CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 18 enrolled
Drug / intervention
SVF-gel Filling and CO2 fractional laserdevice
Likely dose
Not stated in record
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Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT06116162
NCT06116162N/ACompleted

Department of Dermatology of Xijing Hospital of Air Force Medicial University

Xijing Hospital·interventional·Posted Nov 3, 2023·Updated Nov 3, 2023

In Brief

A clinical study evaluating SVF-gel Filling and CO2 fractional laser for Autologous Fat Graft Harvesting, SVF-gel Preparation and Filling and CO2 Fractional Laser Treatment by Using Acupulse Device. Completed, enrolled 18 participants across 2 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesChina
Collaborators--

Timeline

N/ACompletedFinished
202120222023202420252026
First PostedNov 3, 2023
Enrollment StartJan 20, 2021
Primary CompletionJul 20, 2022
Study CompletionJan 20, 2023
TodayJul 2, 2026
Enrollment to primary: 1.5 yearsPosted 2.7 years ago

Interventions

SVF-gel Filling and CO2 fractional laserdevice

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.