Safety and Efficacy Evaluation of the Radiofrequency Therapeutic Device for the Treatment of Atrophic Acne Scars

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)

Study Overview

• Status: Not yet recruiting
• Conditions: Acne Scars; Acne Scarring; Acne Scar; Acne Scars - Atrophic
• Intervention / Treatment: Device: Investigational Device with the function deactivated; Device: Investigational Device with the function activated; Device: Control Device

• Study Type: Interventional
• Enrollment (Estimated): 252
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: SOYOUNG CHOI Clincal & Regulatory Affairs Team #1; Phone Number: +821063465208; Email: sy.choi@classys.com
• Study Contact Backup: Name: MOONHEE LEE; Email: mhlee@classys.com

Study Locations

• China
  • Chengdu, China
    • The Chengdu Second People's Hospital
  • Chongqing, China
    • The First Affiliated Hospital of Chongqing Medical University
  • Hebei, China
    • The First Hospital of Hebei Medical University
  • Shanghai, China
    • Huashan Hospital Affiliated to Fudan University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

1. Participants aged 18 to 65 years at the time of written informed consent.
2. Participants with Fitzpatrick skin types II to V.
3. Participants with facial atrophic acne scars and an ECCA score ≥60 as assessed by the investigator.
4. Participants who are able to understand the purpose and procedures of the study, voluntarily agree to participate, and provide written informed consent.

Exclusion Criteria:

1. 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:
2. 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.
3. 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.
4. 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.
5. Participants with impaired skin barrier function in the treatment area that, in the investigator's judgment, may increase treatment risk or affect efficacy evaluation.
6. 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.
7. Participants with known hypersensitivity or allergy to lidocaine, other local anesthetics, or any device or medication components used in this study.
8. Participants with severe hepatic or renal dysfunction, serious disease of other major organs, or uncontrolled diabetes mellitus.
9. Participants with abnormal coagulation function during screening, use of medications affecting platelet or coagulation function, or platelet count below the lower limit of normal.
10. Participants with active autoimmune disease or a history of autoimmune disease, including systemic lupus erythematosus, rheumatoid arthritis, scleroderma, or dermatomyositis.
11. Participants with a history of keloid formation.
12. Participants diagnosed with psychiatric disorders or active anxiety or depression that may impair the ability to understand or comply with study requirements.
13. Participants with metallic implants such as cardiac pacemakers or implantable cardioverter-defibrillators.
14. Participants planning pregnancy during the study period or unwilling to use medically acceptable contraception methods.
15. Participants who are pregnant or breastfeeding.
16. Participants who participated in another clinical trial involving a drug and/or medical device within 1 month prior to enrollment.
17. Participants considered unsuitable for participation by the investigator for any other reason.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Investigational Device arm; Participants will receive treatment on acne scar areas using the investigational radiofrequency medical device according to the study protocol.	Device: Investigational Device with the function deactivated; The investigational radiofrequency medical device with the function deactivated will be applied to acne scar areas according to the study protocol.; Device: Investigational Device with the function activated; The investigational radiofrequency medical device with the function activated will be applied to acne scar areas according to the study protocol.
Active Comparator: Control Device arm; Participants will receive treatment on acne scar areas using the control device according to the study protocol.	Device: Control Device; The control device will be applied to acne scar areas according to the study protocol.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Échelle d'évaluation clinique des cicatrices d'acné(ECCA) Score From Baseline	Evaluated by blinded evaluators, Atrophic scar only ECCA score: 0(minimum)~180(maximum), Improvement = Baseline in ECCA Score - Follow-up in ECCA Score	12 weeks ±14 days after the final treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Échelle d'évaluation cliniquedes cicatrices d'acné(ECCA) Score From Baseline	Atrophic scar only ECCA: 0(minimum)~180(maximum), Improvement = Baseline in ECCA Score - Follow-up in ECCA Score	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
Global Aesthetic Improvement Scale(GAIS) Score	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)	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
Participant Satisfaction Assessment	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
Pain Score Assessment	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)	Immediately following each treatment session at Week 0, Week 4, and Week 8

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety Assessment	Incidence and rate (%) of AEs and SAEs were evaluated.	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
Safety Assessment	Incidence and rate (%) of device deficiencies were evaluated.	Periprocedurally at the first, second, and third procedures
Body Temperature (°C)	Clinically significant changes in body temperature will be assessed and analyzed according to the methods specified in the Statistical Analysis Plan (SAP).	Screening; prior to and following the first, second, and third procedures; and at 4, 12, and 24 weeks after the last procedure.
Pulse Rate(beats/minute)	Clinically significant changes in pulse rate will be assessed and analyzed according to the methods specified in the Statistical Analysis Plan (SAP).	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.
Blood Pressure (mmHg)	Clinically significant changes in blood pressure will be assessed and analyzed according to the methods specified in the Statistical Analysis Plan (SAP).	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.

Collaborators and Investigators

• Sponsor: CLASSYS Inc.
• Investigators: Principal Investigator: Zhong Lu, Huashan Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): October 1, 2027

Study Registration Dates

• First Submitted: May 11, 2026
• First Submitted That Met QC Criteria: May 29, 2026
• First Posted (Actual): June 2, 2026

Study Record Updates

• Last Update Posted (Actual): June 2, 2026
• Last Update Submitted That Met QC Criteria: May 29, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: acne scar; atrophic acne scar; radiofreqency device; Radiofrequency Therapeutic Device
• Other Study ID Numbers: CLA-QD-CCBH

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No