Efficacy and Safety of 5-Fluorouracil Tattooing to Repigment Idiopathic Guttate Hypomelanosis: A Split-Body Randomized Trial

Abstract

BACKGROUD Idiopathic guttate hypomelanosis (IGH) is a common skin disorder with no standard treatment. OBJECTIVE Assess the efficacy and safety of 5-fluorouracil (5FU) compared with saline, delivered using a tattoo machine, to repigment IGH lesions. METHODS This split-body randomized single-blinded trial recruited adults with symmetrical IGH lesions. A tattoo machine was used to deliver 5FU in IGH lesions of 1 limb and saline in the contralateral limb. Outcomes were the number of achromic lesions 30 days after treatment compared with baseline, patient satisfaction, and local or systemic adverse events. RESULTS Twenty-nine patients (28 women) were included. The median number of achromic lesions decreased significantly in 5FU-treated limbs (baseline: 32, interquartile range (IQR) 23–37 × post-treatment: 12, IQR 6–18, p = .000003) and saline-treated limbs (baseline: 31, IQR 24–43 × post-treatment: 21, IQR 16–31, p = .000006), but reduction was significantly more pronounced in 5FU-treated limbs (p = .00003). All participants were satisfied or very satisfied with results on 5FU-treated limbs. There were no adverse events. CONCLUSION 5-fluorouracil delivery using a tattoo machine was more effective than saline to repigment IGH lesions, with high patient satisfaction and no adverse events. Clinicaltrials.gov: NCT02904564.