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

Abstract

Idiopathic guttate hypomelanosis (IGH) is a common skin disorder with no standard treatment. Assess the efficacy and safety of 5-fluorouracil (5FU) compared with saline, delivered using a tattoo machine, to repigment IGH lesions. 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. 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. 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.