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

Kythera Biopharmaceuticals

Status and phase: Completed; Phase 3

Conditions: Efficacy; Moderate to Severe Convexity of Submental Fat; Safety

Treatments: Drug: Placebo; Drug: ATX-101

Study type: Interventional

Funder types: Industry

Identifiers

NCT02123134

ATX-101-13-28

Details and patient eligibility

About

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.

Enrollment: 55 patients

Sex: All

Ages: 65 to 75 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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55 participants in 2 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

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.

Treatment:

Drug: Placebo

ATX-101 deoxycholic acid injection

Experimental group

Description:

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.

Treatment:

Drug: ATX-101