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:
2025-12-24 @ 10:30 PM
Ignite Modification Date:
2025-12-24 @ 10:30 PM
NCT ID:
NCT05730335
Eligibility Criteria:
Inclusion Criteria:
* Participants seeking treatment of cellulite in the thigh and/or buttock areas.
* Areas of moderate to severe cellulite on bilateral thigh and/or buttock using the Cellulite Dimple - At Rest Scale at Baseline with grades of 2 or 3 based on review of photos taken under the same lightening conditions planned for the trial.
* Participant will not have had invasive or energy-based cellulite (liposuction, subcision, RF, laser, ESWT, cryo-lipolysis, muscle stimulation, etc.) treatments in the treatment areas in the prior 12 months.
* Participant will not have used topical based cellulite treatments for prior 3 months and will not use during the trial
* Participant will not have used spray-on tanning treatments for 3 months prior to or during the term of the trial.
Exclusion Criteria:
* Metal or plastic implants (vascular stent, or implants in the hips, knees, etc.) in the treatment areas.
* Active electronic implants such as pacemakers, defibrillators
* History of coagulopathy and/or on anticoagulant medication
* Skin disorders (skin infections or rashes, psoriasis, etc.) in the treatment areas.
* Medical disorder that would hinder wound healing or immune response.
* Any surgical procedure in the treatment areas in the prior 3 months or planned during the duration of the study.
* Any other condition/disease/situation which, as deemed by the PI, would preclude participant from safely participating in or completing the study visits or that may confound study results.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
50 Years
Study:
NCT05730335
Study Brief:
Protocol Section:
NCT05730335