Autologous Fat Graft Harvesting, SVF-gel Preparation and Filling, CO2 Fractional Laser Treatment by Using Acupulse Device
Conditions
Brief 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.
Detailed description
This study was designed as a 24-week, prospective, randomized split-face protocol that compared clinical courses between two facial sides either receiving SVF-gel injection or CO2 fractional laser for acne scars. At the initial presentation, the evaluation of the severity of acne scar by Echelle d'Evaluation Clinique des Cicatrices d'acne (ECCA) scale (Table1), VISIA and Antera 3D analysis for all enrolled patients. Then, each facial side of every patient was randomly assigned into either SVF-gel injection or CO2 fractional laser treatment side. A random allocation sequence was created using computer-based random number generators to assign the treatment modality of each side. Randomization codes were secured in a safe until all data analyses were finished. Each patient was received SVF-gel injection for just one time on one half face, CO2 fractional laser treatment for two consecutive sessions at 8-week intervals on the other half face, with a follow-up visit at 16 weeks after the final CO2 fractional laser treatment. Evaluations of each treatment sessions were performed after 1 week, 2 months of every treatment. Two dermatologists evaluating the severities of acne scars were blinded to the assignment. At patients' each evaluation visit, photographic assessments by dermatologists, VISIA and Antera 3D analysis and patients' subjective assessments were conducted.
Interventions
DEVICESVF-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
Xijing Hospital
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
Two dermatologists evaluating the severity of acne scars were blinded to the assignment. At patients' each evaluation visit, photographic assessments by dermatologists, VISIA and Antera 3D analysis and patients' subjective assessments were conducted.
Intervention model description
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.
Eligibility
Sex/Gender
ALL
Age
16 Years to 35 Years
Healthy volunteers
No
Inclusion criteria
* Acne scar patients with severity of moderate to severe by ECCA scale evaluation. * All the subjects were not allowed to use any systemic, topical, or light-based acne scar treatment during the course of this study.
Exclusion criteria
* pregnancy, mental illness. * Intake of oral isotretinoin within 3 months * Application of the other chemical peeling and light-based treatments within 8 weeks
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| ECCA scale score | 3 Month after the second CO2 Fractional Laser treatment | ECCA scale score of each face before and after the treatment of SVF-gel filling and CO2 Fractional Laser |
Countries
China
Outcome results
None listed