Safety Study of Deoxycholic Acid for the Reduction of Localized Subcutaneous Fat in the Submental Area in Subjects 65 to 75 Years of Age

NCT02123134 | Completed Phase 3 Results

• 1 other identifier: ATX-101-13-28
• Study Type: interventional
• Target: 55
• Locations: 1 country
• Sites: 6

Brief Summary

The objectives of this study are to explore the safety and efficacy of subcutaneous injections of Deoxycholic Acid relative to placebo, in the submental area of participants who are 65 to 75 years old.

Conditions

Moderate to Severe Convexity of Submental Fat; Safety; Efficacy

Outcome Measures

Primary Outcomes (7)

• Percentage of Participants With at Least a 1-Grade Reduction (Improvement) at 12 Weeks From Last Treatment Based on Both the Clinician-Reported Submental Fat Rating Scale (CR-SMFRS) and Patient-Reported Submental Fat Rating Scale (PR-SMFRS) Assessments

  The investigator evaluated the participant's chin and neck area using the Clinician-Reported Submental Fat Rating Scale (a 5-point scale) where: 0=absent submental convexity (best) to 4= extreme submental convexity (worst). The participant evaluated their chin and neck area using the Patient-Reported Submental Fat Rating Scale (a 5-point scale) where: 0=no chin fat at all (best) to 4= a very large amount of chin fat (worst).

  Baseline and up to Week 32 (12 weeks after last treatment)

• Percentage of Participants With at Least a 2-Grade Reduction (Improvement) at 12 Weeks From Last Treatment Based on Both the Clinician-Reported Submental Fat Rating Scale (CR-SMFRS) and Patient-Reported Submental Fat Rating Scale (PR-SMFRS) Assessments

  The investigator evaluated the participant's chin and neck area using the Clinician-Reported Submental Fat Rating Scale (a 5-point scale) where: 0=absent submental convexity (best) to 4= extreme submental convexity (worst). The participant evaluated their chin and neck area using the Patient-Reported Submental Fat Rating Scale (a 5-point scale) where: 0=no chin fat at all (best) to 4= a very large amount of chin fat (worst).

  Baseline and up to Week 32 (12 weeks after last treatment)

• Percentage of Participants With at Least a 1-Grade Reduction (Improvement) at 12 Weeks From Last Treatment Based on the Clinician-Reported Submental Fat Rating Scale (CR-SMFRS)

  The investigator evaluated the participant's chin and neck area using the CR-SMFRS 5-point scale where: 0=absent submental convexity (best) to 4= extreme submental convexity (worst).

  Baseline and up to Week 32 (12 weeks after last treatment)

• Percentage of Participants With at Least a 2-Grade Reduction (Improvement) at 12 Weeks From Last Treatment Based on the Clinician-Reported Submental Fat Rating Scale (CR-SMFRS)

  The investigator evaluated the participant's chin and neck area using the CR-SMFRS 5-point scale where: 0=absent submental convexity (best) to 4= extreme submental convexity (worst).

  Baseline and up to Week 32 (12 weeks after last treatment)

• Percentage of Participants With at Least a 1-Grade Reduction (Improvement) at 12 Weeks From Last Treatment Based on the Patient-Reported Submental Fat Rating Scale (PR-SMFRS)

  The participant evaluated their chin and neck area using the PR-SMFRS 5-point scale where: 0=no chin fat at all (best) to 4= a very large amount of chin fat (worst).

  Baseline and up to Week 32 (12 weeks after last treatment)

• Percentage of Participants With at Least a 2-Grade Reduction (Improvement) at 12 Weeks From Last Treatment Based on the Patient-Reported Submental Fat Rating Scale (PR-SMFRS)

  The participant evaluated their chin and neck area using the PR-SMFRS 5-point scale where: 0=no chin fat at all (best) to 4= a very large amount of chin fat (worst).

  Baseline and up to Week 32 (12 weeks after last treatment)

• Change From Baseline in Submental Skin Laxity Grade Scale (SMSLG)

  The SMSLG is an integration of three features: skin wrinkling, adherence to underlying neck structures (bone and muscle) and redundancy (horizontal and vertical folds). Each grade (1=none, 2=mild, 3=moderate and 4=severe) defines the maximal allowed limit for skin wrinkling, adherence to underlying structures and redundancy.

  Baseline and up to Week 32 (12 weeks after last treatment)

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Participants received placebo administered in 0.2 mL subcutaneous (SC) injections, up to 10 milliliters (mL) per treatment session at intervals of approximately 1 month for up to a maximum of 6 treatments.

Drug: Placebo

ATX-101 deoxycholic acid injection

EXPERIMENTAL

Participants received deoxycholic acid 2 mg/cm\^2 administered in 0.2 mL SC injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 6 treatments.

Drug: ATX-101

Interventions

ATX-101 DRUG

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

Also known as: deoxycholic acid

ATX-101 deoxycholic acid injection

Placebo DRUG

Phosphate buffered saline placebo for injection

Placebo

Eligibility Criteria

• Age: 65 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• Males and females, 65 to 75 years of age
• Stable Body Weight
• Dissatisfaction with the submental area expressed by participants
• Acceptable volume of submental fat graded by clinician
• BMI of ≤40.0 kg/m\^2
• Signed informed consent (ICF)
• SMF rating of 2 or 3 by clinician and patient

You may not qualify if:

• No prior intervention for submental fat (SMF) (eg liposuction, surgery or lipolytic agents)
• Absence of clinically significant health problems
• Anatomical features for which reduction in SMF may result in aesthetically unacceptable outcome, judged by clinician
• History of trauma associated with the chin or neck areas that in the judgment of the investigator may affect evaluation of safety or efficacy
• Body mass index of ≥40.0 kg/m\^2

Sponsors & Collaborators

• Kythera Biopharmaceuticals: lead

Study Sites (6)

Unknown Facility

Birmingham, Alabama, 35205, United States

Location

Unknown Facility

Los Angeles, California, 90036, United States

Location

Unknown Facility

Bradenton, Florida, 34209, United States

Location

Unknown Facility

Metairie, Louisiana, 70006, United States

Location

Unknown Facility

White Plains, New York, 10604, United States

Location

Unknown Facility

Cincinnati, Ohio, 45255, United States

Location

MeSH Terms

Interventions

Deoxycholic Acid

Intervention Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Beta Bowen
• Organization: Allergan, Inc

Bowen_Beta@allergan.com

714-246-4446

Study Officials

• Frederick Beddingfield, III, MD, PhD

  Sponsor GmbH

  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: April 22, 2014
• First Posted: April 25, 2014
• Study Start: April 1, 2014
• Primary Completion: August 1, 2015
• Study Completion: September 1, 2015
• Last Updated: February 17, 2020
• Results First Posted: February 17, 2020

Record last verified: 2020-01

Locations

US (6)