Study of the Subdermal Implant "Ultracol"
2026年5月25日 更新者：Estelab Clinic
A Single-center Clinical Study of the Efficacy and Safety of the Medical Device "Intradermal Implant, Sterile ULTRACOL Based on Polydioxanone (ULTRA V Co., Ltd., Korea) in the Correction of Skin Contour Defects.
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.
調査の概要
状態
完了
詳細な説明
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.
研究の種類
介入
入学 (実際)
23
段階
- 適用できない
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
-
-
Russia
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Moscow、Russia、ロシア、119034
- Estelab CLinic
-
-
参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
はい
説明
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.
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：なし
- 介入モデル：単一グループの割り当て
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的：Experimental Group
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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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.
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Change in Wrinkle Severity Rating Scale (WSRS) Score
時間枠：Baseline, Day 30, Day 60, Day 160 after first injection
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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).
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Baseline, Day 30, Day 60, Day 160 after first injection
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Change in Baker Ptosis Classification
時間枠：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).
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Baseline, Day 30, Day 60, Day 160 after first injection
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Global Aesthetic Improvement Scale (GAIS) - Investigator Assessment
時間枠：Day 30, Day 60, Day 160 after first injection
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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).
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Day 30, Day 60, Day 160 after first injection
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Global Aesthetic Improvement Scale (GAIS) - Subject Self-Assessment
時間枠：Day 30, Day 60, Day 160 after first injection
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5-point Global Aesthetic Improvement Scale (0 = worse, 4 = very much improved) assessed by the subject.
Unit: Score on a scale (0-4).
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Day 30, Day 60, Day 160 after first injection
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Change in Perceived Age (Subject Self-Assessment)
時間枠：Baseline, Day 30, Day 60, Day 160 after first injection
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Subject self-assessment of perceived age before and after treatment.
A reduction of at least 1 year is considered clinically meaningful.
Unit: Years.
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Baseline, Day 30, Day 60, Day 160 after first injection
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Change in Skin Parameters by Multi-Parametric Ultrasound
時間枠：Baseline and Day 160 after first injection
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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).
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Baseline and Day 160 after first injection
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Change in Lemperle Scale (Nasolabial Fold Depth)
時間枠：Baseline, Day 30, Day 60, Day 160 after first injection
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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).
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Baseline, Day 30, Day 60, Day 160 after first injection
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Number of Participants with Adverse Events (AEs) and Adverse Device Effects (ADEs)
時間枠：From first injection through Day 160 (160-day follow-up)
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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.
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From first injection through Day 160 (160-day follow-up)
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Number of Participants with Serious Adverse Events (SAEs) and Serious Adverse Device Effects (SADEs)
時間枠：From first injection through Day 160 (160-day follow-up)
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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.
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From first injection through Day 160 (160-day follow-up)
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協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (実際)
2024年7月16日
一次修了 (実際)
2025年3月12日
研究の完了 (実際)
2025年4月10日
試験登録日
最初に提出
2024年10月23日
QC基準を満たした最初の提出物
2026年5月25日
最初の投稿 (実際)
2026年6月1日
学習記録の更新
投稿された最後の更新 (実際)
2026年6月1日
QC基準を満たした最後の更新が送信されました
2026年5月25日
最終確認日
2026年5月1日
詳しくは
本研究に関する用語
その他の研究ID番号
- 060-КИ-МИ-2024
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
いいえ
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
いいえ
米国FDA規制機器製品の研究
いいえ
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