Comparative Study of Topical Pentoxifylline Versus Topical 5-Fluorouracil Combined With Microneedling and NB-UVB for Stable Vitiligo

Overview

This randomized, single-blinded clinical trial evaluates the efficacy and safety of topical pentoxifylline compared with topical 5-fluorouracil, both combined with microneedling and narrow-band ultraviolet B (NB-UVB) phototherapy, in patients with stable vitiligo. A total of 42 patients with stable vitiligo received six biweekly microneedling sessions over three months, with concomitant NB-UVB phototherapy twice weekly, followed by a three-month follow-up period. Each patient had three vitiliginous patches allocated to topical pentoxifylline with microneedling, topical 5-fluorouracil with microneedling, or microneedling alone.

Vitiligo is a chronic depigmenting disorder characterized by depigmented macules and patches resulting from selective destruction of melanocytes. Narrow-band ultraviolet B (NB-UVB) phototherapy is an established treatment for vitiligo, while microneedling may enhance treatment response by creating microchannels that improve topical drug delivery and stimulate a wound-healing response. This study was designed as a single-blinded comparative randomized trial involving 42 patients with stable vitiligo. Eligible patients had stable disease, defined as no new or progressive lesions for one year, and had received no treatment for at least three months. Patients with a history of keloidal or bleeding tendencies, anticoagulant therapy, pregnancy or breastfeeding, systemic or dermatological diseases, contraindications to phototherapy, photosensitive disorders, or a personal or family history of skin cancer were excluded. In each patient, three vitiliginous patches were randomly assigned to three treatment groups. Group A received microneedling combined with topical pentoxifylline (20 mg/mL), Group B received microneedling combined with topical 5-fluorouracil (5%), and Group C received microneedling alone. Microneedling was performed every two weeks for six sessions. All groups additionally received NB-UVB phototherapy twice weekly for three months, followed by NB-UVB phototherapy alone during the subsequent three-month follow-up period. Treatment response was assessed at baseline, at the end of treatment, and at three-month follow-up. Three blinded physicians evaluated repigmentation using the Physician Global Aesthetic Improvement Scale (GAIS). Quantitative assessment was also performed using a Visual Analog Scale (VAS) to measure percentage reduction in lesion size. Patient satisfaction and treatment-related adverse effects, including erythema, perilesional hyperpigmentation, and pain, were recorded. Participants were followed for an additional three months to assess durability of repigmentation, recurrence, and worsening of lesions. The study found that both topical pentoxifylline and topical 5-fluorouracil, when combined with microneedling and NB-UVB, produced greater improvement than microneedling alone. Pentoxifylline showed favorable response rates, particularly for lesions on the trunk, head, and neck, and was associated with fewer adverse effects. Perilesional hyperpigmentation was more frequent with topical 5-fluorouracil. The study was approved by the Ethics Committee under approval code 35642/8/22, and written informed consent was obtained from all participants after explanation of the study procedures, risks, and objectives.