Open-Label Study of Deoxycholic Acid for the Reduction of Localized Subcutaneous Fat in the Submental Area

NCT01426373 | Completed Phase 3 Results

• 1 other identifier: ATX-101-11-26
• Study Type: interventional
• Target: 165
• Locations: 1 country
• Sites: 18

Brief Summary

To evaluate the safety of deoxycholic acid subcutaneous injections in the submental area (below the chin).

Conditions

Moderate or Severe Submental Fullness

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Adverse Events (AEs)

  Serious AEs include any event that met one or more of the following criteria: was fatal or life-threatening, required inpatient hospitalization or prolonged a hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect or a significant medical hazard. The severity of each AE was defined as either: Mild: The participant was aware of the sign or symptom, but it was easily tolerated. Moderate: The sign or symptom caused discomfort and interfered with usual activity. Severe: The sign or symptom was incapacitating, and the participant was unable to engage in usual activity. The investigator determined the relationship of each AE to the study drug using the question: "Is there a reasonable possibility that the event may have been caused by treatment with the study drug?"

  Up to 12 months after last treatment (maximum of 18 months from first treatment)

Secondary Outcomes (11)

• Mean Change From Baseline in Clinician-Reported Submental Fat Rating Scale Scores (CR-SMFRS)

  Baseline and months 3, 6, 9, and 12 after last treatment

• Mean Change From Baseline in Patient-Reported Submental Fat Scale Rating Scale (PR-SMFRS)

  Baseline and month 3 and month 12 after last treatment

• Percentage of Participants Who Achieved a Composite 1-grade Response

  Baseline and month 3 and month 12 after last treatment

• Percentage of Participants Who Achieved a Composite 2-grade Response

  Baseline and month 3 and month 12 after last treatment

• Mean Change From Baseline in Patient-Reported Submental Fat Impact Scale (PR-SMFIS)

  Baseline and month 3 and month 12 after last treatment

Study Arms (1)

Deoxycholic Acid 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 6 treatments.

Drug: Deoxycholic acid injection

Interventions

Deoxycholic acid injection DRUG

Formulated as an injectable solution containing deoxycholic acid at a concentration of 10 mg/mL.

Also known as: ATX-101, Kybella

Deoxycholic Acid 2 mg/cm²

Eligibility Criteria

• Age: 18 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, 3, or 4 using the Clinician-Reported Submental Fat Rating Scale (CR-SMFRS) and graded by the subject as 2, 3, or 4 using the Patient-Reported Submental Fat Rating Scale (PR-SMFRS) as determined on visit 1 (within 28 days before the subject's first dosing session)
• Dissatisfaction with the submental area rated by the subject as 0, 1, or 2 using the Subject Self-rating Scale (SSRS) as determined on visit 1 (within 28 days before the subject's first dosing session)
• Males and nonpregnant, nonlactating females 18 years of age or greater, on the day of the subject's first dosing session (visit 2). Females of childbearing potential must have a negative human chorionic gonadotropin (serum) test result within 28 days before visit 2 and agree to practice adequate contraception, in the judgment of the investigator, during the course of the study
• A normal result on coagulation tests (prothrombin time (PT), partial thromboplastin time (PTT)) obtained within 28 days before subject's first dosing session
• History of stable body weight, in the judgment of the investigator, for at least 6 months before subject's first dosing session
• Expected to understand and comply with the visit schedule and all protocol-specified tests and procedures and agreement by the subject to refrain from making significant changes, in the judgment of the investigator, to his or her dietary or exercise habits during the course of the subject's participation
• Medically able to undergo the administration of study drug determined by clinical and laboratory tests obtained within 28 days before subject's first dosing session for which the investigator identifies 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 (eg, liposuction, surgery, or lipolytic agents)
• History of trauma associated with the chin or neck areas, which in the judgment of the investigator may affect evaluation of safety or efficacy of treatment
• A grade of 4 on the Submental Skin Laxity Grading scale (SMSLG) or any other anatomical feature (eg, predominant subplatysmal fat, loose skin in the neck or chin area, prominent platysmal bands) for which reduction in submental fat may, in the judgment of the investigator, result in an aesthetically unacceptable outcome
• Evidence of any cause of enlargement in the submental area (eg, thyroid enlargement, cervical adenopathy) other than localized submental fat
• Body mass index of ≥ 40 kg/m² as determined on visit 1 (week 0)
• History or current symptoms of dysphagia
• Any medical condition that would interfere with assessment of safety or efficacy or compromise the subject's ability to undergo study procedures or give informed consent
• Treatment with radio frequency, laser procedures, chemical peels, or dermal fillers in the neck or chin area within 12 months before the first treatment session, or botulinum toxin injections in the neck or chin area within 6 months before the first treatment session
• History of sensitivity to any components of the study drug or to topical or local anesthetics (eg, lidocaine, benzocaine, novocaine)
• Previous treatment in this study or previous participation in a Kythera-sponsored ATX-101 study
• Treatment with an investigational device or agent within 30 days before the subject's first treatment session

Sponsors & Collaborators

• Kythera Biopharmaceuticals: lead

Study Sites (18)

Mark Rubin

Beverly Hills, California, 90212, United States

Location

Mitchel Goldman

La Jolla, California, 92121, United States

Location

Jeffrey Klein

San Juan Capistrano, California, 92675, United States

Location

Ava Shamban

Santa Monica, California, 90404, United States

Location

Steven Teitelbaum

Santa Monica, California, 90404, United States

Location

Susan Weinkle

Bradenton, Florida, 34209, United States

Location

Palm Beach Cosmetic

West Palm Beach, Florida, 33401, United States

Location

Steven Dayan

Chicago, Illinois, 60611, United States

Location

Lupo Center for Aesthetic and General Dermatology

New Orleans, Louisiana, 70124, United States

Location

Grekin Skin Institute

Warren, Michigan, 48088, United States

Location

David Goldberg, MD

Hillsborough, New Jersey, 08844, United States

Location

Roy Geronemus, MD

New York, New York, 10016, United States

Location

Macrene Alexiades-Armenakas

New York, New York, 10028, United States

Location

Sue Ellen Cox

Chapel Hill, North Carolina, 27517, United States

Location

Richard Fried

Yardley, Pennsylvania, 19067, United States

Location

Michael Gold

Nashville, Tennessee, 37215, United States

Location

Suzanne Bruce

Houston, Texas, 77056, United States

Location

Jeffrey Adelglass

Plano, Texas, 75093, United States

Location

Related Publications (1)

• Beer K, Weinkle SH, Cox SE, Rubin MG, Shamban A, Somogyif C. ATX-101 (Deoxycholic Acid Injection) for Reduction of Submental Fat: Results From a 12-Month Open-Label Study. J Drugs Dermatol. 2019 Sep 1;18(9):870-877.

  PMID: 31524342 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 Biopharmaceuticals, Inc.

clinical_trials@kythera.com

Study Officials

• Frederick Beddingfield, III, M.D., 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: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 26, 2011
• First Posted: August 31, 2011
• Study Start: August 1, 2011
• Primary Completion: June 1, 2013
• Study Completion: June 1, 2013
• Last Updated: January 14, 2016
• Results First Posted: January 14, 2016

Record last verified: 2015-12

Locations

US (18)