CelluliteNCT07675356
Quantitative Assessment of the Efficacy of Alidya
A study testing ALIDYA in people with Cellulite and Gynoid Lipodystrophy, run by Medical University of Silesia at 2 sites in Poland.
Trial 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… Read more about this study
- Who is it for?
- Ages 20 to 45 years, women only
- Conditions the study is for
- Cellulite, Gynoid Lipodystrophy
- What is being tested?
- ALIDYA
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 2 sitesPoland
- Study dates
- 1 Mar 2025to 30 Apr 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- History of or active thromboembolic disease
- Significant venous insufficiency
- Presence of implanted devices or metal implants in the treatment area
Trial locations and contacts
2 sites in 1 country.
Poland2 sites
AJ Med
Mysłowice, 41-400
Faculty of Pharmaceutical Sciences, Medical University of Silesia
Sosnowiec, 41-200
About this study
Official title: Efficacy of Alidya Needle Mesotherapy in the Treatment of Cellulite: A Prospective Multimodal Clinical and Instrumental Evaluation
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.
Read the 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.
- Conditions
- Cellulite, Gynoid Lipodystrophy
- Being tested
- ALIDYA
- Keywords
- Cellulite, Mesotherapy, Alidya, Skin imaging, Hyperspectral imaging, Thermal imaging, High-frequency ultrasound, Gynoid lipodystrophy
- Medical subject headings
- Cellulite
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ALIDYADevice
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).
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Device: ALIDYA |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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.
Measured: 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
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
Measured: 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
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.
Measured: 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
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.
Measured: Baseline (T1), 1 month (T2), and 3 months after the first application (T3)
Change from Baseline in Hyperspectral Spectral Slope at 3 Months
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).
Measured: 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
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.
Measured: 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
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.
Measured: 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
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.
Measured: 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
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.
Measured: Baseline (T1), 1 month (T2), and 3 months after the first application (T3)
Change from Baseline in Skin Thickness (Ultrasound) at 3 Months
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.
Measured: Baseline (T1), 1 month (T2), and 3 months after the first application (T3)
Change from Baseline in Skin Acoustic Density (Ultrasound) at 3 Months
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.
Measured: Baseline (T1), 1 month (T2), and 3 months after the first application (T3)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2026
- Study start1 Mar 2025
- Primary completion30 Apr 2026
- Study completion30 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for CelluliteStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- 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.
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Silesia
- Sponsor type
- University, hospital or other
- Collaborators
- Marllor Biomedical
- Responsible party
- Sponsor
- Investigators
- Sławomir Wilczyński, Profesor, Principal investigator, Department of Basic Biomedical Science, Faculty of Pharmaceutical Sciences in Sosnowiec, Medical Universi-ty of Silesia in Katowice, Poland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07675356
- Sponsor's protocol ID
- KNW/0022/KB1/27/I/16
- Status last verified
- Jun 2026
- First submitted
- 22 Jun 2026
- Last updated
- 30 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 33290609Zonios 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.
PubMed 11886508Emanuele 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.
PubMed 21413950Rossi 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.
PubMed 11204512Conti 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.
PubMed 32197394Wilczynski 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.
PubMed 27264715Bass 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.
PubMed 32976174Terranova 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.
PubMed 18489272
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Alidya Needle Mesotherapy in the Treatment of Cellulite: A Prospective Multimodal Clinical and Instrumental Evaluation
- ClinicalTrials.gov ID
- NCT07675356
- Acronym / sponsor ID
- KNW/0022/KB1/27/I/16
- Conditions
- Cellulite, Gynoid Lipodystrophy
- Keywords
- Cellulite, Mesotherapy, Alidya, Skin imaging, Hyperspectral imaging, Thermal imaging, High-frequency ultrasound, Gynoid lipodystrophy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Medical University of SilesiaUniversity, hospital or other
- Collaborators
- Marllor Biomedical
- Study start
- 1 Mar 2025 (actual)
- Primary completion
- 30 Apr 2026 (actual)
- Study completion
- 30 Apr 2026 (actual)
- First posted
- 30 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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.
| Arm | Type | Receives |
|---|---|---|
| ALIDYA mesotherapy | Experimental | Device: ALIDYAAll 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). |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (9 listed)
- Concurrent participation in other cellulite treatments, invasive or non-invasive
- Pregnancy or breastfeeding
- Significant systemic diseases
- Severe organ failure
- Coagulation disorders
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ALIDYAALIDYA 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). | Device | ALIDYA mesotherapy |
Primary outcome
Change from Baseline in Cellulite Severity (C Level) at 3 Months
Time frame: 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.
11 secondary outcomes
Change from Baseline in GLCM Contrast and Homogeneity of Skin Photographic Images at 3 Months
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Baseline (T1), 1 month (T2), and 3 months after the first application (T3)
Change from Baseline in Hyperspectral Spectral Slope at 3 Months
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Baseline (T1), 1 month (T2), and 3 months after the first application (T3)
Change from Baseline in Skin Thickness (Ultrasound) at 3 Months
Time frame: Baseline (T1), 1 month (T2), and 3 months after the first application (T3)
Change from Baseline in Skin Acoustic Density (Ultrasound) at 3 Months
Time frame: Baseline (T1), 1 month (T2), and 3 months after the first application (T3)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jun 2026.
- Background: PubMed 33290609Tsai 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.
- Background: PubMed 11886508Zonios 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.
- Background: PubMed 21413950Emanuele 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.
- Background: PubMed 11204512Rossi 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.
- Background: PubMed 32197394Conti 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.
- Background: PubMed 27264715Wilczynski 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.
- Background: PubMed 32976174Bass 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.
- Background: PubMed 18489272Terranova 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sławomir Wilczyński, Profesor principal investigator
Department of Basic Biomedical Science, Faculty of Pharmaceutical Sciences in Sosnowiec, Medical Universi-ty of Silesia in Katowice, Poland
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ALIDYA in people with Cellulite and Gynoid Lipodystrophy, run by Medical University of Silesia at 2 sites in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline in Cellulite Severity (C Level) at 3 Months (time frame: Baseline (T1) and 3 months after the first application (T3)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07675356, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jun 2026.