Clinical Trials Directory

Trials / Completed

CompletedNCT07078851

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

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
20 (actual)
Sponsor
First Affiliated Hospital of Chongqing Medical University · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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

Interventions

TypeNameDescription
DEVICEFractional Picosecond Laser TreatmentCompound 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
DEVICEgold microneedle treatmentThe 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

Timeline

Start date
2023-09-01
Primary completion
2024-09-28
Completion
2024-09-28
First posted
2025-07-22
Last updated
2025-07-22

Locations

1 site across 1 country: China

Source: ClinicalTrials.gov record NCT07078851. Inclusion in this directory is not an endorsement.