An interventional study of Investigational Device with the function deactivated and Investigational Device with the function activated in Acne Scars, Acne Scars - Atrophic and Acne Scar, sponsored by CLASSYS Inc.. Not yet recruiting at 4 sites in China. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-06-02.
Sponsored by CLASSYS Inc. · Not applicable, Interventional, and Treatment
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)
CLASSYS Inc. is the lead sponsor of 6 studies on the registry; 3 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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
Participants will receive treatment on acne scar areas using the control device according to the study protocol.
Device: Control Device
The investigational radiofrequency medical device with the function deactivated will be applied to acne scar areas according to the study protocol.
The investigational radiofrequency medical device with the function activated will be applied to acne scar areas according to the study protocol.
The control device will be applied to acne scar areas according to the study protocol.
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
Time frame: 12 weeks ±14 days after the final treatment
Change in Échelle d'évaluation cliniquedes cicatrices d'acné(ECCA) Score From Baseline
Atrophic scar only ECCA: 0(minimum)\~180(maximum), Improvement = Baseline in ECCA Score - Follow-up in ECCA Score
Time frame: 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
Evaluated using a 5-point scale ranging from 0 (minimum) to 5 (maximum), with lower scores indicating better improvement. (1=Very much improved, 2=Much improved, 3=Improved, 4=No change, 5=Worse)
Time frame: 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
evaluated using a subject satisfaction questionnaire completed by the subjects. (1=Very Dissatisfied, 2=Dissatisfied, 3=Neutral, 4=Satisfied, 5=Very Satisfied)
Time frame: 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
assessed by study participants using the Numeric Rating Scale (NRS). Score range: 0-10 (0 = No pain, 1-3 = Mild pain, 4-6 = Moderate pain, 7-10 = Severe pain)
Time frame: Immediately following each treatment session at Week 0, Week 4, and Week 8
Safety Assessment
Incidence and rate (%) of AEs and SAEs were evaluated.
Time frame: 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
Incidence and rate (%) of device deficiencies were evaluated.
Time frame: Periprocedurally at the first, second, and third procedures
Body Temperature (°C)
Clinically significant changes in body temperature will be assessed and analyzed according to the methods specified in the Statistical Analysis Plan (SAP).
Time frame: Screening; prior to and following the first, second, and third procedures; and at 4, 12, and 24 weeks after the last procedure.
Pulse Rate(beats/minute)
Clinically significant changes in pulse rate will be assessed and analyzed according to the methods specified in the Statistical Analysis Plan (SAP).
Time frame: Screening period; prior to and following the first, second, and third procedures; 4 weeks after the last procedure; 12 weeks after the last procedure; and 24 weeks after the last procedure.
Blood Pressure (mmHg)
Clinically significant changes in blood pressure will be assessed and analyzed according to the methods specified in the Statistical Analysis Plan (SAP).
Time frame: Screening period; prior to and following the first, second, and third procedures; 4 weeks after the last procedure; 12 weeks after the last procedure; and 24 weeks after the last procedure.
Plan to share: Undecided — The sponsor has not yet determined whether individual participant data (IPD) will be shared. Any future decision regarding IPD sharing will be made in accordance with applicable regulations, institutional policies, and participant confidentiality requirements.
No publications or documents are linked to this record.
This study is not yet recruiting, as verified in May 2026. You cannot join it, but the record below documents what was studied.
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CLASSYS Inc.