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

NCT02035267 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 93

Last updated 2020-02-17

Study results available
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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.

Conditions

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

Interventions

DRUG

Deoxycholic Acid

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

DRUG

Placebo

Phosphate buffered saline placebo for injection.

Sponsors & Collaborators

  • Kythera Biopharmaceuticals

    lead INDUSTRY

Principal Investigators

  • Frederick Beddingfield, III, MD, PhD · Sponsor GmbH

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2014-01-31
Primary Completion
2015-06-30
Completion
2015-06-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02035267 on ClinicalTrials.gov