A Prospective Randomized Trial of Microneedle Radiofrequency Combined with Low-dose Isotretinoin vs. Isotretinoin Alone for Acne Vulgaris Treatment

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Trial Design This randomized, prospective, evaluator-blinded clinical trial evaluating the efficacy and safety of micro-needle radiofrequency (MRF) combined with low-dose isotretinoin (10 mg/d, qd, for 8 weeks) in treating acne. Methods Patients were randomized 1:1 to receive either MRF plus isotretinoin or isotretinoin alone. MRF was administered once every 4 weeks (total 3 sessions). Primary outcome: the total ECCA scar improvement rate and the total skin lesion clearance rate at week 20. Evaluate efficacy trends and safety in two groups, and analyze skin microbiota changes via metagenomic next-generation sequencing (mNGS). Results Of 18 patients completing the trial, the combination group showed significantly higher total ECCA scar improvement rate and total skin lesion clearance rate at week 20 compared to controls. Acne lesions and scars improved significantly, with rolling scars > boxcar scars > ice-pick scars. Microbiota analysis revealed increased Cutibacterium acnes, C. avidum, and C. granulosum, and decreased Staphylococcus epidermidis and S. aureus, enhancing biodiversity. Metabolic pathway activity was significantly reduced in the treatment group compared to controls. Conclusions Combining MRF with low-dose isotretinoin is effective and safe, providing rapid and sustained improvement in acne. Enhanced efficacy may be due to skin microbiota modulation, offering insights into therapeutic mechanisms.(clinicaltrials.gov: NCT06378983)

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