P0330 - HPA lanolin and its ability to protect the nipple when breastfeeding: Evidence from a novel clinical model of breastfeeding

Introduction: The causes of nipple trauma during breastfeeding are complex and varied, and it is difficult to generate conclusive data on efficacy of any treatment due to confounding factors inherent in the study population. We present here a novel clinical (forearm) model which simulates the repeat insult, moisture challenges and friction of the breastfeeding infant in a reproducible and clinically relevant way. The model was used to demonstrate the potential for HPA Lanolin to protect skin and to help skin recover from repeated barrier insult.

Methods: Stratum corneum of the forearm (n=30) was experimentally compromised by repeated stripping with adhesive tape. In addition, repeated surfactant challenges were included to simulate moisture challenges of a breastfeeding infant. Clinical (erythema & scaling) and instrumental assessments (Chromameter, Corneometer & Tewameter) were conducted at the test sites during the study. Assessments were carried out at Day -7, Day 0 (before and after skin damage), Days 1-4 and Day 7.

Results: The skin challenge methodology applied here resulted in a reliable and sustained level of barrier damage. Erythema, TEWL and moisturization were all impacted significantly by the damage model. Application of Lanolin prior to skin damage led to an increase in measured moisturization, compared to the untreated control site, even where there was no significant skin dryness. Moisturisation levels were reduced immediately after induction of barrier damage, as expected. However, the site pre-treated with lanolin remained numerically higher than the other sites. This difference was statistically significant. Additionally, use of the HPA Lanolin significantly reduced the degree of barrier damage induced in the model, based on TEWL measurements, demonstrating that regular use of the lanolin containing product significantly protected the skin barrier from the repeat insults.

Conclusions: We describe here a reproducible and robust model that mimics the damage to the skin of the breast experienced by breastfeeding nursing mothers. From the data in this study, it has been demonstrated that use of HPA lanolin before and during a period of repeated skin damage mimicking that seen during breast feeding, significantly protects the skin from the trauma and suggests that use of such products may be clinically useful for nursing mothers to prepare the skin prior to breast feeding and for continued use during the feeding period to ensure the trauma caused is minimized.