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

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: At week 20, total skin lesion clearance rate exceeds 80%, and total ECCA acne scar score reduces by ≥10 points from baseline. Evaluate efficacy trends and safety in two groups, and analyze skin microbiota changes via metagenomic next-generation sequencing (mNGS).
Results
Among the 18 patients completing the study (9 per group), the treatment group showed significantly superior efficacy compared to the control group. At week 20, the skin lesion clearance rate in the treatment group reached 93.02%, with a 35 point reduction in total ECCA scar score. Microbiota analysis revealed increased biodiversity in both groups post-treatment, with the treatment group showing significantly reduced metabolic pathways compared to the control group.
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)