Quantitative Assessment of the Efficacy of Alidya
Efficacy of Alidya Needle Mesotherapy in the Treatment of Cellulite: A Prospective Multimodal Clinical and Instrumental Evaluation
研究概览
详细说明
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.
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
-
-
-
Mysłowice、波兰、41-400
- AJ Med
-
Sosnowiec、波兰、41-200
- Faculty of Pharmaceutical Sciences, Medical University of Silesia
-
-
参与标准
资格标准
适合学习的年龄
- 成人
接受健康志愿者
描述
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
学习计划
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:不适用
- 介入模型:单组作业
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的:ALIDYA mesotherapy
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).
|
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).
|
研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Change from Baseline in Cellulite Severity (C Level) at 3 Months
大体时间: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.
|
Baseline (T1) and 3 months after the first application (T3)
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Change from Baseline in GLCM Contrast and Homogeneity of Skin Photographic Images at 3 Months
大体时间: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.
|
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
大体时间: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
|
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
大体时间: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.
|
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
大体时间: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.
|
Baseline (T1), 1 month (T2), and 3 months after the first application (T3)
|
|
Change from Baseline in Hyperspectral Spectral Slope at 3 Months
大体时间: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).
|
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
大体时间: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.
|
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
大体时间: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.
|
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
大体时间: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.
|
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
大体时间: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.
|
Baseline (T1), 1 month (T2), and 3 months after the first application (T3)
|
|
Change from Baseline in Skin Thickness (Ultrasound) at 3 Months
大体时间: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.
|
Baseline (T1), 1 month (T2), and 3 months after the first application (T3)
|
|
Change from Baseline in Skin Acoustic Density (Ultrasound) at 3 Months
大体时间: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.
|
Baseline (T1), 1 month (T2), and 3 months after the first application (T3)
|
合作者和调查者
调查人员
- 首席研究员:Sławomir Wilczyński, Profesor、Department of Basic Biomedical Science, Faculty of Pharmaceutical Sciences in Sosnowiec, Medical Universi-ty of Silesia in Katowice, Poland
出版物和有用的链接
一般刊物
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他相关的 MeSH 术语
其他研究编号
- KNW/0022/KB1/27/I/16
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)?
药物和器械信息、研究文件
研究美国 FDA 监管的药品
研究美国 FDA 监管的设备产品
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.