Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 12:33 AM
Ignite Modification Date:
2025-12-25 @ 12:33 AM
NCT ID:
NCT02035267
Eligibility Criteria:
Inclusion Criteria:
* Male and female subjects, 18 to 65 years old
* Stable Body weight
* Body Mass Index (BMI) of ≤40.0 kg/m\^2
* Acceptable volume of submental fat graded by clinician
* Dissatisfaction with the submental area expressed by the subject
* Signed informed consent form (ICF)
* SMF ratings of 1 or 4
Exclusion Criteria:
* No prior intervention for submental fat (SMF) (eg, liposuction, surgery, or lipolytic agents)
* Presence of clinically significant health problems
* History of trauma associated with the chin or neck areas that in the judgment of the investigator may affect evaluation of safety or efficacy of treatment
* Body mass index ≤40 kg/m\^2
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT02035267
Study Brief:
Protocol Section:
NCT02035267