Safety and Efficacy Evaluation of the Radiofrequency Therapeutic Device for the Treatment of Atrophic Acne Scars
29 мая 2026 г. обновлено: 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)
Обзор исследования
Статус
Еще не набирают
Тип исследования
Интервенционный
Регистрация (Оцененный)
252
Фаза
- Непригодный
Контакты и местонахождение
В этом разделе приведены контактные данные лиц, проводящих исследование, и информация о том, где проводится это исследование.
Контакты исследования
- Имя: SOYOUNG CHOI Clincal & Regulatory Affairs Team #1
- Номер телефона: +821063465208
- Электронная почта: sy.choi@classys.com
Учебное резервное копирование контактов
- Имя: MOONHEE LEE
- Электронная почта: mhlee@classys.com
Места учебы
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Chengdu, Китай
- The Chengdu Second People's Hospital
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Chongqing, Китай
- The First Affiliated Hospital of Chongqing Medical University
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Hebei, Китай
- The First Hospital of Hebei Medical University
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Shanghai, Китай
- Huashan Hospital Affiliated to Fudan University
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Критерии участия
Исследователи ищут людей, которые соответствуют определенному описанию, называемому критериям приемлемости. Некоторыми примерами этих критериев являются общее состояние здоровья человека или предшествующее лечение.
Критерии приемлемости
Возраст, подходящий для обучения
- Взрослый
- Пожилой взрослый
Принимает здоровых добровольцев
Да
Описание
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.
Учебный план
В этом разделе представлена подробная информация о плане исследования, в том числе о том, как планируется исследование и что оно измеряет.
Как устроено исследование?
Детали дизайна
- Основная цель: Уход
- Распределение: Рандомизированный
- Интервенционная модель: Параллельное назначение
- Маскировка: Одинокий
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
|---|---|
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Экспериментальный: 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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Активный компаратор: 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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Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
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Change in Échelle d'évaluation clinique des cicatrices d'acné(ECCA) Score From Baseline
Временное ограничение: 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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Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
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Change in Échelle d'évaluation cliniquedes cicatrices d'acné(ECCA) Score From Baseline
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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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Другие показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
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Safety Assessment
Временное ограничение: 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
Временное ограничение: 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)
Временное ограничение: 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)
Временное ограничение: 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)
Временное ограничение: 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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Соавторы и исследователи
Здесь вы найдете людей и организации, участвующие в этом исследовании.
Спонсор
Следователи
- Главный следователь: Zhong Lu, Huashan Hospital
Даты записи исследования
Эти даты отслеживают ход отправки отчетов об исследованиях и сводных результатов на сайт ClinicalTrials.gov. Записи исследований и сообщаемые результаты проверяются Национальной медицинской библиотекой (NLM), чтобы убедиться, что они соответствуют определенным стандартам контроля качества, прежде чем публиковать их на общедоступном веб-сайте.
Изучение основных дат
Начало исследования (Оцененный)
1 июня 2026 г.
Первичное завершение (Оцененный)
1 марта 2027 г.
Завершение исследования (Оцененный)
1 октября 2027 г.
Даты регистрации исследования
Первый отправленный
11 мая 2026 г.
Впервые представлено, что соответствует критериям контроля качества
29 мая 2026 г.
Первый опубликованный (Действительный)
2 июня 2026 г.
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
2 июня 2026 г.
Последнее отправленное обновление, отвечающее критериям контроля качества
29 мая 2026 г.
Последняя проверка
1 мая 2026 г.
Дополнительная информация
Термины, связанные с этим исследованием
Ключевые слова
Другие идентификационные номера исследования
- CLA-QD-CCBH
Планирование данных отдельных участников (IPD)
Планируете делиться данными об отдельных участниках (IPD)?
НЕ РЕШЕНО
Описание плана IPD
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.
Информация о лекарствах и устройствах, исследовательские документы
Изучает лекарственный продукт, регулируемый FDA США.
Нет
Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.
Нет
продукт, произведенный в США и экспортированный из США.
Нет
Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .