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Safety and Efficacy Evaluation of the Radiofrequency Therapeutic Device for the Treatment of Atrophic Acne Scars
Sponsor: CLASSYS Inc.
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
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.
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.
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