Comparison of SVF-gel Filling and CO2 Fractional Laser on Atrophic Acne Scar Treatment
Condition: Autologous Fat Graft Harvesting, SVF-gel Preparation and Filling; CO2 Fractional Laser Treatment by Using Acupulse Device
Study type: Interventional

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.
    

Intervention name(s): SVF-gel Filling and CO2 fractional laser
Intervention type(s): Device
Intervention description(s): 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.
Allocation: Randomized
Intervention model: Single Group Assignment
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.
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment