Quantitative Assessment of the Efficacy of Alidya

NCT07675356 | Completed

• 1 other identifier: KNW/0022/KB1/27/I/16
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 2

Brief 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

Keywords

Cellulite; Mesotherapy; Alidya; Skin imaging; Hyperspectral imaging; Thermal imaging; High-frequency ultrasound; Gynoid lipodystrophy

Outcome Measures

Primary Outcomes (1)

• Change from Baseline in Cellulite Severity (C Level) at 3 Months

  Cellulite severity was assessed by an expert using the Nürnberger-Müller scale, scored from 0 (no cellulite) to 4 (maximum changes), based on visual assessment in the standing position and palpation, taking into account skin unevenness, depressions, nodules, and the 'orange peel' sign.

  Baseline (T1) and 3 months after the first application (T3)

Secondary Outcomes (11)

• Change from Baseline in GLCM Contrast and Homogeneity of Skin Photographic Images at 3 Months

  Baseline (T1), 1 month (T2), and 3 months after the first application (T3)

• Change from Baseline in Quadtree Decomposition Fragmentation Indices of Skin Photographic Images at 3 Month

  Baseline (T1), 1 month (T2), and 3 months after the first application (T3)

• Change from Baseline in Thermal Imaging GLCM Contrast and Homogeneity at 3 Months

  Baseline (T1), 1 month (T2), and 3 months after the first application (T3)

• Change from Baseline in Hyperspectral Reflectance and Signal Heterogeneity Indices at 3 Months

  Baseline (T1), 1 month (T2), and 3 months after the first application (T3)

• Change from Baseline in Hyperspectral Spectral Slope at 3 Months

  Baseline (T1), 1 month (T2), and 3 months after the first application (T3)

Study Arms (1)

ALIDYA mesotherapy

EXPERIMENTAL

All 30 participants received a series of six needle mesotherapy treatments with ALIDYA, administered at weekly intervals to the posterior surfaces of both thighs. The preparation was injected intradermally or into the upper subcutaneous tissue at a depth of approximately 4 mm, using a point-by-point technique with 0.05-0.1 mL administered per injection site. Total volume per session was 10 mL (5 mL per thigh) for participants under 70 kg, or 20 mL (10 mL per thigh) for participants 70 kg or over. Assessments were performed at baseline (T1), one month after the first application (T2), and three months after the first application (T3).

Device: ALIDYA

Interventions

ALIDYA DEVICE

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).

ALIDYA mesotherapy

Eligibility Criteria

• Age: 20 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Medical University of Silesia: lead
• Marllor Biomedical: collaborator

Study Sites (2)

AJ Med

Mysłowice, 41-400, Poland

Location

Faculty of Pharmaceutical Sciences, Medical University of Silesia

Sosnowiec, 41-200, Poland

Location

Related Publications (8)

• Tsai J, Chien AL, Kang JU, Leung S, Kang S, Garza LA. Hyperspectral measurement of skin reflectance detects differences in the visible and near-infrared regions according to race, gender and body site. J Eur Acad Dermatol Venereol. 2021 May;35(5):e330-e333. doi: 10.1111/jdv.17076. Epub 2020 Dec 26. No abstract available.

  PMID: 33290609 BACKGROUND

• Zonios G, Bykowski J, Kollias N. Skin melanin, hemoglobin, and light scattering properties can be quantitatively assessed in vivo using diffuse reflectance spectroscopy. J Invest Dermatol. 2001 Dec;117(6):1452-7. doi: 10.1046/j.0022-202x.2001.01577.x.

  PMID: 11886508 BACKGROUND

• Emanuele E, Minoretti P, Altabas K, Gaeta E, Altabas V. Adiponectin expression in subcutaneous adipose tissue is reduced in women with cellulite. Int J Dermatol. 2011 Apr;50(4):412-6. doi: 10.1111/j.1365-4632.2010.04713.x.

  PMID: 21413950 BACKGROUND

• Rossi AB, Vergnanini AL. Cellulite: a review. J Eur Acad Dermatol Venereol. 2000 Jul;14(4):251-62. doi: 10.1046/j.1468-3083.2000.00016.x.

  PMID: 11204512 BACKGROUND

• Conti G, Zingaretti N, Amuso D, Dai Pre E, Brandi J, Cecconi D, Manfredi M, Marengo E, Boschi F, Riccio M, Amore R, Iorio EL, Busato A, De Francesco F, Riccio V, Parodi PC, Vaienti L, Sbarbati A. Proteomic and Ultrastructural Analysis of Cellulite-New Findings on an Old Topic. Int J Mol Sci. 2020 Mar 18;21(6):2077. doi: 10.3390/ijms21062077.

  PMID: 32197394 BACKGROUND

• Wilczynski S, Koprowski R, Deda A, Janiczek M, Kuleczka N, Blonska-Fajfrowska B. Thermographic mapping of the skin surface in biometric evaluation of cellulite treatment effectiveness. Skin Res Technol. 2017 Feb;23(1):61-69. doi: 10.1111/srt.12301. Epub 2016 Jun 5.

  PMID: 27264715 BACKGROUND

• Bass LS, Kaminer MS. Insights Into the Pathophysiology of Cellulite: A Review. Dermatol Surg. 2020 Oct;46 Suppl 1(1):S77-S85. doi: 10.1097/DSS.0000000000002388.

  PMID: 32976174 BACKGROUND

• Terranova F, Berardesca E, Maibach H. Cellulite: nature and aetiopathogenesis. Int J Cosmet Sci. 2006 Jun;28(3):157-67. doi: 10.1111/j.1467-2494.2006.00316.x.

  PMID: 18489272 BACKGROUND

MeSH Terms

Conditions

Cellulite

Condition Hierarchy (Ancestors)

Skin Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Sławomir Wilczyński, Profesor

  Department of Basic Biomedical Science, Faculty of Pharmaceutical Sciences in Sosnowiec, Medical Universi-ty of Silesia in Katowice, Poland

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: All participants received the same intervention (a series of six ALIDYA mesotherapy treatments) and were assessed at three time points: baseline (T1), one month after the first application (T2), and three months after the first application (T3), serving as their own comparison over time.

Study Record Dates

• First Submitted: June 22, 2026
• First Posted: June 30, 2026
• Study Start: March 1, 2025
• Primary Completion: April 30, 2026
• Study Completion: April 30, 2026
• Last Updated: June 30, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

PL (2)