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

NCT07620769 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 252

Last updated 2026-06-02

No results posted yet for this study

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

Interventions

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.

DEVICE

Control Device

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

Sponsors & Collaborators

  • CLASSYS Inc.

    lead INDUSTRY

Principal Investigators

  • Zhong Lu · Huashan Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-06-30
Primary Completion
2027-03-31
Completion
2027-10-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07620769 on ClinicalTrials.gov