Effectiveness of nanofat in treatment-refractory penile lichen sclerosus: results from a pilot retrospective single-center case series.

Background: Penile lichen sclerosus (PLS) is a chronic inflammatory skin disorder that may lead to progressive architectural distortion of male genitalia, with a dramatic impact on quality of life and a high unmet therapeutic need. In keeping with vulvar disease, nanofat grafting could represent a viable option in this setting.

Methods: Patients aged 18 years or above with biopsy-proven, medical and/or surgical treatment-resistant PLS were offered nanofat and were evaluated at baseline, 1 and 24 months.

Results: Fourteen male patients with a median age of 46 years (interquartile range [IQR]: 37.25-51.5) were included. Median modified Investigator Global Assessment (mIGA) scores changed from 18 (IQR: 14.75-22.75) at the baseline, to 15.5 (IQR: 13-20.25) at 1 month (P=0.002), to 14 (IQR: 8-17) at 24 months (P=0.001). mIGA subscores for erythema improved significantly after just one month (P=0.002) and the improvement was maintained throughout the 24 months of follow-up (P=0.001). At 24 months, a statistically significant reduction relative to the baseline was demonstrated also for itch (P=0.014), burning sensation (P=0.02) and dyspareunia (P=0.02). Median Patient Global Impression of Change at 24 months was 6 (IQR: 4.75-6.25) ("much improved"). No adverse effects or complications were recorded.

Conclusions: Nanofat grafting not only seems to improve genital tissue quality, but appears to act also on the inflammatory component of the disease. Further research will be needed to validate and optimize this approach for PLS.