Effects of Mitigation Treatments on Bruising of CCH-aaes Treatment of Buttock Cellulite (NCT04677712) | Clinical Trial Compass
CompletedPhase 4
Effects of Mitigation Treatments on Bruising of CCH-aaes Treatment of Buttock Cellulite
United States48 participantsStarted 2020-12-28
Plain-language summary
This study will investigate treatments that may mitigate bruising after QWO™ (Collagenase clostridium histolyticum \[CCH\]-aaes) treatment of cellulite in the buttocks.
Who can participate
Age range
18 Years – 50 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
. Have both buttocks with:
. Clinician Reported Photonumeric Cellulite Severity Scale (CR-PCSS) score of 3 (moderate) as reported by the Investigator, and
. Hexsel Cellulite Severity Scale (CSS) Subsection D "Grade of laxity, flaccidity, or sagging skin" score of 0 (absence of laxity, flaccidity, or sagging skin) or 1 (slightly draped appearance).
. Have a body mass index between ≥18 and ≤30 kilograms (kg)/square meter (m\^2).
. Be willing to apply sunscreen before each exposure to the sun while participating in the study (that is, Baseline through end of study).
. Be judged to be in good health.
. Be willing and able to cooperate with the requirements of the study.
Exclusion criteria
. Has a coagulation disorder including but not limited to a Factor II, V, VII, or X deficiency.
. Has local conditions in the areas to be treated (thrombosis, vascular disorder, active infection/inflammation, active cutaneous alteration, tattoo/mole) that restricts study participation.
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.
What they're measuring
1
Number of Participants by Buttock at Each Level of Bruising on the Investigator Assessment of Bruising Severity Scale at Day 4
Timeframe: Day 4 (3 days after CCH-aaes injection)
Trial details
NCT IDNCT04677712
SponsorEndo USA Inc., a Keenova Therapeutics Company
. Has skin laxity or linear undulations on buttocks that can be effaced by lifting skin.
. Requires the following concomitant medications during the study and cannot discontinue these medications within the time specified before CCH-aaes treatment.
. Antiplatelet medication (clopidogrel \[Plavix®\] including aspirin at any dose within 14 days of treatment.
. Anticoagulants, such as warfarin (Coumadin®); heparin analogues within 14 days of treatment.
. Non-steroidal anti-inflammatory drugs (NSAIDS), such as ibuprofen (Motrin®, Advil®) and naproxen (Aleve®) 7 days before the study.
. Any medications or food that have or have been reported to have anticoagulant effects within 14 days of treatment.