 15831, Germany
Investigational Site | Monchengladbach, 41236, Germany
Investigational Site | Münster, 48159, Germany
Investigational Site | Regensburg, 93042, Germany
Investigational Site | Roma, 00185, Italy
Investigational Site | Madrid, 28043, Spain
Investigational Site | Birmingham, B74 2UG, United Kingdom
Investigational Site | Cardiff, CF10 2GF, United Kingdom
Investigational Site | London, W1G 8SF, United Kingdom
Investigational Site | Loughborough, LE11 1TZ, United Kingdom
Location Countries

Belgium

France

Germany

Italy

Spain

United Kingdom

Verification Date

2015-05-01

Responsible Party

Type: Sponsor

Has Expanded Access No
Number Of Arms 3
Arm Group

Label: Placebo

Type: Placebo Comparator

Description: Participants received placebo administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.

Label: Deoxycholic Acid Injection 1 mg/cm²

Type: Experimental

Description: Participants received deoxycholic acid 1 mg/cm² administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.

Label: Deoxycholic Acid Injection 2 mg/cm²

Type: Experimental

Description: Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.

Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Treatment

Masking: Double (Participant, Investigator)

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