Study of the Subdermal Implant "Ultracol"

Estelab Clinic

Status: Completed

Conditions: Senile Skin Atrophy; Nasolabial Folds; Skin Aging; Lipodystrophy; Facial Wrinkles; Facial Lipoatrophy

Treatments: Device: Administration of the prepared solution - 1 time Post injection observation - 30, 60, 160 days from the date of the first injection.

Study type: Interventional

Funder types: Other; NETWORK

Identifiers

NCT07617350

060-КИ-МИ-2024

Details and patient eligibility

About

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.

Full 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.

Enrollment: 23 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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23 participants in 1 patient group

Experimental Group

Experimental group

Description:

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.

Treatment:

Device: Administration of the prepared solution - 1 time Post injection observation - 30, 60, 160 days from the date of the first injection.