Acne ScarsNCT07620769
Safety and Efficacy Evaluation of the Radiofrequency Therapeutic Device for the Treatment of Atrophic Acne Scars
A study testing Investigational Device with the function deactivated and Investigational Device with the function activated in people with Acne Scars and Acne Scars - Atrophic, run by CLASSYS Inc. at 4 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Acne Scars, Acne Scars - Atrophic, Acne Scar
- What is being tested?
- Investigational Device with the function deactivated and Investigational Device with the function activated
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 252 participants
- Where
- 4 sitesChina
- Study dates
- Jun 2026to Oct 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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:
- 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.
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- 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.
- Participants with abnormal coagulation function during screening, use of medications affecting platelet or coagulation function, or platelet count below the lower limit of normal.
- Participants with active autoimmune disease or a history of autoimmune disease, including systemic lupus erythematosus, rheumatoid arthritis, scleroderma, or dermatomyositis.
- Participants with a history of keloid formation.
- Participants diagnosed with psychiatric disorders or active anxiety or depression that may impair the ability to understand or comply with study requirements.
- Participants with metallic implants such as cardiac pacemakers or implantable cardioverter-defibrillators.
- Participants planning pregnancy during the study period or unwilling to use medically acceptable contraception methods.
- Participants who are pregnant or breastfeeding.
- Participants who participated in another clinical trial involving a drug and/or medical device within 1 month prior to enrollment.
- Participants considered unsuitable for participation by the investigator for any other reason.
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
MOONHEE LEE contact
China4 sites
The Chengdu Second People's Hospital
Chengdu
The First Affiliated Hospital of Chongqing Medical University
Chongqing
The First Hospital of Hebei Medical University
Hebei
Huashan Hospital Affiliated to Fudan University
Shanghai
About this study
Official title: A Prospective, Multicenter, Randomized, Parallel-Controlled, Blinded-Assessment, Non-Inferiority Clinical Trial to Evaluate the Safety and Effectiveness of a Radiofrequency Therapeutic Device for the Treatment of Atrophic Acne Scars
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.
Read more
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)
- Conditions
- Acne Scars, Acne Scars - Atrophic, Acne Scar, Acne Scarring
- Being tested
- Investigational Device with the function deactivated, Investigational Device with the function activated, Control Device
- Keywords
- acne scar, atrophic acne scar, radiofreqency device, Radiofrequency Therapeutic Device
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Investigational Device with the function deactivatedDevice
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 activatedDevice
The investigational radiofrequency medical device with the function activated will be applied to acne scar areas according to the study protocol.
Control DeviceDevice
The control device will be applied to acne scar areas according to the study protocol.
| Study group | Role | What they receive |
|---|---|---|
| Investigational Device arm | Experimental | Participants will receive treatment on acne scar areas using the investigational radiofrequency medical device according to the study protocol. Receives: Device: Investigational Device with the function deactivated; Device: Investigational Device with the function activated |
| Control Device arm | Active comparator | Participants will receive treatment on acne scar areas using the control device according to the study protocol. Receives: Device: Control Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 12 weeks ±14 days after the final treatment
Secondary outcomes (4)
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
Measured: 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)
Measured: 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)
Measured: 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)
Measured: Immediately following each treatment session at Week 0, Week 4, and Week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2026
- Study startJun 2026 (estimated)
- Primary completionMar 2027 (estimated)
- Study completionOct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acne ScarsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Device: Radiofrequency Therapeutic Device
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 252 participants (estimated)
Sponsor and investigators
- Lead sponsor
- CLASSYS Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Zhong Lu, Principal investigator, Huashan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07620769
- Sponsor's protocol ID
- CLA-QD-CCBH
- Status last verified
- May 2026
- First submitted
- 11 May 2026
- Last updated
- 2 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multicenter, Randomized, Parallel-Controlled, Blinded-Assessment, Non-Inferiority Clinical Trial to Evaluate the Safety and Effectiveness of a Radiofrequency Therapeutic Device for the Treatment of Atrophic Acne Scars
- ClinicalTrials.gov ID
- NCT07620769
- Acronym / sponsor ID
- CLA-QD-CCBH
- Conditions
- Acne Scars, Acne Scars - Atrophic, Acne Scar, Acne Scarring
- Keywords
- acne scar, atrophic acne scar, radiofreqency device, Radiofrequency Therapeutic Device
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 252 participants (estimated)
- Lead sponsor
- CLASSYS Inc.Industry (pharma, biotech, devices)
- Study start
- Jun 2026 (estimated)
- Primary completion
- Mar 2027 (estimated)
- Study completion
- Oct 2027 (estimated)
- First posted
- 2 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Device: Radiofrequency Therapeutic Device
| Arm | Type | Receives |
|---|---|---|
| Investigational Device arm | Experimental | Device: Investigational Device with the function deactivated, Device: Investigational Device with the function activatedParticipants will receive treatment on acne scar areas using the investigational radiofrequency medical device according to the study protocol. |
| Control Device arm | Active comparator | Device: Control DeviceParticipants will receive treatment on acne scar areas using the control device according to the study protocol. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (17 listed)
- 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:
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Investigational Device with the function deactivatedThe investigational radiofrequency medical device with the function deactivated will be applied to acne scar areas according to the study protocol. | Device | Investigational Device arm |
| Investigational Device with the function activatedThe investigational radiofrequency medical device with the function activated will be applied to acne scar areas according to the study protocol. | Device | Investigational Device arm |
| Control DeviceThe control device will be applied to acne scar areas according to the study protocol. | Device | Control Device arm |
Primary outcome
Change in Échelle d'évaluation clinique des cicatrices d'acné(ECCA) Score From Baseline
Time frame: 12 weeks ±14 days after the final treatment
Evaluated by blinded evaluators, Atrophic scar only ECCA score: 0(minimum)~180(maximum), Improvement = Baseline in ECCA Score - Follow-up in ECCA Score
4 secondary outcomes
Change in Échelle d'évaluation cliniquedes cicatrices d'acné(ECCA) Score From Baseline
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
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
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
Time frame: Immediately following each treatment session at Week 0, Week 4, and Week 8
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2026.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
MOONHEE LEE contact
Zhong Lu principal investigator
Huashan Hospital
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Investigational Device with the function deactivated and Investigational Device with the function activated in people with Acne Scars and Acne Scars - Atrophic, run by CLASSYS Inc. at 4 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 2 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact SOYOUNG CHOI Clincal & Regulatory Affairs Team #1 (+821063465208, sy.choi@classys.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Échelle d'évaluation clinique des cicatrices d'acné(ECCA) Score From Baseline (time frame: 12 weeks ±14 days after the final treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jun 2026.