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| Name | Class |
|---|---|
| Pirogov National Medical Surgical Center | OTHER_GOV |
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Study of the effectiveness of the medical device "Intradermal implant, sterile ULTRACOL based on polydioxanone (ULTRA V Co., Ltd., Korea) in the correction of skin contour defects.
The investigational product is composed of a mixture of polydioxanone and sodium carboxymethylcellulose. The polydioxanone content is as follows: Ultracol 200: 150 mg ±10%, Ultracol 100: 75 mg ±10%. The key difference from the closest analogs (AestheFill® V200, Sculptra™, Ellagen PLLA+CMC 1000 mg) is the presence of polydioxanone in the investigational product.
Thus, the analyzed analogues are not fully interchangeable medical products. The combined composition of Ultracol has not been studied properly. Therefore, during the clinical study, it is necessary to check the safety and effectiveness of a medical product with a combined composition - polydioxanone and sodium carboxymethylcellulose.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental Group | Experimental | ULTRACOL Intradermal Implant (Polydioxanone-based). All 23 adult subjects (22 female, 3 male; mean age 51.1, range 37-70) received intradermal injections of ULTRACOL using linear-retrograde technique into the lower dermis or hypodermis. ULTRACOL 100 (100 mg/vial, reconstituted in 1 mL water for injection) used in all 23 patients; ULTRACOL 200 (200 mg/vial, reconstituted in 2 mL water for injection) used in 20 patients. Mean 1.87 injections per patient. Maximum dose: 3 mL per procedure. Treatment zones: nasolabial folds, cheeks, zygomatic area, perioral/periauricular regions, facial oval. Follow-up: Day 30, 60, 160. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Administration of the prepared solution - 1 time Post injection observation - 30, 60, 160 days from the date of the first injection. | Device | Lyophilized intradermal implant based on polydioxanone (PDO) and sodium carboxymethylcellulose (Na-CMC). ULTRACOL 100: 100 mg/vial (75 mg PDO), reconstituted in 1 mL water for injection. ULTRACOL 200: 200 mg/vial (150 mg PDO), reconstituted in 2 mL water for injection. Administered intradermally using linear-retrograde technique. Maximum dose: 3 mL per procedure. Mean 1.87 injections per subject. Manufactured by ULTRA V Co., Ltd., Republic of Korea. Class III medical device. Biostimulating mechanism: PDO hydrolysis stimulates neocollagenesis. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Wrinkle Severity Rating Scale (WSRS) Score | Validated 5-point scale (1 = no wrinkles, 5 = extreme wrinkles) assessed by the investigator. A reduction of 1 or more points compared to baseline is considered clinically significant. Units: Score on a scale (1-5). | Baseline, Day 30, Day 60, Day 160 after first injection |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Baker Ptosis Classification | 4-grade classification of facial soft tissue ptosis assessed by the investigator (Grade I = minimal, Grade IV = severe). Unit: Score on a scale (I-IV). | Baseline, Day 30, Day 60, Day 160 after first injection |
| Global Aesthetic Improvement Scale (GAIS) - Investigator Assessment |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Estelab CLinic | Moscow | Russia | 119034 | Russia |
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| ID | Term |
|---|---|
| D008060 | Lipodystrophy |
| ID | Term |
|---|---|
| D012875 | Skin Diseases, Metabolic |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D052439 | Lipid Metabolism Disorders |
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A study without a control group, without a comparison device, blinding and randomization are not required. In order to increase the clinical significance and generalizability of the data, the inclusion/exclusion criteria and requirements for the treatment plan are formulated as openly as possible, without compromising the reliability of the data.
The observation period more than covers the period for assessing the safety of the device. The studied MD does not enter the systemic circulation, therefore, safety issues may arise upon direct administration or slightly later.
The results of toxicological studies and sterility studies are confirmed within the framework of this clinical trial program. Residual clinical risks requiring additional study within the framework of the current program have not been identified.
The existing clinical experience of using the medical device in question in other countries confirms the suitability of use in accordance with the instructions for use.
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5-point Global Aesthetic Improvement Scale (0 = worse, 1 = no change, 2 = improved, 3 = much improved, 4 = very much improved) assessed by the investigator. Unit: Score on a scale (0-4). |
| Day 30, Day 60, Day 160 after first injection |
| Global Aesthetic Improvement Scale (GAIS) - Subject Self-Assessment | 5-point Global Aesthetic Improvement Scale (0 = worse, 4 = very much improved) assessed by the subject. Unit: Score on a scale (0-4). | Day 30, Day 60, Day 160 after first injection |
| Change in Perceived Age (Subject Self-Assessment) | Subject self-assessment of perceived age before and after treatment. A reduction of at least 1 year is considered clinically meaningful. Unit: Years. | Baseline, Day 30, Day 60, Day 160 after first injection |
| Change in Skin Parameters by Multi-Parametric Ultrasound | Multi-parametric facial skin ultrasound assessing: epidermis thickness (mm), papillary dermis thickness (mm), reticular dermis thickness (mm), subcutaneous fat thickness (mm), vascularization index (%), dermis stiffness via compression elastography (kPa). Unit: Combined imaging parameters reported per individual measurement (mm / % / kPa). | Baseline and Day 160 after first injection |
| Change in Lemperle Scale (Nasolabial Fold Depth) | 5-point Lemperle scale for assessment of nasolabial fold depth (0 = no wrinkle, 5 = very deep wrinkle), assessed by the investigator. Unit: Score on a scale (0-5). | Baseline, Day 30, Day 60, Day 160 after first injection |
| Number of Participants with Adverse Events (AEs) and Adverse Device Effects (ADEs) | Frequency and severity of adverse events (AEs) and adverse device effects (ADEs), assessed by the investigator and recorded throughout the study. Unit: Number of Participants. | From first injection through Day 160 (160-day follow-up) |
| Number of Participants with Serious Adverse Events (SAEs) and Serious Adverse Device Effects (SADEs) | Frequency of serious adverse events (SAEs) and serious adverse device effects (SADEs), assessed by the investigator and recorded throughout the study. Unit: Number of Participants. | From first injection through Day 160 (160-day follow-up) |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |