Safety and Efficacy Evaluation of the Radiofrequency Therapeutic Device for the Treatment of Atrophic Acne Scars
29 maja 2026 zaktualizowane przez: 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)
Przegląd badań
Status
Jeszcze nie rekrutacja
Typ studiów
Interwencyjne
Zapisy (Szacowany)
252
Faza
- Nie dotyczy
Kontakty i lokalizacje
Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.
Kontakt w sprawie studiów
- Nazwa: SOYOUNG CHOI Clincal & Regulatory Affairs Team #1
- Numer telefonu: +821063465208
- E-mail: sy.choi@classys.com
Kopia zapasowa kontaktu do badania
- Nazwa: MOONHEE LEE
- E-mail: mhlee@classys.com
Lokalizacje studiów
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Chengdu, Chiny
- The Chengdu Second People's Hospital
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Chongqing, Chiny
- The First Affiliated Hospital of Chongqing Medical University
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Hebei, Chiny
- The First Hospital of Hebei Medical University
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Shanghai, Chiny
- Huashan Hospital Affiliated to Fudan University
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Kryteria uczestnictwa
Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.
Kryteria kwalifikacji
Wiek uprawniający do nauki
- Dorosły
- Starszy dorosły
Akceptuje zdrowych ochotników
Tak
Opis
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.
Plan studiów
Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Leczenie
- Przydział: Randomizowane
- Model interwencyjny: Przydział równoległy
- Maskowanie: Pojedynczy
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
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Eksperymentalny: 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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Aktywny komparator: 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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Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Change in Échelle d'évaluation clinique des cicatrices d'acné(ECCA) Score From Baseline
Ramy czasowe: 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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Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Change in Échelle d'évaluation cliniquedes cicatrices d'acné(ECCA) Score From Baseline
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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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Inne miary wyników
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Safety Assessment
Ramy czasowe: 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
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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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Współpracownicy i badacze
Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.
Sponsor
Śledczy
- Główny śledczy: Zhong Lu, Huashan Hospital
Daty zapisu na studia
Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.
Główne daty studiów
Rozpoczęcie studiów (Szacowany)
1 czerwca 2026
Zakończenie podstawowe (Szacowany)
1 marca 2027
Ukończenie studiów (Szacowany)
1 października 2027
Daty rejestracji na studia
Pierwszy przesłany
11 maja 2026
Pierwszy przesłany, który spełnia kryteria kontroli jakości
29 maja 2026
Pierwszy wysłany (Rzeczywisty)
2 czerwca 2026
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
2 czerwca 2026
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
29 maja 2026
Ostatnia weryfikacja
1 maja 2026
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Inne numery identyfikacyjne badania
- CLA-QD-CCBH
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
NIEZDECYDOWANY
Opis planu 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.
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Nie
Bada produkt urządzenia regulowany przez amerykańską FDA
Nie
produkt wyprodukowany i wyeksportowany z USA
Nie
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