Copaiba Oleoresin-Based Hydrogels for Skin Tear Treatment in Elderly Patients with Multiple Comorbidities: A Randomized, Controlled Clinical Trial

Skin tears are common acute wounds in older adults and are associated with morbidity, reduced quality of life, and increased healthcare burden. This randomized clinical trial evaluated two copaiba oleoresin polymeric hydrogels, CopaibaPolyHy-2 (2%) and Copai-baPolyHy-10 (10%), compared with a control hydrogel without active ingredient. A total of 120 participants were randomized equally among the three groups. Complete wound healing occurred in 70.0% of participants receiving CopaibaPolyHy-2, 72.5% receiving CopaibaPolyHy-10, and 67.5% receiving control treatment. No statistically significant dif-ferences were observed in complete healing rates for CopaibaPolyHy-2 versus control (RR 1.037; 95% CI 0.80–1.44) or CopaibaPolyHy-10 versus control (RR 1.070; 95% CI 0.81–1.43). Median healing times were 9, 13, and 10 days, respectively (p = 0.1472). Wound area reduction rates were 0.245, 0.160, and 0.200 cm²/day, respectively, with no significant be-tween-group difference (p = 0.6404). Although both copaiba formulations showed numer-ically favorable healing proportions, neither demonstrated superiority over the control hydrogel. These findings indicate that copaiba-based hydrogels were not associated with clinically or statistically significant improvements in skin tear healing in this population. Further studies should investigate optimized formulations, dosing strategies, and patient subgroups that may derive greater benefit. Larger multicenter trials may clarify potential clinical effects and therapeutic applicability.