Clinical trial NCT01426373: Open-Label Study of Deoxycholic Acid for the Reduction of Localized Subcutaneous Fat in the Submental Area
Official title: Multicenter, Open-label Study of ATX-101 (Sodium Deoxycholate Injection) 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
First posted: 2011-08-31
Enrollment: 165
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Number of Participants With Adverse Events (AEs)
timeFrame: Up to 12 months after last treatment (maximum of 18 months from first treatment)
Secondary outcomes:
measure: Mean Change From Baseline in Clinician-Reported Submental Fat Rating Scale Scores (CR-SMFRS)
timeFrame: Baseline and months 3, 6, 9, and 12 after last treatment
measure: Mean Change From Baseline in Patient-Reported Submental Fat Scale Rating Scale (PR-SMFRS)
timeFrame: Baseline and month 3 and month 12 after last treatment
measure: Percentage of Participants Who Achieved a Composite 1-grade Response
timeFrame: Baseline and month 3 and month 12 after last treatment
measure: Percentage of Participants Who Achieved a Composite 2-grade Response
timeFrame: Baseline and month 3 and month 12 after last treatment
measure: Mean Change From Baseline in Patient-Reported Submental Fat Impact Scale (PR-SMFIS)
timeFrame: Baseline and month 3 and month 12 after last treatment
measure: Mean Change From Baseline in Subject Self Rating Scale (SSRS)
timeFrame: Baseline and month 3 and month 12 after last treatment
measure: Mean Change From Baseline in Self-rating of Attractiveness
timeFrame: Baseline and month 3 and month 12 after last treatment
measure: Response to Subject Global Questions
timeFrame: Month 3 and month 12 after last treatment
measure: Percent Change From Baseline in Submental Fat Thickness
timeFrame: Baseline and month 3 and month 12 after last treatment
measure: Change From Baseline in Submental Skin Laxity Grade (SMSLG)
timeFrame: Baseline and month 3 and month 12 after last treatment
measure: Change From Baseline in Line Drawing Assessment
timeFrame: Baseline and month 3 after last treatment
Other outcomes:
Locations:
city: Beverly Hills
country: United States
facility: Mark Rubin
state: California
city: LaJolla
country: United States
facility: Mitchel Goldman
state: California
city: San Juan Capistrano
country: United States
facility: Jeffrey Klein
state: California
city: Santa Monica
country: United States
facility: Ava Shamban
state: California
city: Santa Monica
country: United States
facility: Steven Teitelbaum
state: California
city: Bradenton
country: United States
facility: Susan Weinkle
state: Florida
city: West Palm Beach
country: United States
facility: Palm Beach Cosmetic
state: Florida
city: Chicago
country: United States
facility: Steven Dayan
state: Illinois
city: New Orleans
country: United States
facility: Lupo Center for Aesthetic and General Dermatology
state: Louisiana
city: Warren
country: United States
facility: Grekin Skin Institute
state: Michigan
city: Hillsborough
country: United States
facility: David Goldberg, MD
state: New Jersey
city: New York
country: United States
facility: Roy Geronemus, MD
state: New York
city: New York
country: United States
facility: Macrene Alexiades-Armenakas
state: New York
city: Chapel Hill
country: United States
facility: Sue Ellen Cox
state: North Carolina
city: Yardley
country: United States
facility: Richard Fried
state: Pennsylvania
city: Nashville
country: United States
facility: Michael Gold
state: Tennessee
city: Houston
country: United States
facility: Suzanne Bruce
state: Texas
city: Plano
country: United States
facility: Jeffrey Adelglass
state: Texas
Study officials:
affiliation: Kythera Biopharmaceuticals, Inc
name: Frederick Beddingfield, III, M.D., PhD
role: STUDY_DIRECTOR
References:
citation: 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.