Safety and Efficacy Evaluation of the Radiofrequency Therapeutic Device for the Treatment of Atrophic Acne Scars

ConditionsAcne Scars Acne Scars - Atrophic Acne Scar Acne Scarring

Trial statusNot yet recruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18-65

SponsorCLASSYS Inc.

About this trial

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)

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

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.
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.

Treatment groups

252 Participants

are divided into 2 treatment groups

Group A: Investigational Device armExperimental treatment 2 interventions

Group B: Control Device armActive comparator 1 intervention

Trial outcomes

Primary outcomes

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

Secondary outcomes

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

Other outcomes

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.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

CLASSYS Inc.

Lead sponsor

Source ClinicalTrials.gov

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