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Comparison of SVF-gel Filling and CO2 Fractional Laser on Atrophic Acne Scar Treatment

NCT06116162 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2023-11-03

No results posted yet for this study

Summary

Background Adipose extracellular matrix/stromal vascular fraction gel（SVF-gel）, which contains adipose-derived stem cells, endothelial cells, smooth muscle cells, pericytes, and other cell components.

Objective To determine the efficacy and safety of SVF-gel for treating acne scars and to compare the results with CO2 fractional laser.

Methods Seventeen patients with moderate to severe acne scars were treated with SVF-gel filling and CO2 fractional laser through a 24-week, randomized split-face study. One randomly assigned half side of each patient's received one SVF-gel filling treatment and the other side by two CO2 fractional laser treatment once one months. Clinical improvement was assessed by two blinded investigators with Echelle d'Evaluation Clinique des Cicatrices d'acne (ECCA) scale, VISIA and Antaro-3D detection.

Conditions

  • Autologous Fat Graft Harvesting, SVF-gel Preparation and Filling
  • CO2 Fractional Laser Treatment by Using Acupulse Device

Interventions

DEVICE

SVF-gel Filling and CO2 fractional laser

SVF-gel preparation and filling:The autologous fat graft was harvested from the lower abdomen or inner thigh of all subjects. Then the lipoaspirate was centrifuged at 1200g for 3 minutes to obtain Coleman fat in the middle layer. The Coleman fat was then transferred between two syringes until the Coleman fat converted into a uniform emulsion, and then processed by centrifugation at 2000g for 3 min. Finally, the remaining substance under the oil layer was SVF gel. We used a 22G sharp-tip injector to inject the SVF-gel into the dermis of acne scars, and the injected materials were diffusely distributed. CO2 fractional laser treatment: After local anesthesia, Acupulse device (LUMENIS, US) was used to perform CO2 fractional laser. The laser was operated in DeepFX mode under the parameters of 20-25 MJ energy intensity, 5% coverage. Superficial mode under the parameters of 80-120 MJ energy intensity, 40-60% coverage.

Sponsors & Collaborators

  • Xijing Hospital

    lead OTHER

Principal Investigators

  • Gang Wang, Ph.D. · Xijing Hospital of Air Force University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
SINGLE_GROUP

Eligibility

Min Age
16 Years
Max Age
35 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-01-20
Primary Completion
2022-07-20
Completion
2023-01-20

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06116162 on ClinicalTrials.gov