Randomized, Double-Blinded, Sham-Controlled, Split-Hand Trial Evaluating the Safety and Efficacy of Triamcinolone Acetate Injection After Calcium Hydroxylapatite Volume Restoration of the Dorsal Hand


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Abstract

BACKGROUNDCalcium hydroxylapatite (CaHA) is currently the only FDA-approved soft-tissue filler indicated for augmentation of the dorsal hand. Although the treatment is generally safe and effective, adverse side effects such as swelling and edema postinjection are common and can sometimes be debilitating.OBJECTIVEIn this study, the authors explore the utility of triamcinolone acetate coinjection with CaHA to the dorsal hands to mitigate adverse effects and improve patient experience.PATIENTS AND METHODSAfter obtaining informed consent, 20 subjects were enrolled in this double-blind, randomized, split-hand, sham-controlled clinical trial. Subject hands were randomized to receive either CaHA with triamcinolone acetate or CaHA with sham saline coinjection. Follow-up evaluations were performed by a blinded investigator at Days 7, 14, 30, 90, 180, 270, and 360 and consisted of the validated Merz Hand Grading Scale and assessments of erythema, edema, modules, bruising, and skin atrophy. Subjects also kept a daily diary for the first 30 days postinjection documenting bruising, itching, pain, redness, swelling, difficulty in performing activities with hands, and sensory alteration in hands.RESULTSThere were no significant differences in treatment efficacy between the 2 groups. Post-treatment swelling was significantly reduced between Days 6 and 19 in the triamcinolone acetate coinjection group.CONCLUSIONThe addition of triamcinolone acetate coinjection with CaHA for dorsal hand augmentation did not negatively impact treatment efficacy but significantly reduced adverse side effects. This strategy represents a safe and effective way to improve patient experience and treatment tolerability.

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