Efficacy of Alidya Needle Mesotherapy in the Treatment of Cellulite: A Prospective Multimodal Clinical and Instrumental Evaluation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Change from Baseline in Cellulite Severity (C Level) at 3 Months
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Change from Baseline in Cellulite Severity (C Level) at 3 Months
时间窗: 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.
次要结局
- 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))
- 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))
- 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))
- 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))
- 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))
- Change from Baseline in Skin Thickness (Ultrasound) at 3 Months(Baseline (T1), 1 month (T2), and 3 months after the first application (T3))
- Change from Baseline in Skin Acoustic Density (Ultrasound) at 3 Months(Baseline (T1), 1 month (T2), and 3 months after the first application (T3))