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

NCT ID: NCT01294644

Last Updated: 2015-06-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 360 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-01-31
• Study Completion Date: 2012-02-29

Brief Summary

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

Conditions

Moderate or Severe Submental Fullness

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Placebo

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.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Phosphate buffered saline placebo for injection

Deoxycholic Acid Injection 1 mg/cm²

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.

Group Type: EXPERIMENTAL

Deoxycholic acid injection

Intervention Type: DRUG

Deoxycholic Acid Injection 2 mg/cm²

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.

Group Type: EXPERIMENTAL

Deoxycholic acid injection

Intervention Type: DRUG

Interventions

Deoxycholic acid injection

Intervention Type: DRUG

Placebo

Phosphate buffered saline placebo for injection

Intervention Type: DRUG

Other Intervention Names

ATX-101

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Bayer

INDUSTRY

Sponsor Role: collaborator

Kythera Biopharmaceuticals

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Frederick Beddingfield, MD, PhD

Role: STUDY_DIRECTOR

Kythera Biopharmaceuticals, Inc.

Locations

Investigational Site

Geel, , Belgium

Investigational Site

Genk, , Belgium

Investigational Site

Besançon, , France

Investigational Site

Nice, , France

Investigational Site

Paris, , France

Investigational Site

Paris, , France

Investigational Site

Rouen, , France

Investigational Site

Recklinghausen, North Rhine-Westphalia, Germany

Investigational Site

Berlin, , Germany

Investigational Site

Berlin, , Germany

Investigational Site

Bochum, , Germany

Investigational Site

Dresden, , Germany

Investigational Site

Dresden, , Germany

Investigational Site

Erlangen, , Germany

Investigational Site

Freiburg im Breisgau, , Germany

Investigational Site

Hamburg, , Germany

Investigational Site

Hamburg, , Germany

Investigational Site

Kassel, , Germany

Investigational Site

Lübeck, , Germany

Investigational Site

Mahlow, , Germany

Investigational Site

Mönchengladbach, , Germany

Investigational Site

Münster, , Germany

Investigational Site

Regensburg, , Germany

Investigational Site

Roma, , Italy

Investigational Site

Madrid, , Spain

Investigational Site

Birmingham, , United Kingdom

Investigational Site

Cardiff, , United Kingdom

Investigational Site

London, , United Kingdom

Investigational Site

Loughborough, , United Kingdom

Countries

Belgium; France; Germany; Italy; Spain; United Kingdom

Other Identifiers

2010-020691-28

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

ATX-101-10-17

Identifier Type: -

Identifier Source: org_study_id