Safety and Efficacy Evaluation of the Radiofrequency Therapeutic Device for the Treatment of Atrophic Acne Scars
2026년 5월 29일 업데이트: CLASSYS Inc.
A Prospective, Multicenter, Randomized, Parallel-Controlled, Blinded-Assessment, Non-Inferiority Clinical Trial to Evaluate the Safety and Effectiveness of a Radiofrequency Therapeutic Device for the Treatment of Atrophic Acne Scars
The objective of this clinical trial is to evaluate the safety and effectiveness of a radiofrequency treatment device for the treatment of atrophic acne scars.
This is a prospective, multicenter, randomized, parallel-controlled, blinded-assessment, non-inferiority trial design.
The study aims to evaluate the effectiveness and safety of the radiofrequency therapeutic device manufactured by Sponsor for the treatment of atrophic acne scars, in comparison with the control device, the radiofrequency therapeutic device.
Participants will receive treatment sessions using either the investigational device or the control device, undergo follow-up evaluations after treatment to assess efficacy and safety outcomes.
The primary endpoint is Improvement in atrophic acne scars measured by the ECCA score compared with baseline, assessed 12 weeks after the final treatment.
The secondary efficacy endpoints include Global Aesthetic Improvement Scale (GAIS), Study Participant Satisfaction Assessment, Pain Score, Changes in skin characteristics compared with baseline Safety evaluations include Adverse events (AEs), Serious adverse events (SAEs)
연구 개요
상태
아직 모집하지 않음
연구 유형
중재적
등록 (추정된)
252
단계
- 해당 없음
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 연락처
- 이름: SOYOUNG CHOI Clincal & Regulatory Affairs Team #1
- 전화번호: +821063465208
- 이메일: sy.choi@classys.com
연구 연락처 백업
- 이름: MOONHEE LEE
- 이메일: mhlee@classys.com
연구 장소
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Chengdu, 중국
- The Chengdu Second People's Hospital
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Chongqing, 중국
- The First Affiliated Hospital of Chongqing Medical University
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Hebei, 중국
- The First Hospital of Hebei Medical University
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Shanghai, 중국
- Huashan Hospital Affiliated to Fudan University
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
예
설명
Inclusion Criteria:
- Participants aged 18 to 65 years at the time of written informed consent.
- Participants with Fitzpatrick skin types II to V.
- Participants with facial atrophic acne scars and an ECCA score ≥60 as assessed by the investigator.
- Participants who are able to understand the purpose and procedures of the study, voluntarily agree to participate, and provide written informed consent.
Exclusion Criteria:
- Participants with a history of facial surgery or cosmetic surgical procedures, or those planning to undergo cosmetic surgical treatment during the study period, which in the investigator's judgment may increase treatment risk or affect efficacy evaluation, including any of the following:
- Participants with active or progressive skin diseases in the treatment area, or skin diseases associated with the Koebner phenomenon, such as eczema, psoriasis vulgaris, lichen planus, or vitiligo, which in the investigator's judgment may affect treatment or evaluation.
- Participants with open wounds, malignant or unspecified skin tumors, precancerous lesions, or viral, bacterial, or fungal infections in the treatment area, including herpes simplex, verruca vulgaris, verruca plana, cutaneous tuberculosis, or mycobacterial infections.
- Participants with scars, tattoos, piercings, excessive hair, or other conditions in the treatment area that, in the investigator's judgment, may interfere with treatment or evaluation.
- Participants with impaired skin barrier function in the treatment area that, in the investigator's judgment, may increase treatment risk or affect efficacy evaluation.
- Participants with a history of excessive sun exposure within 1 month prior to screening that, in the investigator's judgment, may increase treatment risk or affect efficacy evaluation.
- Participants with known hypersensitivity or allergy to lidocaine, other local anesthetics, or any device or medication components used in this study.
- Participants with severe hepatic or renal dysfunction, serious disease of other major organs, or uncontrolled diabetes mellitus.
- Participants with abnormal coagulation function during screening, use of medications affecting platelet or coagulation function, or platelet count below the lower limit of normal.
- Participants with active autoimmune disease or a history of autoimmune disease, including systemic lupus erythematosus, rheumatoid arthritis, scleroderma, or dermatomyositis.
- Participants with a history of keloid formation.
- Participants diagnosed with psychiatric disorders or active anxiety or depression that may impair the ability to understand or comply with study requirements.
- Participants with metallic implants such as cardiac pacemakers or implantable cardioverter-defibrillators.
- Participants planning pregnancy during the study period or unwilling to use medically acceptable contraception methods.
- Participants who are pregnant or breastfeeding.
- Participants who participated in another clinical trial involving a drug and/or medical device within 1 month prior to enrollment.
- Participants considered unsuitable for participation by the investigator for any other reason.
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: Investigational Device arm
Participants will receive treatment on acne scar areas using the investigational radiofrequency medical device according to the study protocol.
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The investigational radiofrequency medical device with the function deactivated will be applied to acne scar areas according to the study protocol.
The investigational radiofrequency medical device with the function activated will be applied to acne scar areas according to the study protocol.
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활성 비교기: Control Device arm
Participants will receive treatment on acne scar areas using the control device according to the study protocol.
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The control device will be applied to acne scar areas according to the study protocol.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Change in Échelle d'évaluation clinique des cicatrices d'acné(ECCA) Score From Baseline
기간: 12 weeks ±14 days after the final treatment
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Evaluated by blinded evaluators, Atrophic scar only ECCA score: 0(minimum)~180(maximum), Improvement = Baseline in ECCA Score - Follow-up in ECCA Score
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12 weeks ±14 days after the final treatment
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Change in Échelle d'évaluation cliniquedes cicatrices d'acné(ECCA) Score From Baseline
기간: before the second treatment, before the final treatment, 4 weeks after the final treatment, 12 weeks after the final treatment, 24 weeks after the final treatment
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Atrophic scar only ECCA: 0(minimum)~180(maximum), Improvement = Baseline in ECCA Score - Follow-up in ECCA Score
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before the second treatment, before the final treatment, 4 weeks after the final treatment, 12 weeks after the final treatment, 24 weeks after the final treatment
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Global Aesthetic Improvement Scale(GAIS) Score
기간: before the second treatment, before the final treatment, 4 weeks after the final treatment, 12 weeks after the final treatment, and 24 weeks after the final treatment
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Evaluated using a 5-point scale ranging from 0 (minimum) to 5 (maximum), with lower scores indicating better improvement.
(1=Very much improved, 2=Much improved, 3=Improved, 4=No change, 5=Worse)
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before the second treatment, before the final treatment, 4 weeks after the final treatment, 12 weeks after the final treatment, and 24 weeks after the final treatment
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Participant Satisfaction Assessment
기간: before the second treatment,(before the final treatment, 4 weeks after the final treatment, 12 weeks after the final treatment, 24 weeks after the final treatment
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evaluated using a subject satisfaction questionnaire completed by the subjects. (1=Very Dissatisfied, 2=Dissatisfied, 3=Neutral, 4=Satisfied, 5=Very Satisfied) |
before the second treatment,(before the final treatment, 4 weeks after the final treatment, 12 weeks after the final treatment, 24 weeks after the final treatment
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Pain Score Assessment
기간: Immediately following each treatment session at Week 0, Week 4, and Week 8
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assessed by study participants using the Numeric Rating Scale (NRS).
Score range: 0-10 (0 = No pain, 1-3 = Mild pain, 4-6 = Moderate pain, 7-10 = Severe pain)
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Immediately following each treatment session at Week 0, Week 4, and Week 8
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기타 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Safety Assessment
기간: Screening Period, Prior to the first/second/third procedure, Following the first/second/third procedure, 4 weeks after the last procedure, 12 weeks after the last procedure, 24 weeks after the last procedure
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Incidence and rate (%) of AEs and SAEs were evaluated.
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Screening Period, Prior to the first/second/third procedure, Following the first/second/third procedure, 4 weeks after the last procedure, 12 weeks after the last procedure, 24 weeks after the last procedure
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Safety Assessment
기간: Periprocedurally at the first, second, and third procedures
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Incidence and rate (%) of device deficiencies were evaluated.
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Periprocedurally at the first, second, and third procedures
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Body Temperature (°C)
기간: Screening; prior to and following the first, second, and third procedures; and at 4, 12, and 24 weeks after the last procedure.
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Clinically significant changes in body temperature will be assessed and analyzed according to the methods specified in the Statistical Analysis Plan (SAP).
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Screening; prior to and following the first, second, and third procedures; and at 4, 12, and 24 weeks after the last procedure.
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Pulse Rate(beats/minute)
기간: Screening period; prior to and following the first, second, and third procedures; 4 weeks after the last procedure; 12 weeks after the last procedure; and 24 weeks after the last procedure.
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Clinically significant changes in pulse rate will be assessed and analyzed according to the methods specified in the Statistical Analysis Plan (SAP).
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Screening period; prior to and following the first, second, and third procedures; 4 weeks after the last procedure; 12 weeks after the last procedure; and 24 weeks after the last procedure.
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Blood Pressure (mmHg)
기간: Screening period; prior to and following the first, second, and third procedures; 4 weeks after the last procedure; 12 weeks after the last procedure; and 24 weeks after the last procedure.
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Clinically significant changes in blood pressure will be assessed and analyzed according to the methods specified in the Statistical Analysis Plan (SAP).
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Screening period; prior to and following the first, second, and third procedures; 4 weeks after the last procedure; 12 weeks after the last procedure; and 24 weeks after the last procedure.
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
스폰서
수사관
- 수석 연구원: Zhong Lu, Huashan Hospital
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (추정된)
2026년 6월 1일
기본 완료 (추정된)
2027년 3월 1일
연구 완료 (추정된)
2027년 10월 1일
연구 등록 날짜
최초 제출
2026년 5월 11일
QC 기준을 충족하는 최초 제출
2026년 5월 29일
처음 게시됨 (실제)
2026년 6월 2일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2026년 6월 2일
QC 기준을 충족하는 마지막 업데이트 제출
2026년 5월 29일
마지막으로 확인됨
2026년 5월 1일
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
- CLA-QD-CCBH
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
미정
IPD 계획 설명
The sponsor has not yet determined whether individual participant data (IPD) will be shared.
Any future decision regarding IPD sharing will be made in accordance with applicable regulations, institutional policies, and participant confidentiality requirements.
약물 및 장치 정보, 연구 문서
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아니
미국에서 제조되어 미국에서 수출되는 제품
아니
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