Abstract
INTRODUCTION: Keloids are a prevalent chronic skin disorder with significant psychosocial morbidity. Intralesional corticosteroid injections are the first-line treatment but are painful and require repeated injections by medical professionals. Dissolving microneedles are a novel method of cutaneous drug delivery that induces minimal/no pain and can be self-administered. The objective of the study was to evaluate the efficacy and safety of triamcinolone-embedded dissolving microneedles in treatment of keloids. METHODS: This was a single-blind, intra-individual controlled two-phase clinical trial of 8-week duration each. Two keloids per subject were selected for (1) once-daily 2-min application with microneedles for 4 weeks, followed by no treatment for the next 4 weeks, or (2) non-intervention as control. Primary outcome was change in keloid volume as assessed by a high-resolution 3D scanner. RESULTS: There was significant reduction in keloid volume compared with controls after 4 weeks of treatment. This reduction was greater with a higher dosage of triamcinolone used. CONCLUSIONS: Once-daily application of dissolving triamcinolone-embedded microneedles significantly reduced the volume of keloids. The treatment was safe, can be self-administered and can serve as an alternative for patients unsuitable for conventional treatments. TRIAL REGISTRATION: Trial Registry: Health Science Authority (Singapore) Clinical Trials Register Registration number: 2015/00440.