Safety Study of ATX-101 (Deoxycholic Acid) in Subjects With Mild or Extreme Fullness of Submental Fat

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 With Clinician-Reported Submental Fat Rating Scale (CR-SMFRS) Grade 1 or CR-SMFRS Grade 4

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02035267
• Other study ID #: ATX-101-13-27
• Status: Completed
• Phase: Phase 3
• Start date: January 2014
• Est. completion date: June 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 in patients with mild or extreme fullness of the submental fat and ratings of 1 or 4.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 93
• Est. completion date: June 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Male and female subjects, 18 to 65 years old

• Stable Body weight

• Body Mass Index (BMI) of =40.0 kg/m^2

• Acceptable volume of submental fat graded by clinician

• Dissatisfaction with the submental area expressed by the subject

• Signed informed consent form (ICF)

• SMF ratings of 1 or 4

Exclusion Criteria:

• No prior intervention for submental fat (SMF) (eg, liposuction, surgery, or lipolytic agents)

• Presence of clinically significant health problems

• History of trauma associated with the chin or neck areas that in the judgment of the investigator may affect evaluation of safety or efficacy of treatment

• Body mass index =40 kg/m^2

Related Conditions & MeSH terms

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

Intervention

Drug:
• Deoxycholic Acid
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 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 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)