Overview

This trial is active, not recruiting.

Condition pain measurement
Treatments thermal, pharmaceutical, mechanical
Phase phase 3
Sponsor Kythera Biopharmaceuticals
Start date October 2013
End date May 2014
Trial size 80 participants
Trial identifier NCT02007434, ATX-101-13-36

Summary

The objectives of this study are to determine the safety of ATX-101 subcutaneous (SC) injections in the submental area and to evaluate the effects of four interventions, relative to placebo in the submental area, particularly with regard to assessment and management of pain, bruising, and swelling/edema.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety study
Intervention model parallel assignment
Masking double blind (subject, investigator)
Primary purpose treatment
Arm
(Placebo Comparator)
Adverse Event Management Paradigms
thermal
cold
pharmaceutical
analgesics/anesthetics/antihistamines
mechanical
compression
(Active Comparator)
Adverse Event Management Paradigms
thermal
cold
pharmaceutical
analgesics/anesthetics/antihistamines
mechanical
compression

Primary Outcomes

Measure
Pain assessment using VAS
time frame: 84 days
Pain assessment using McGill Pain Questionnaire
time frame: 84 days
Categorical assessment of swelling
time frame: 84 days
Categorical assessment of bruising
time frame: 84 days
Categorical assessment of induration
time frame: 84 days

Secondary Outcomes

Measure
Efficacy assessments using a clinician rating scale
time frame: 84 days
Efficacy assessments using a patient reported rating scale
time frame: 84 days
Efficacy assessments using the subject self rating scale
time frame: 84 days
Efficacy assessments using submental skin laxity grade
time frame: 84 days
Efficacy assessments on submental fat using calipers
time frame: 84 days

Eligibility Criteria

Male or female participants from 18 years up to 65 years old.

Inclusion Criteria: 1. Sufficient volume of submental fat graded by the investigator 2. Dissatisfaction with the submental area expressed by the subject a 3. Males and nonpregnant, nonlactating females 18 to 65 years of age 4. History of stable body weight for at least 6 months and body mass index (BMI) of ≤40 kg/m2. 5. Acceptable skin laxity as determined by the investigator 6. Agreement by the subject to refrain from making significant changes, in the documented judgment of the investigator, to his or her dietary or exercise habits during the course of the subject's participation. 7. Agreement to forego any treatment or behavior (e.g., unshaven facial hair) 8. Signed informed consent obtained before any study-specific procedure is performed. Exclusion Criteria: 1. No prior intervention for SMF or recent cosmetic procedure in the neck or chin area 2. Absence of clinically significant health problems 3. Body mass index >40.0 kg/m2 as determined prior to randomization. 4. History of drug or alcohol abuse.

Additional Information

Official title A Single Center, Double-blind, Parallel-group, Two Factor Patient Experience Management Study of ATX-101 (Deoxycholic Acid Injection) for the Reduction of Localized Subcutaneous Fat in the Submental Area
Description This is to evaluate the effects of four interventions, pre- and post-SC injections of ATX 101 relative to placebo in approximately 80 subjects. Subjects will be randomized to either ATX-101 or placebo at a ratio of 4:1. Approximately 64 subjects will receive ATX 101 and approximately 16 subjects will receive placebo in one of four Patient Experience Management Paradigms. Subjects are required to visit the research facility on 10 separate occasions for protocol-defined treatments, procedures, tests, and observations.
Trial information was received from ClinicalTrials.gov and was last updated in April 2014.
Information provided to ClinicalTrials.gov by Kythera Biopharmaceuticals.