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Subject Area

Dermatology

Article Type

Original Study

Abstract

Aim: This study aimed to compare the efficacy and safety of topical 5% 5-Fluorouracil (5-FU) with Needling versus 100% Trichloroacetic acid (TCA) with Needling versus Needling Alone in treatment of multiple warts.

Methods: This study included a total of 60 patients clinically diagnosed with multiple warts, who were randomly allocated (computer-generated simple randomisation, 1:1:1, concealed in sequentially numbered opaque sealed envelopes) into three equal groups (n=20 per group). The first group received 100% TCA with Needling; the second group received topical 5% 5-FU combined with Needling; the third group underwent Needling alone. The study was single-blinded at the level of the outcome assessor (an independent dermatologist not involved in treatment performed all clinical assessments) and the statistician; patients and treating physicians could not be blinded because of the visible nature of the interventions. The sample size (n=20 per group) was calculated a priori using G*Power 3.1.9.4 (effect size 0.737, two-tailed α=0.05, power=80%), based on Basavarajappa et al. (2021). Patients were followed up at 4, 8 and 12 weeks. Outcome assessment comprised wart size and number, standardised clinical photography, pain on an 11-point numerical rating scale, patient satisfaction, and adverse events.[REV1]

Results: The three groups showed no significant differences in wart number or size after treatment. Complete resolution occurred in 85% of the TCA + Needling group, 65% of the 5‑Fluorouracil + Needling group, and 60% of the Needling‑alone group. Pain levels were lowest with TCA + Needling and highest with Needling alone, showing a significant difference. Patient satisfaction was highest in the TCA + Needling group (95%) and lowest in the Needling‑alone group, where 30% of patients were dissatisfied.

Conclusion: Needling is an effective method for the treatment of multiple cutaneous warts. The between-group difference in complete response rate did not reach statistical significance (p=0.300). while the statistical analysis strictly yielded a non-significant result (p = 0.300), the 25-percentage-point difference in complete response rates between the TCA + Needling group (85%) and Needling alone (60%) represents a clinically meaningful trend, the lack of statistical significance is likely due to the limited power of our small sample size (n = 20 per group).However, both TCA + Needling and 5-FU + Needling were associated with significantly lower procedural pain (p

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Creative Commons Attribution 4.0 International License
This work is licensed under a Creative Commons Attribution 4.0 International License.

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