Pain Assessment Study: Comparison of Three Liquid Skin Protectants

Introduction: Skin breakdown is a significant cause of financial burden across the healthcare spectrum.¹ Many solvent-based skin protectant solutions exist to combat this burden; however, commonly used solvents may cause irritation and inflammation.^2-4 The purpose of this study was to assess pain caused by a solvent-free cyanoacrylate protectant (product A) compared to no-sting polymer films (Product B and Product C).

Methods: A controlled, randomized, single blind, IRB approved exposure study was conducted.  Tape stripping of demarcated forearm surface was performed on twenty-six subjects. Positive and negative controls and the three test articles were applied at 15 minute intervals. Pain levels were recorded on a visual analog scale 0, 5, and, 15 minutes following application. A repeat insult patch test was also conducted on 51 subjects using Product A, which was graded 24 and 48 hours after patch removal.

Results: The positive control yielded significantly higher pain ratings than all products and the negative control. Pain levels of Product A, Product B and Product C did not vary significantly from the negative control. Product B caused significantly less pain than Product A. The repeat insult patch test yielded no dermal reaction for any subject at any point.

Conclusion: This twofold trial examined comparative pain levels caused by competing classes of protectants.  The findings of this study indicate that Product A performed similarly to Product C, a “no-sting” product.