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Clinical Research
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A clinical study in healthy subjects comparing two trypsin, balsam of peru, and castor oil (TBC) formulations Mark W. Trumbore, PhD, Collegium Pharmaceutical, Cumberland, RI All TBC wound care products contain the same three active ingredients, trypsin, balsam peru and castor oil (TBC) at identical concentrations. These products improve healing in part by forming a protective, occlusive barrier preventing wound desiccation. Although the active ingredients of all TBC products are the same, the products can be differentiated by physical properties such as viscosity. These differences can influence the therapeutic efficacy of the various formulations. A clinical study was completed to assess the ability of two different TBC formulations to create an occlusive barrier at a wound site maintaining moisture to facilitate the healing process. The study was a single blind, crossover design that included 10 healthy subjects. It compared each formulation's ability to form an occlusive barrier following stratum corneum disruption as measured by transepidermal water loss (TEWL). TEWL of intact, abraded and treated skin was measured using a TewameterTM 300. The study design featured a paired comparison and was completed over a three day period. The statistical significance of the observed differences between treatments was examined using a Student's T-test. . .Two TBC formulations were examined. Both formulations produced a statistically significant 4-fold reduction in the TEWL of damaged skin (P-values < 0.001). Both treatments formed barriers more occlusive than that of untreated intact skin (P-values < 0.001). There was no statistically significant difference in the magnitude of TEWL reduction between either TBC formulation (P value 0.54). Neither treatment resulted in any reported adverse events The results indicate that the reduction in TEWL was statistically equivalent for both products. The results presented here demonstrate that although there were significant differences in the viscosity of the formulations this difference had no significant impact upon their ability to form a barrier to TEWL. These results suggest that both products would be effective in preventing premature wound desiccation. |
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