Introducing Landmark Clinical Trials On Newborn Cleansing Methods

Raising the bar in evidence-based care 

JOHNSON’S® Baby has always adhered to the strictest standards in ingredient selection and safety, formulations, manufacturing and post-market surveillance. However it is recognised that Healthcare Professionals (HCP’s) are constantly seeking Evidence Based research to support product recommendation.  Therefore JOHNSON'S® Baby carried out an independent clinical trial with a multi-disciplinary team, to provide scientific evidence on the safety of our products.

Meet the investigative team

Working in partnership with leading maternity hospitals and the University of Manchester, UK, the team was led by midwives in collaboration with a multidisciplinary group of HCPs, including a paediatric dermatologist, biomedical engineers and statisticians.

Advancing the standard in newborn skincare testing

This multidisciplinary team of investigators put the safety of JOHNSON’S® Baby TOP-TO-TOE® Wash and JOHNSON’S® Baby Skincare Wipes Fragrance Free to the ultimate test by comparing their effects on newborn skin to water alone, often considered to be the benchmark in terms of mildness1, 2. Large-scale, long-term and robust, these randomised controlled trials (RCT's) provide key evidence on the best care for newborn skin.

A thorough process provides robust clinical results

Qualitative research

  • A qualitative study exploring the views of HCPs and mothers on newborn bathing practices showed that they doubted water’s ability to be an effective cleanser. Yet, HCPs believed that there was only evidence to support using water alone. This research highlighted inconsistencies in practice, confirming the need to conduct robust trials on newborn cleansing methods3.

Study design and protocol

  • Aiming for the gold standard in terms of scientific evidence, two randomised, assessor-blinded, controlled trials were designed. These trials looked at the effects of JOHNSON’S® Baby TOP-TO-TOE® Wash and JOHNSON’S® Baby Skincare Wipes Fragrance Free compared with water alone and cotton wool and water, respectively.
  • The study design and protocol received full ethical approval from the University of Manchester and the Research and Development Trusts at the Liverpool Women’s Hospital.

Clinical trials and results analysis

  • Healthy newborn babies delivered at 37 weeks’ gestation or more and their mothers were recruited for participation at the Liverpool Women’s Hospital and at the Central Manchester Foundation Trust. Newborn babies with a family history of eczema were included in the study.
  • Midwives conducted baby skin measurements (evaluating TEWL, hydration, skin surface pH etc.) at participants’ homes and mothers were asked to record their observations in diaries.

  • Statistical analyses and study reports were completed. Results were first presented at the congress of the International Confederation of Midwives in June 20114 and was submitted for publication.

1.Lavender, T., et al. Infant Skin-cleansing Product Versus Water: A Pilot Randomized, Assessor-blinded Controlled Trial. BMC Pediatrics. Vol. 11, No. 35. Pg 1-9. 2011.

2.Lavender, T., et al. Effect on Skin Hydration of Using Baby wipes to Clean the Napkin Area of Newborn Babies: Assessor-blinded Randomised Controlled Equivalence Trial. BMC Pediatrics. Vol. 12, No. 59. 2011.

3.Lavender T., et al. A Qualitative Study Exploring Women’s and Health Professionals’ Views of Newborn Bathing Practices. Evidence Based Midwifery. Vol. 7, No. 4. Pg 112-121. 2009.

4.Lavender T., et al. Randomized, Controlled Trial Evaluating a Baby Wash Product on Skin Barrier Function in Healthy, Term Neonates. JOGNN. Vol. 42, Issue 2. Pg 203-214. 2013.