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Completed

NCT Number: NCT07078851

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The First Affiliated Hospital of Chongqing Medical University

Chongqing, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

  • 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.

Treatment and study plan

Fractional Picosecond Laser Treatment

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 treatment

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

Primary outcomes

  1. ECCA score

    Time frame: 0, 4, 8, 12, 16, 24 weeks

    Echelle d 'Evaluation Clinique des Cicatrices d 'acne

Sponsors and collaborators

Lead sponsor

First Affiliated Hospital of Chongqing Medical University

Other

Registry information

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Jul 22, 2025
Registry last updated
Jul 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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