Study of the Subdermal Implant "Ultracol"

NCT07617350 | Completed DMC

• 1 other identifier: 060-КИ-МИ-2024
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

polydioxanone; PDO; dermal filler; biostimulator; nasolabial folds; wrinkle correction; facial rejuvenation; collagen stimulation; intradermal implant

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (8)

• Change in Baker Ptosis Classification

  Baseline, Day 30, Day 60, Day 160 after first injection

• Global Aesthetic Improvement Scale (GAIS) - Investigator Assessment

  Day 30, Day 60, Day 160 after first injection

• Global Aesthetic Improvement Scale (GAIS) - Subject Self-Assessment

  Day 30, Day 60, Day 160 after first injection

• Change in Perceived Age (Subject Self-Assessment)

  Baseline, Day 30, Day 60, Day 160 after first injection

• Change in Skin Parameters by Multi-Parametric Ultrasound

  Baseline and Day 160 after first injection

Study Arms (1)

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.

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

Interventions

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.

Experimental Group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Estelab Clinic: lead
• Pirogov National Medical Surgical Center: collaborator

Study Sites (1)

Estelab CLinic

Moscow, Russia, 119034, Russia

Location

MeSH Terms

Conditions

Lipodystrophy

Condition Hierarchy (Ancestors)

Skin Diseases, Metabolic; Skin Diseases; Skin and Connective Tissue Diseases; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: October 23, 2024
• First Posted: June 1, 2026
• Study Start: July 16, 2024
• Primary Completion: March 12, 2025
• Study Completion: April 10, 2025
• Last Updated: June 1, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

RU (1)