Facial Lipoatrophy, Facial Wrinkles, Lipodystrophy, Nasolabial Folds, Senile Skin Atrophy, Skin Aging
Conditions
Keywords
polydioxanone, PDO, dermal filler, biostimulator, nasolabial folds, wrinkle correction, facial rejuvenation, collagen stimulation, intradermal implant
Brief summary
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.
Detailed description
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.
Interventions
DEVICEAdministration of the prepared solution - 1 time Post injection observation - 30, 60, 160 days from the date of the first injection.
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.
Sponsors
Estelab Clinic
Pirogov National Medical Surgical Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
Yes
Inclusion criteria
* The subject has indications for use according to the manufacturer instructions for the device. * The subject is at least 18 years old at the time of signing the informed consent. * The subject expresses willingness and ability to follow the requirements of the study protocol. * The subject has no contraindications described in the device instructions for use.
Exclusion criteria
* The subject has at least one contraindication described in the device instructions for use, based on initial examination, laboratory tests and medical history. * Women of reproductive age: pregnancy, planning pregnancy during the study period, or breastfeeding. * Use of another product for the same indication during the clinical study. * Participation in another clinical study. * Pre-existing health problems that may compromise compliance with the study protocol. * Patients prone to excessive scarring. * Patients undergoing chemotherapy. * Patients previously treated with intradermal fillers in the planned injection zone with persistent effect.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Wrinkle Severity Rating Scale (WSRS) Score | Baseline, Day 30, Day 60, Day 160 after first injection | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Baker Ptosis Classification | Baseline, Day 30, Day 60, Day 160 after first injection | 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). |
| Global Aesthetic Improvement Scale (GAIS) - Investigator Assessment | Day 30, Day 60, Day 160 after first injection | 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). |
| Global Aesthetic Improvement Scale (GAIS) - Subject Self-Assessment | Day 30, Day 60, Day 160 after first injection | 5-point Global Aesthetic Improvement Scale (0 = worse, 4 = very much improved) assessed by the subject. Unit: Score on a scale (0-4). |
| Change in Perceived Age (Subject Self-Assessment) | Baseline, Day 30, Day 60, Day 160 after first injection | Subject self-assessment of perceived age before and after treatment. A reduction of at least 1 year is considered clinically meaningful. Unit: Years. |
| Change in Skin Parameters by Multi-Parametric Ultrasound | Baseline and Day 160 after first injection | 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). |
| Change in Lemperle Scale (Nasolabial Fold Depth) | Baseline, Day 30, Day 60, Day 160 after first injection | 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). |
| Number of Participants with Adverse Events (AEs) and Adverse Device Effects (ADEs) | From first injection through Day 160 (160-day follow-up) | 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. |
| Number of Participants with Serious Adverse Events (SAEs) and Serious Adverse Device Effects (SADEs) | From first injection through Day 160 (160-day follow-up) | 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. |
Countries
Russia
Outcome results
None listed