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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)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Investigational Device arm | Experimental | Participants will receive treatment on acne scar areas using the investigational radiofrequency medical device according to the study protocol. |
|
| Control Device arm | Active Comparator | Participants will receive treatment on acne scar areas using the control device according to the study protocol. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Investigational Device with the function deactivated | Device | The investigational radiofrequency medical device with the function deactivated will be applied to acne scar areas according to the study protocol. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 12 weeks ±14 days after the final treatment |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Safety Assessment | Incidence and rate (%) of AEs and SAEs were evaluated. | 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 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| SOYOUNG CHOI Clincal & Regulatory Affairs Team #1 | Contact | +821063465208 | sy.choi@classys.com | |
| MOONHEE LEE | Contact | mhlee@classys.com |
| Name | Affiliation | Role |
|---|---|---|
| Zhong Lu | Huashan Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Chengdu Second People's Hospital | Chengdu | China | ||||
| The First Affiliated Hospital of Chongqing Medical University |
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.
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Device: Radiofrequency Therapeutic Device
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| Investigational Device with the function activated | Device | The investigational radiofrequency medical device with the function activated will be applied to acne scar areas according to the study protocol. |
|
| Control Device | Device | The control device will be applied to acne scar areas according to the study protocol. |
|
| 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) | 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) | 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) | Immediately following each treatment session at Week 0, Week 4, and Week 8 |
Incidence and rate (%) of device deficiencies were evaluated. |
| 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). | 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). | 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). | 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. |
| Chongqing |
| China |
| The First Hospital of Hebei Medical University | Hebei | China |
| Huashan Hospital Affiliated to Fudan University | Shanghai | China |