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:
2025-12-26 @ 5:17 PM
Ignite Modification Date:
2025-12-26 @ 5:17 PM
NCT ID:
NCT05199506
Eligibility Criteria:
Inclusion Criteria:
* Seeking treatment of cellulite in the thigh and/or buttock areas
* Area of moderate to severe cellulite on thigh and/or buttock for both legs 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.
* Body Mass Index (B.M.I.) is ≤ 30
* Participant will not have had invasive or energy-based cellulite treatments (liposuction, subcision, RF, laser, ESWT, etc.) for the prior 12 months.
* Participant will not have used topical based cellulite treatments for prior 6 months and will not use during the trial.
* Participant will not have used spray-on tanning treatments for 6 months prior to the initiation of the trial. Furthermore, participants will not use spray-on tanning treatments during the term of the trial.
* Participants must be able to provide written informed consent, understand and is willing to comply with all study related procedures and follow-up visits.
Exclusion Criteria:
* Participant is unwilling to have research photos taken of treatment areas in the presence of Sponsor's researchers.
* Participant is unwilling to have RAP treatment provided in the presence of Sponsor's researchers.
* Participant is pregnant or planning to become pregnant during the duration of the study.
* Participant is unwilling to commit to follow-up visits
* Metal or plastic implants in the area of the treatment (vascular stent, or implants in the hips, knees, etc.).
* Active electronic implants such as pacemakers, defibrillators.
* History of coagulopathy(ies) and/or on anticoagulant medication.
* Skin disorders (skin infections or rashes, extensive scarring, psoriasis, etc.) in the treatment area.
* Any surgical procedure in the treatment areas in the prior 3 months or planned during the duration of the study.
* Participant is a current smoker.
* Participant has tattoo in treatment area.
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
55 Years
Study:
NCT05199506
Study Brief:
Protocol Section:
NCT05199506