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Quantitative Assessment of the Efficacy of Alidya

NCT07675356 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2026-06-30

No results posted yet for this study

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.

Conditions

  • Cellulite
  • Gynoid Lipodystrophy

Interventions

DEVICE

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).

Sponsors & Collaborators

  • Marllor Biomedical

    collaborator UNKNOWN

  • Medical University of Silesia

    lead OTHER

Principal Investigators

  • Sławomir Wilczyński, Profesor · Department of Basic Biomedical Science, Faculty of Pharmaceutical Sciences in Sosnowiec, Medical Universi-ty of Silesia in Katowice, Poland

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
20 Years
Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-03-01
Primary Completion
2026-04-30
Completion
2026-04-30

Countries

  • Poland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07675356 on ClinicalTrials.gov