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 @ 12:38 AM
Ignite Modification Date:
2025-12-25 @ 12:38 AM
NCT ID:
NCT01209767
Eligibility Criteria:
Inclusion Criteria:
* Healthy female patients 18-60 years of age with more than one evident depressed lesion of cellulite on the upper thighs and/or buttocks.
* All subjects must have the affected areas that show the mattress phenomenon spontaneously when standing or while both lying and standing (Stage 2 or 3 of Nurnberger-Muller grading scale of cellulite7).
* Subjects who are willing and have the ability to understand and provide informed consent for participation in the study and are able to communicate with the investigator.
Exclusion Criteria:
* Pregnant or lactating
* Subjects who are unable to understand the protocol or to give informed consent.
* Subjects currently under treatment with an antiplatelet or anticoagulant for any medical problem or patients who have coagulation disorder.
* Subjects who have a known history of cold-induced disease such as cryoglobulinemia, paroxysmal cold hemoglobinuria, or cold urticaria.
* Subjects who have active skin disease or skin infection in treatment area.
* Subjects who are allergic to lidocaine or prilocaine.
* Subjects who are allergic to both cephalexin (and penicillin) AND levofloxacin (or another quinolone antibiotic).
* Subjects who have history of abnormal scarring.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
60 Years
Study:
NCT01209767
Study Brief:
Protocol Section:
NCT01209767