Safety and Effectiveness of EN3835 in the Treatment of EFP in Women (NCT03329989) | Clinical Trial Compass
CompletedPhase 2
Safety and Effectiveness of EN3835 in the Treatment of EFP in Women
United States158 participantsStarted 2017-11-17
Plain-language summary
An open-label study of safety and effectiveness of EN3835 in the treatment of cellulite in adult women.
Who can participate
Age range
18 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Voluntarily sign and date an informed consent agreement
. Be a female ≥18 years of age
. At Screening visit, have at least 2 bilateral quadrants with each quadrant having:
. a score of 2 (mild) or greater as reported by the Investigator (CR-PCSS), and
. a Hexsel CSS score no greater than 13
. At Day 1 visit, have assigned bilateral quadrants with each quadrant having:
. a score of 2 (mild) or greater as reported by the Investigator (CR-PCSS), and
. a Hexsel CSS score no greater than 13
Exclusion criteria
. Has any of the following systemic conditions:
. Coagulation disorder
. Evidence or history of malignancy (other than excised basal-cell carcinoma) unless there has been no recurrence in at least 5 years
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
. History of keloidal scarring or abnormal wound healing
. Concurrent diseases or conditions that might interfere with the conduct of the study, confound the interpretation of the study results, or endanger the subject's well-being. Any questions about concurrent diseases should be discussed with the Medical Monitor.
. Evidence of clinically significant abnormalities on physical examination, vital signs, electrocardiogram (ECG), or clinical laboratory values.
. Has any of the following local conditions in the area to be treated:
. History of lower extremity thrombosis or post-thrombosis syndrome