Abstract
BACKGROUND: Adipose extracellular matrix/stromal vascular fraction gel (ECM/SVF-gel) contains adipose-derived stem cells, extracellular matrix, and other cell components, and possesses the ability to promote collagen production and serve as a filling agent. AIM: To assess the efficacy and safety of ECM/SVF-gel injection for the treatment of acne scars, compared to CO(2) fractional laser (CO(2)FL). METHODS: We performed an open-label, investigator-initiated, assessor-blinded, split-face trial in Xijing Hospital, China, between July 11, 2020, and December 30, 2022. Patients exhibiting moderate to severe acne scars were randomly assigned to a single ECM/SVF-gel injection on one half of the face or two sessions of CO(2)FL treatments on the other half. The primary outcome was the change in total Echelle d'Evaluation Clinique des Cicatrices d'acne (ECCA) score from baseline to 24-week follow-up. Secondary outcomes included the changes in the volume of scars assessed by the Antera 3D software. RESULTS: A total of 11 participants were enrolled, and 10 completed the follow-up. The mean age of patients was 27.5 ± 4.2, 7 female and four male, seven with Fitzpatrick skin Type III and four with Type IV. At 24weeks, the mean change in ECCA score was -60.25 on the side of ECM/SVF-gel injection and - 43.25 on the side of CO(2)FL treatment (difference:-17.00 [95% CI: -24.56 to -9.44], p < 0.001). Antera 3D photography analysis showed that the mean change in scar volume was -33.17% on ECM/SVF-gel injection and -19.69% on CO(2)FL (difference: -13.48% [95% CI:-22.16% to -4.79%], p = 0.004). CONCLUSIONS: ECM/SVF-gel injection is an effective and safe approach in the treatment of acne scars. TRIAL REGISTRATION: ClinicalTrials.gov number: NCT06116162.