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)
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
252
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.
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
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
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