Evaluation of the Skin Irritation and Sensitization Potential of the Cussons Baby Sensicare Skin Range of Products in Healthy Volunteers

Abstract

Introduction: The Cussons Baby Sensicare Range is a newly developed set of products specially formulated for newborn, sensitive and eczema prone skin. As such, these products need to be tested to evaluate their skin irritation and sensitization potential before use. The products were evaluated with two separate tests. The first test was conducted in a single-center, within-subject comparison using assessor-blind, randomised human skin irritation patch test (48 hour/96 hour exposure) and conducted on healthy adults with sensitive, atopic skin. The second test was conducted in a single-center, controlled (sterile water), within subject using human repeat-insult patch tests (HRIPTs) and conducted on healthy female Indonesian and Asian adult female subjects, with sensitive skin. The sensitization potential of each product was determined from International Contact Dermatitis Research Group (ICDRG) scores at 30 minutes, 24 hours, 48 hours and 72 hours after patch removal. Skin irritation tests show that all products were significantly lower than the positive control sodium lauryl sulphate (SLS) (p < 0.05) but not significantly different to the negative control (sterile water) in terms of irritation scores at the respective time points. HRIPTs results show that Cussons Baby Sensicare Range was non-sensitizing. As such, it can be concluded that the Cussons Baby Sensicare Range tested is well tolerated on skin and has low skin irritation and sensitization potential. Thus, they can be considered hypoallergenic on sensitive skin and suitable for eczema prone skin.