Cellulite, Gynoid Lipodystrophy
Conditions
Keywords
Cellulite, Mesotherapy, Alidya, Skin imaging, Hyperspectral imaging, Thermal imaging, High-frequency ultrasound, Gynoid lipodystrophy
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.
Detailed description
ALIDYA is a Class III medical device manufactured by Marllor Biomedical (Italy), supplied as a 340 mg lyophilisate dissolved in 10 mL of solvent immediately before administration. The formulation is a polyamino acid gel containing gelatine hydrolysate, mannitol, calcium ascorbate, amino acids, EDTA, β-cyclodextrin, sodium chloride and sodium bicarbonate, and is intended to target the microcirculatory, oedematous, oxidative and fibrotic components of cellulite. The treatment protocol consisted of six mesotherapy sessions performed at weekly intervals. The preparation was administered using a point-by-point microinjection technique into the dermis or upper subcutaneous layer, to a depth of approximately 4 mm, with a spacing of approximately 1.5 cm between injection sites, delivering 0.05-0.1 mL per point. Total volume per session was adjusted to body weight: 10 mL per session (5 mL per thigh) for participants under 70 kg, and 20 mL per session (10 mL per thigh) for participants 70 kg or over. The treatment area covered the posterior surfaces of both thighs, from approximately 5 cm above the popliteal fossa to the gluteal line. Assessments were performed at baseline (T1), one month after the first application (T2), and three months after the first application (T3). Clinical assessment used the Nürnberger-Müller scale (C Level). Instrumental assessments included: standardized clinical photography under cross-polarized light with Gray-Level Co-occurrence Matrix (GLCM) texture analysis and Quadtree Decomposition (QTDCOMP) spatial analysis; thermal imaging analyzed via GLCM contrast and homogeneity; hyperspectral imaging (400-1000 nm) with extraction of haemoglobin-, water- and heterogeneity-related spectral metrics; three-dimensional skin surface analysis (Antera 3D) for indentation volume, texture, and erythema; and high-frequency ultrasound (22 MHz) for skin thickness and acoustic density.
Interventions
DEVICEALIDYA
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
Medical University of Silesia
Marllor Biomedical
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
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.
Eligibility
Sex/Gender
FEMALE
Age
20 Years to 45 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from Baseline in Cellulite Severity (C Level) at 3 Months | Baseline (T1) and 3 months after the first application (T3) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change from Baseline in Skin Erythema Parameters (Antera 3D) at 3 Months | Baseline (T1), 1 month (T2), and 3 months after the first application (T3) | Skin erythema was assessed using the Antera 3D imaging system, which measures four parameters: Redness Score (overall erythema intensity), Minimum and Maximum (lower and upper range of erythema signal intensity), and Uniformity (uniformity of erythema distribution within the region of interest). A decrease in Redness Score, Minimum, and Maximum was interpreted as a reduction in the vascular-erythemal component of cellulite. All parameters were assessed separately for the left and right thigh. |
| Change from Baseline in Skin Thickness (Ultrasound) at 3 Months | Baseline (T1), 1 month (T2), and 3 months after the first application (T3) | Skin structure was assessed using high-frequency (22 MHz) ultrasound, which measures Skin Thickness (in mm), the distance from the entry echo to the dermal-subcutaneous boundary. An increase in Skin Thickness was interpreted as a favorable sign of dermal remodeling and increased collagen matrix organization. This parameter was assessed separately for the left and right thigh. |
| 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) | Skin texture was assessed using Gray-Level Co-occurrence Matrix (GLCM) analysis of standardized clinical photographs taken under cross-polarized light. GLCM Contrast quantifies local brightness variation (higher values indicate more pronounced surface irregularities); GLCM Homogeneity quantifies overall image uniformity (higher values indicate smoother, more even skin). Both parameters were assessed separately for the left and right thigh. |
| 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) | Skin surface fragmentation was assessed using Quadtree Decomposition (QTDCOMP) analysis of standardized clinical photographs, which divides the image into homogeneous square blocks ranging from 2×2 to 128×128 pixels. A higher number of small squares (2×2 to 32×32 pixels) indicates greater structural fragmentation and irregularity, typical of more severe cellulite. A higher number of large squares (64×64 and 128×128 pixels) indicates smoother, more homogeneous skin areas. Square counts were assessed separately for the left and right thigh |
| 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) | Skin thermal texture was assessed using Gray-Level Co-occurrence Matrix (GLCM) analysis of infrared thermograms. GLCM Contrast quantifies local temperature variation (higher values indicate greater thermal heterogeneity, e.g. adjacent hypothermic and hyperthermic skin areas typical of cellulite). GLCM Homogeneity quantifies overall thermal map uniformity (higher values indicate more even temperature distribution). Both parameters were assessed separately for the left and right thigh. |
| 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) | Skin optical properties were assessed using hyperspectral imaging (400-1000 nm) via dimensionless reflectance-based indices. Metrics included: mean reflectance in the haemoglobin-sensitive band (500-570 nm) and near-infrared range (700-900 nm); depth of the haemoglobin absorption dip at \~560 nm (HbDepth560); reflectance ratio indices R560/R650 and R577/R650; the water index (970/800 nm); and signal heterogeneity metrics (mean spread, standard deviation of spread, coefficient of variation of spread) describing spatial variability within the region of interest. All metrics are dimensionless ratios or proportions. An increase in reflectance and ratio indices, a decrease in haemoglobin dip depth, and a decrease in heterogeneity metrics were interpreted as indicating improved microcirculation and reduced optical heterogeneity of the skin. |
| Change from Baseline in Hyperspectral Spectral Slope at 3 Months | Baseline (T1), 1 month (T2), and 3 months after the first application (T3) | Skin optical properties were assessed using hyperspectral imaging (400-1000 nm) via the slope of the reflectance curve, expressed in units of reflectance change per nanometer (1/nm). Spectral slope was measured in the visible range (500-600 nm) and near-infrared range (700-900 nm). An increase in slope was interpreted as a change in the overall shape of the reflectance spectrum, associated with reduced haemoglobin-related absorption (visible range) or altered scattering and tissue structure (near-infrared range). |
| Change from Baseline in Skin Indentation Volume (Antera 3D) at 3 Months | Baseline (T1), 1 month (T2), and 3 months after the first application (T3) | Skin surface depressions were assessed using the Antera 3D imaging system, which measures the volume of skin indentations (Volume, in mm³) within the region of interest. A higher Volume value indicates greater depth and extent of skin depressions, corresponding to more pronounced cellulite. A decrease in Volume was interpreted as a favorable reduction in skin depression depth and surface smoothing. Volume was assessed separately for the left and right thigh. |
| Change from Baseline in Skin Texture Score and Roughness (Antera 3D) at 3 Months | Baseline (T1), 1 month (T2), and 3 months after the first application (T3) | Skin surface texture was assessed using the Antera 3D imaging system, which measures two dimensionless parameters: Texture Score (a composite measure of textural abnormality severity) and Roughness (degree of surface irregularity). Higher values for both parameters indicate greater skin unevenness; a decrease following treatment was interpreted as surface smoothing and reduced severity of skin micro-relief. Both parameters were assessed separately for the left and right thigh. |
| Change from Baseline in Skin Acoustic Density (Ultrasound) at 3 Months | Baseline (T1), 1 month (T2), and 3 months after the first application (T3) | Skin structure was assessed using high-frequency (22 MHz) ultrasound, which measures Acoustic Density/Echogenicity (in IU), reflecting the degree of ultrasound wave reflection by tissue matrix structures. An increase in Acoustic Density was interpreted as a favorable sign of increased collagen matrix organization and reduced interstitial oedema. This parameter was assessed separately for the left and right thigh. |
| Change from Baseline in Skin Texture Maximum Height (Antera 3D) at 3 Months | Baseline (T1), 1 month (T2), and 3 months after the first application (T3) | Skin surface texture was assessed using the Antera 3D imaging system, which measures Texture Maximum Height (in mm), the greatest height difference within the region of interest. A higher value indicates greater skin unevenness; a decrease following treatment was interpreted as surface smoothing and reduced severity of skin micro-relief. This parameter was assessed separately for the left and right thigh. |
Countries
Poland
Contacts
PRINCIPAL_INVESTIGATORSławomir Wilczyński, Profesor
Department of Basic Biomedical Science, Faculty of Pharmaceutical Sciences in Sosnowiec, Medical Universi-ty of Silesia in Katowice, Poland
Outcome results
None listed