MedTrace Logo

Phase 2 Study of Deoxycholic Acid Injection (ATX-101) for the Reduction of Submental Fat

NCT00618618 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 73

Last updated 2015-07-14

Study results available
· View outcomes & findings →

Summary

Phase 2 trial to evaluate the safety and potential efficacy of one concentration of deoxycholic acid injection, given in three dosing paradigms, compared to placebo for the reduction of submental fat (fat beneath the chin).

Conditions

  • Moderate or Severe Submental Fullness

Interventions

DRUG

Deoxycholic Acid Injection

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

DRUG

Placebo

Sponsors & Collaborators

  • Kythera Biopharmaceuticals

    lead INDUSTRY

Principal Investigators

  • Frederick Beddingfield, III, M.D., Ph.D. · Kythera Biopharmaceuticals, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
25 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-04-30
Primary Completion
2008-12-31
Completion
2008-12-31

Countries

  • Australia
  • Canada
  • United Kingdom

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 NCT00618618 on ClinicalTrials.gov