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

Safety Clinical Trial

Official title:

A Multicenter, Double-blind, Placebo-controlled Safety Study of ATX-101 (Deoxycholic Acid) Injection for the Reduction of Localized Subcutaneous Fat in the Submental Area in Subjects 65 to 75 Years of Age

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02123134
• Other study ID #: ATX-101-13-28
• Status: Completed
• Phase: Phase 3
• Start date: April 2014
• Est. completion date: September 2015

Study information

• Verified date: January 2020
• Source: Kythera Biopharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 55
• Est. completion date: September 2015
• Est. primary completion date: August 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 65 Years to 75 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Efficacy
• Moderate to Severe Convexity of Submental Fat
• Safety

Intervention

Drug:
• ATX-101
Formulated as an injectable solution containing deoxycholic acid at a concentration of 10 mg/mL.
• Placebo
Phosphate buffered saline placebo for injection

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Kythera Biopharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)