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

NCT07620769 | Not Yet Recruiting

• 1 other identifier: CLA-QD-CCBH
• Study Type: interventional
• Target: 252
• Locations: 1 country
• Sites: 4

Brief Summary

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)

Conditions

Acne Scars; Acne Scars - Atrophic; Acne Scar; Acne Scarring

Keywords

acne scar; atrophic acne scar; radiofreqency device; Radiofrequency Therapeutic Device

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Change in Échelle d'évaluation cliniquedes cicatrices d'acné(ECCA) Score From Baseline

  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

  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

  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

  Immediately following each treatment session at Week 0, Week 4, and Week 8

Other Outcomes (5)

• Safety Assessment

  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

  Periprocedurally at the first, second, and third procedures

• Body Temperature (°C)

  Screening; prior to and following the first, second, and third procedures; and at 4, 12, and 24 weeks after the last procedure.

Study Arms (2)

Investigational Device arm

EXPERIMENTAL

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; Device: Investigational Device with the function activated

Control Device arm

ACTIVE COMPARATOR

Participants will receive treatment on acne scar areas using the control device according to the study protocol.

Device: Control Device

Interventions

Investigational Device with the function deactivated DEVICE

The investigational radiofrequency medical device with the function deactivated will be applied to acne scar areas according to the study protocol.

Investigational Device arm

Investigational Device with the function activated DEVICE

The investigational radiofrequency medical device with the function activated will be applied to acne scar areas according to the study protocol.

Investigational Device arm

Control Device DEVICE

The control device will be applied to acne scar areas according to the study protocol.

Control Device arm

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• CLASSYS Inc.: lead

Study Sites (4)

The Chengdu Second People's Hospital

Chengdu, China

Location

The First Affiliated Hospital of Chongqing Medical University

Chongqing, China

Location

The First Hospital of Hebei Medical University

Hebei, China

Location

Huashan Hospital Affiliated to Fudan University

Shanghai, China

Location

Study Officials

• Zhong Lu

  Huashan Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

SOYOUNG CHOI Clincal & Regulatory Affairs Team #1

CONTACT

+821063465208; sy.choi@classys.com

MOONHEE LEE

CONTACT

mhlee@classys.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Device: Radiofrequency Therapeutic Device

Study Record Dates

• First Submitted: May 11, 2026
• First Posted: June 2, 2026
• Study Start: June 1, 2026
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): October 1, 2027
• Last Updated: June 2, 2026

Record last verified: 2026-05

Locations

CN (4)