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Long Term Follow-up Study on Safety and Maintenance of Efficacy of ATX-101

NCT02159729 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 205

Last updated 2020-02-17

Study results available
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Summary

This was a long-term follow-up study of participants who completed Kythera-sponsored trials of ATX-101 (06-03, 07-07, 09-15)

Conditions

  • Submental Fat
  • Healthy

Interventions

DRUG

Placebo

Clinical evaluation, patient reported outcome questionnaires, photographs, caliper measurements and recording adverse events

DRUG

ATX-101 (1 mg/cm^2)

Clinical evaluation, patient reported outcome questionnaires, photographs, caliper measurements and recording adverse events

DRUG

ATX-101 (2 mg/cm^2)

Clinical evaluation, patient reported outcome questionnaires, photographs, caliper measurements and recording adverse events

DRUG

ATX-101 (4 mg/cm^2)

Clinical evaluation, patient reported outcome questionnaires, photographs, caliper measurements and recording adverse events

Sponsors & Collaborators

  • Kythera Biopharmaceuticals

    lead INDUSTRY

Principal Investigators

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

Study Design

Allocation
NON_RANDOMIZED
Purpose
OTHER
Masking
DOUBLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2009-02-28
Primary Completion
2015-12-31
Completion
2015-12-31

Countries

  • United States
  • 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 NCT02159729 on ClinicalTrials.gov