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

NCT01305577 | Completed Phase 3 Results

• 2 other identifiers: ATX-101-10-162010-020690-17
• Study Type: interventional
• Target: 363
• Locations: 5 countries
• Sites: 30

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

Outcome Measures

Primary Outcomes (2)

• Percentage of Participants With a Clinician-Reported Submental Fat Rating Scale (CR-SMFRS) 1-grade Response

  A CR-SMFRS response is defined as at least a 1-point improvement (i.e. 1-point reduction) from Baseline 12 weeks after the last treatment. 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.

  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

  A SSRS response is defined as an SSRS score that is 4 or greater 12 weeks after the last treatment. 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.

  Baseline and 12 weeks after last treatment (up to 24 weeks after first dose)

Secondary Outcomes (9)

• 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 Scores

  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)

Study Arms (3)

Placebo

PLACEBO COMPARATOR

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.

Drug: Placebo

Deoxycholic Acid Injection 1 mg/cm²

EXPERIMENTAL

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.

Drug: Deoxycholic acid injection

Deoxycholic Acid Injection 2 mg/cm²

EXPERIMENTAL

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.

Drug: Deoxycholic acid injection

Interventions

Deoxycholic acid injection DRUG

Also known as: ATX-101

Deoxycholic Acid Injection 1 mg/cm²; Deoxycholic Acid Injection 2 mg/cm²

Placebo DRUG

Phosphate buffered saline placebo for injection

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Dissatisfaction with the submental area rated by the subject as 0, 1, 2, or 3 using the Subject Self Rating Scale (SSRS).
• 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).
• 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.
• Expected to comply with and understand the visit schedule and all protocol-specified tests and procedures.
• 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.
• Signed informed consent obtained before any study-specific procedure is performed.

You may not qualify if:

• 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.
• 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).
• 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.
• Evidence of any cause of enlargement in the submental area (e.g., thyroid enlargement or cervical adenopathy) other than localized submental fat.
• Body mass index (BMI) greater than 30.
• Currently on or considering starting a weight reduction regimen.
• 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.
• 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.
• History of sensitivity to any components of the study material or to topical or local anesthetics (e.g., lidocaine, benzocaine, or novocaine).
• Previous randomization into this study or previous treatment with ATX-101.
• Treatment with an investigational device or agent within 30 days of randomization.

Sponsors & Collaborators

• Kythera Biopharmaceuticals: lead
• Bayer: collaborator

Study Sites (30)

Investigational Site

Oudenaarde, Minderbroederstaraat, 9700, Belgium

Location

Investigational Site

Arras, 62000, France

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Cannes, 06400, France

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Nice, 06202, France

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Pantin, 93500, France

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Paris, 75005, France

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Investigational Site

Paris, 75010, France

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Investigational Site

Augsburg, 86163, Germany

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Augsburg, 86179, Germany

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Berlin, 10117, Germany

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Darmstadt, 64297, Germany

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Frankfurt am Main, 60590, Germany

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Landau, 76829, Germany

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Ludwigshafen, 67061, Germany

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München, 80337, Germany

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Northeim, D-37154, Germany

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Potsdam, 14469, Germany

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Starnberg, 82319, Germany

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Wuppertal, 42275, Germany

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Barcelona, 08017, Spain

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Barcelona, 08022, Spain

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Barcelona, 08028, Spain

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Barcelona, 08034, Spain

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London, London, SW1 9QN, United Kingdom

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Salford, Manchester, M6 8HD, United Kingdom

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Northampton, Northampton, NN4 7BU, United Kingdom

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Nottingham, Nottingham, NG3 7DQ, United Kingdom

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Nottingham, Nottingham, NG9 8AR, United Kingdom

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Investigational Site

Plymouth, Plymouth, PL6 8BX, United Kingdom

Location

Investigational Site

Cheltenham, GL50 1QZ, United Kingdom

Location

Related Publications (1)

• McDiarmid J, Ruiz JB, Lee D, Lippert S, Hartisch C, Havlickova B. Results from a pooled analysis of two European, randomized, placebo-controlled, phase 3 studies of ATX-101 for the pharmacologic reduction of excess submental fat. Aesthetic Plast Surg. 2014 Oct;38(5):849-60. doi: 10.1007/s00266-014-0364-9. Epub 2014 Jul 2.

  PMID: 24984785 DERIVED

MeSH Terms

Conditions

Lymphoma, Follicular

Interventions

Deoxycholic Acid

Condition Hierarchy (Ancestors)

Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Cholic Acids; Bile Acids and Salts; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Cholanes

Results Point of Contact

• Title: Clinical Trial Disclosure
• Organization: Kythera

clinical_trials@kythera.com

Study Officials

• Frederick Beddingfield, MD, PhD

  Kythera Biopharmaceuticals, Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 10, 2011
• First Posted: February 28, 2011
• Study Start: December 1, 2010
• Primary Completion: January 1, 2012
• Study Completion: January 1, 2012
• Last Updated: July 14, 2015
• Results First Posted: June 15, 2015

Record last verified: 2015-06

Locations

ES (4); FR (6); BE (1); GB (7); DE (12)