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NOT YET RECRUITING
NCT07620769
NA

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

Sponsor: CLASSYS Inc.

View on ClinicalTrials.gov

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)

Official title: 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

Key Details

Gender

All

Age Range

18 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

252

Start Date

2026-06

Completion Date

2027-10

Last Updated

2026-06-02

Healthy Volunteers

Yes

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.

Locations (4)

The Chengdu Second People's Hospital

Chengdu, China

The First Affiliated Hospital of Chongqing Medical University

Chongqing, China

The First Hospital of Hebei Medical University

Hebei, China

Huashan Hospital Affiliated to Fudan University

Shanghai, China