Skip to main content
. 2021 Feb 5;2021(2):CD013534. doi: 10.1002/14651858.CD013534.pub2

NCT03142984.

Study name Randomized Controlled Trial of Gentle Touch/Early Massage With a New Wash and Lotion Regimen for Improved Skin Barrier Strength, Parental Bonding, and Physical Development in Newborn Babies: The Barrier Optimizing Skincare for Newborn Development (BOND) Trial
Methods Randomised, single‐group assignment 
Participants 150 participants
Interventions Experimental: phase 1
An open‐use test in a cohort of newborn babies to confirm tolerability and evaluate acceptability of a new Baby Wash & Shampoo product and Baby Lotion
Baby Wash & Shampoo (F# 13217‐070), Baby Lotion (F# 13217‐071)
Experimental: phase 2
An evaluator‐blind, randomised, controlled trial to determine whether a wash and lotion regimen used for 12 weeks can strengthen the skin barrier in newborns when compared to standard skin care practices without massage
Baby Wash & Shampoo (F# 13217‐070), Baby Lotion (F# 13217‐071), Alternative Baby Wash & Shampoo (GTIN/UPC # 5011451106260)
Outcomes Primary outcomes: 

  1. Change in neonatal skin condition score from baseline to 3 weeks [Time Frame: 3 weeks]

  2. Change in transepidermal water loss (TEWL) from baseline to 12 weeks [Time Frame: 12 weeks]

  3. Change in stratum corneum hydration (corneometer) from baseline to 12 weeks [Time Frame: 12 weeks]

  4. Number of adverse events reported related to investigational products [Time Frame: 3 weeks]


Secondary outcomes: 

  1. Product questionnaires [Time Frame: 3 weeks]

  2. Change in neonatal skin condition score from baseline to 12 weeks [Time Frame: 12 weeks]

  3. Change in stratum corneum surface water content (ATR‐FTIR) from baseline to 12 weeks [Time Frame: 12 weeks] 

  4. Change in stratum corneum lipid structure (ATR‐FTIR) from baseline to 12 weeks [Time Frame: 12 weeks]

  5. Change in stratum corneum carboxylate levels (ATR‐FTIR, marker of natural moisturising factor levels and filaggrin expression) from baseline to 12 weeks [Time Frame: 12 weeks]
Starting date 4 July 2017 to 17 March 2021
Contact information No contact details on clinical trials 
Notes https://clinicaltrials.gov/ct2/show/NCT03142984