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 @ 10:14 PM
Ignite Modification Date:
2025-12-24 @ 10:14 PM
NCT ID:
NCT05885035
Eligibility Criteria:
Inclusion Criteria:
* Females, 21-50 years old, of any race and ethnic background.
* 4-5 cellulite dimples that are no deeper than 1 cm each per buttock.
* Body fat between 9% and 55%.
* Written Authorization for Use and Release of Health and Research Study Information has been obtained.
* Ability to follow study instructions and likely to complete all required visits.
Exclusion Criteria:
* Males
* Females who are pregnant, breastfeeding, chronically using nonsteroidal anti-inflammatory drugs, have autoimmune conditions or have a known allergy to the study medications.
* Subjects with piercings or tattoos on the buttocks or those prone to getting keloids.
* Subjects with any aesthetic treatment in the buttocks.
* Subjects with minimal or excessive subcutaneous fat.
* Scars or ongoing infections in the target areas.
* Presence of any clinically significant bleeding disorder or is receiving medication that may increase the risk of bleeding as the result of treatment.
* Subject has a condition or is in a situation which, in the Investigator's opinion, may put the subject at significant risk, may confound the study results, or may interfere significantly with the subject's participation in the study.
* Any medical condition that would interfere with assessment of safety or efficacy or compromise the subject's ability to undergo study procedures or give informed consent.
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
21 Years
Maximum Age:
50 Years
Study:
NCT05885035
Study Brief:
Protocol Section:
NCT05885035