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Quantitative Assessment of the Efficacy of Alidya
Sponsor: Medical University of Silesia
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.
Official title: Efficacy of Alidya Needle Mesotherapy in the Treatment of Cellulite: A Prospective Multimodal Clinical and Instrumental Evaluation
Key Details
Gender
FEMALE
Age Range
20 Years - 45 Years
Study Type
INTERVENTIONAL
Enrollment
30
Start Date
2025-03-01
Completion Date
2026-04-30
Last Updated
2026-06-30
Healthy Volunteers
No
Conditions
Interventions
ALIDYA
ALIDYA is supplied as a 340 mg lyophilisate, dissolved in 10 mL of solvent immediately before administration to form an injectable solution. The formulation is a polyamino acid gel containing gelatine hydrolysate, mannitol, calcium ascorbate, amino acids, EDTA, β-cyclodextrin, sodium chloride and sodium bicarbonate. It was administered via needle mesotherapy, in a series of six sessions at weekly intervals, with 0.05-0.1 mL injected per site, and a total session volume of 10 mL or 20 mL depending on body weight (\<70 kg or ≥70 kg, respectively).
Locations (2)
AJ Med
Mysłowice, Poland
Faculty of Pharmaceutical Sciences, Medical University of Silesia
Sosnowiec, Poland