Dissolving Triamcinolone-Embedded Microneedles for the Treatment of Keloids: A Single-Blinded Intra-Individual Controlled Clinical Trial

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.

Keywords: Keloids; Microneedles; Scars.

Fig. 1

a Dissolving triamcinolone-embedded hyaluronic acid microneedle patch (bottom). A holder (left) is used to affix the patch to a spring applicator (right). The latter is used so that the force delivering the microneedles into the skin is constant throughout the trial. b Close-up view of hyaluronic acid microneedles with triamcinolone acetonide embedded at the sharp ends

Fig. 2

Scanning photos with a three-dimensional camera of a microneedle-treated keloid (left) and a control keloid (right) in a subject with the two keloids in close proximity. Compared with baseline (a), the volume of the microneedle-treated keloid was significantly lower after 4 weeks of treatment (b)

Fig. 3

Representative clinical photos of a keloid at the umbilicus at baseline (a) and after 4 weeks of treatment with triamcinolone-embedded dissolving microneedles (b). Erythaema and volume of the keloid were reduced, associated with wrinkling on the skin surface and enlargement of the umbilical opening