Comparing the Efficacy and Safety of Fractional Picosecond Laser and Gold Microneedle in the Treatment of Acne Scars

NCT ID: NCT07078851

Last Updated: 2025-07-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-09-01
• Study Completion Date: 2024-09-28

Brief Summary

The goal of this clinical trial is to compare a 755nm honeycomb picosecond laser versus a CO2 fractional laser for the treatment of atrophic acne Efficacy and safety of scarring.

The main questions it aims to answer are:

Effectiveness of 755nm Honeycomb Picosecond Laser and CO2 Fractional Laser in the Treatment of Atrophic Acne Scars

Effectiveness of scarring

Participants will:

the control group(receiving 10600nm CO₂ fractional laser[AFL]treatment)and the experimental group(receiving picosecond laser with honeycomb focusing lens array[P-DLA]treatment).Facial images were captured using the VISIA skin imaging system,and the red zone,UV spot,and brown spot scores were evaluated for all subjects before each treatment,and at 1 and 3 months post-treatment.

Conditions

Acne Scarring; Acne Scars

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Fractional Picosecond Laser Group

Group Type: EXPERIMENTAL

Fractional Picosecond Laser Treatment

Intervention Type: DEVICE

Compound lidocaine cream (Tongfang Pharmaceutical Group Co., Ltd., National Drug Approval Number: H20063466) was applied to the face. After 60 minutes, it was cleaned thoroughly in preparation for treatment. The subjects lay flat on the treatment bed, and the face was disinfected twice. Treatment was performed using the Picsure Focus Lens (Cynosure, USA, Registration Certificate Number: National Medical Device Import 20153242702) with the following parameters: 6mm spot size, focus filter, 755nm wavelength, energy of 6.0J/cm², and 2Hz frequency. The endpoint response was skin flushing and mild edema. Immediately after the operation, recombinant human epidermal growth factor (Kanghesu, 20000IU/4ml/vial, Shanghai Haohai Biological Technology Co., Ltd.) was applied externally, followed by wet compresses with saline gauze combined with cold spray for 30 minutes. The subjects were required to apply recombinant human epidermal growth factor to the entire facial skin twice a day (one vial each

gold microneedle group

Group Type: EXPERIMENTAL

gold microneedle treatment

Intervention Type: DEVICE

The face was topically anesthetized with compound lidocaine cream (Tongfang Pharmaceutical Group Co., Ltd., National Drug Approval No. H20063466). After 60 minutes, the cream was cleaned off thoroughly to prepare for treatment. The subject was positioned supine on the treatment bed, and the face was disinfected twice. Gold microneedle radiofrequency treatment was performed using the NDPRD00009-E 3DEEP Phased RF治疗仪 (Eedy Med, Israel). The gold microneedle handpiece was disinfected with 95% medical ethanol. Under sterile conditions, the microneedle tips were installed, and the treatment parameters were set as follows: Cheeks mode with Intensif method, microneedle length 0.8-2.0 mm (length \<1.5 mm for forehead, temporal region, and zygomatic bone prominences); RF output time 180 ms; RF power 6-16 W. The operator held the device vertically and applied it evenly across the treatment area in a grid pattern, ensuring gentle contact with the skin to avoid excessive pressure. Any untreated gaps

Interventions

Fractional Picosecond Laser Treatment

Compound lidocaine cream (Tongfang Pharmaceutical Group Co., Ltd., National Drug Approval Number: H20063466) was applied to the face. After 60 minutes, it was cleaned thoroughly in preparation for treatment. The subjects lay flat on the treatment bed, and the face was disinfected twice. Treatment was performed using the Picsure Focus Lens (Cynosure, USA, Registration Certificate Number: National Medical Device Import 20153242702) with the following parameters: 6mm spot size, focus filter, 755nm wavelength, energy of 6.0J/cm², and 2Hz frequency. The endpoint response was skin flushing and mild edema. Immediately after the operation, recombinant human epidermal growth factor (Kanghesu, 20000IU/4ml/vial, Shanghai Haohai Biological Technology Co., Ltd.) was applied externally, followed by wet compresses with saline gauze combined with cold spray for 30 minutes. The subjects were required to apply recombinant human epidermal growth factor to the entire facial skin twice a day (one vial each

Intervention Type: DEVICE

gold microneedle treatment

The face was topically anesthetized with compound lidocaine cream (Tongfang Pharmaceutical Group Co., Ltd., National Drug Approval No. H20063466). After 60 minutes, the cream was cleaned off thoroughly to prepare for treatment. The subject was positioned supine on the treatment bed, and the face was disinfected twice. Gold microneedle radiofrequency treatment was performed using the NDPRD00009-E 3DEEP Phased RF治疗仪 (Eedy Med, Israel). The gold microneedle handpiece was disinfected with 95% medical ethanol. Under sterile conditions, the microneedle tips were installed, and the treatment parameters were set as follows: Cheeks mode with Intensif method, microneedle length 0.8-2.0 mm (length \<1.5 mm for forehead, temporal region, and zygomatic bone prominences); RF output time 180 ms; RF power 6-16 W. The operator held the device vertically and applied it evenly across the treatment area in a grid pattern, ensuring gentle contact with the skin to avoid excessive pressure. Any untreated gaps

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

1. Patients diagnosed with symmetrical atrophic acne scars on both sides of the face by a dermatologist; 2）Age ≥ 18 years old; 3) Voluntarily participate and sign an informed consent form.

Exclusion Criteria

1. History of scar tissue in the past The person; 2) History of phototherapy such as laser and radiofrequency in the past 3 months; 3) History of photosensitivity or within the past 3 months Individuals who have taken photosensitive drugs; 4) Individuals allergic to lidocaine; 5) Individuals with coagulation dysfunction; 6) In the past 3 months History of oral corticosteroids and immunosuppressants; 7) Malignant tumor patients; 8) During pregnancy or lactation Women; 9) Individuals with local facial infections or injuries.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

First Affiliated Hospital of Chongqing Medical University

OTHER

Sponsor Role: lead

Responsible Party

Jin Chen

Chief Physician

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

The First Affiliated Hospital of Chongqing Medical University

Chongqing, , China

Countries

China

Other Identifiers

500103014

Identifier Type: -

Identifier Source: org_study_id