Quantitative Assessment of the Efficacy of Alidya (NCT07675356) | Clinical Trial Compass
CompletedNot Applicable
Quantitative Assessment of the Efficacy of Alidya
Poland30 participantsStarted 2025-03-01
Plain-language summary
This study evaluated the efficacy of ALIDYA, a Class III medical device used in needle mesotherapy, for the treatment of cellulite (gynoid lipodystrophy) in women. Thirty female volunteers aged 20-45 years with cellulite graded 1 to 4 on the Nürnberger-Müller scale received a series of six mesotherapy treatments administered weekly to the posterior thighs. The study aimed to determine whether this treatment could improve the clinical appearance of cellulite and produce measurable changes in skin structure, microcirculation, and tissue composition. Assessments were performed before treatment, one month after the first application, and three months after the first application, using expert clinical grading as well as several objective instrumental methods: standardized clinical photography with texture analysis, thermal imaging, hyperspectral imaging, three-dimensional skin surface analysis (Antera 3D), and high-frequency ultrasound. The hypothesis was that ALIDYA would reduce the severity of cellulite by improving skin surface topography, microcirculation, and the structural quality of the skin.
Who can participate
Age range
20 Years – 45 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 gender
* Age between 20 and 45 years
* Presence of clinically detectable cellulite, graded 1 to 4 on the Nürnberger-Müller scale
* Significant aesthetic defect on the posterior surfaces of the thighs, confirmed by visual assessment in the standing position and palpation
* Stable body weight in the period preceding the study
* No contraindications to mesotherapy
* Provision of informed consent to participate in the treatment procedures, photographic documentation, and instrumental assessment
Exclusion Criteria:
* Concurrent participation in other cellulite treatments, invasive or non-invasive
* Pregnancy or breastfeeding
* Significant systemic diseases
* Severe organ failure
* Coagulation disorders
* Treatment with immunosuppressants or systemic steroids
* History of or active thromboembolic disease
* Significant venous insufficiency
* Presence of implanted devices or metal implants in the treatment area
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
Change from Baseline in Cellulite Severity (C Level) at 3 Months
Timeframe: Baseline (T1) and 3 months after the first application (T3)