Efficacy of a triamcinolone acetonide-loaded dissolving microneedle patch for the treatment of hypertrophic scars and keloids: a randomized, double-blinded, placebo-controlled split-scar study.

Abstract

The treatment of hypertrophic scars (HTSs) and keloids remains a challenge. Intralesional triamcinolone acetonide (TAC) is the mainstay treatment for these conditions. Despite its efficacy, TAC has several adverse side effects, including telangiectasias, skin atrophy, pigmentary changes, and skin necrosis. Dissolving microneedles (DMN) use the poke-and-release method to create microchannels that enhance drug delivery to the target tissue in the dermis, without causing pain and with a decreased risk of transmission of blood-borne diseases. To evaluate and compare the efficacy of a TAC-DMN versus a drug-free DMN patch for the treatment of HTSs and keloids, 20 patients (10 with HTSs and 10 with keloids) received a split-scar treatment: one half of the scar length was treated with TAC-DMNs and the other half was treated with drug-free DMN for three sessions at 14-day intervals. Efficacy was assessed by measuring the scar volume through a multispectral imaging system and using the Patient and Observer Scar Assessment Scale (POSAS). The HTSs treated with TAC-DMNs showed a significant reduction in the mean scar volume 2weeks after the second treatment and 1month after the third treatment (p = 0.028 and 0.020, respectively), while the HTSs treated with drug-free DMNs showed no significant reduction in the scar volume. Both sides of the keloids showed no significant reduction in mean scar volume. Using the POSAS, significant improvement in the appearance of both halves of the HTSs was observed 1month after the treatments. A significant improvement (evaluated by POSAS) was also observed in the keloids treated with TAC-DMNs 2weeks after the second treatment and 1month after the third treatment. No significant improvement was observed from the patients' perspective as evaluated by POSAS in the keloids treated with drug-free DMNs. However, no significant difference was observed between the treatment and control halves. TAC-DMN is an effective treatment for HTSs. Increasing the dosage and duration of keloid scar treatment is required in future studies to determine whether it would result in a significant therapeutic outcome. This trial is registered in the Thai Clinical Trials Registry (TCTR20220318004; date of registration, March 17, 2022).