Study Aimed at Evaluation of the Effectiveness and Tolerability of an Anti-cellulite Cream Medica… (NCT06348615) | Clinical Trial Compass
CompletedNot Applicable
Study Aimed at Evaluation of the Effectiveness and Tolerability of an Anti-cellulite Cream Medical Device
Italy56 participantsStarted 2024-01-24
Plain-language summary
Post-marketing clinical study conducted on a CE medical device, named Defense Body, cellulite treatment, edematous fibrosclerotic panniculopathy (2nd and 3rd stage pathology), reducing draining cream-gel, to verify its effectiveness and tolerability on a panel of 56 subjects females affected by 2nd and 3rd degree PEF. The effectiveness of the device is measured in terms of reduction in thigh circumference, improvement in the appearance of the skin with reduction of the orange peel appearance and improvement in skin smoothness.
Who can participate
Age range
18 Years – 55 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:
* Female sex;
* Age between 18 and 55;
* Presence of grade II or III symmetrical cellulite on the right and left lower limbs;
* BMI between 18.5 and 30;
* Good state of health and absence of chronic pathologies;
* Willingness not to change one's lifestyle during study;
* Willingness to join the study and sign the information consent.
Exclusion Criteria:
* Subjects being treated with other topical products in the lower limbs;
* Subjects being treated with other topical or systemic cellulite products;
* Subjects with skin conditions and/or inflammatory conditions underway or had in the period immediately preceding the start of the study;
* Subjects with a history of venous or lymphatic insufficiency in the lower limbs;
* Subjects with known allergies or intolerances to one of the components of the product;
* Pregnant or breastfeeding subjects;
* Subjects undergoing slimming therapy, whether pharmacological or dietary;
* Subjects who practice intense or competitive sporting activity.
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
First day of study initiation: clinical history; personal and demographic data and previous or concomitant treatments
Timeframe: First day: within 24 hours
2
First day of study initiation: BMI
Timeframe: First day: within 24 hours
3
First day of study initiation: Measurement of waist circumference, hip circumference and thigh circumference
Timeframe: First day: within 24 hours
4
First day of study initiation: digital photographs of the area to be treated
Timeframe: First day: within 24 hours
5
First day of study initiation: skin profilemetry of the thigh