Safety and Efficacy Evaluation of the Radiofrequency Therapeutic Device for the Treatment of Atro… (NCT07620769) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Safety and Efficacy Evaluation of the Radiofrequency Therapeutic Device for the Treatment of Atrophic Acne Scars
China252 participantsStarted 2026-06
Plain-language 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)
Who can participate
Age range
18 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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.
Exclusion criteria
. 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:
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in Échelle d'évaluation clinique des cicatrices d'acné(ECCA) Score From Baseline
Timeframe: 12 weeks ±14 days after the final treatment
. 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.