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UK Baby Study Using a Baby Wash and Lotion Regimen

NCT03142984 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 82

Last updated 2023-12-04

No results posted yet for this study

Summary

The skin of a newborn has a sensitive skin barrier relative to an older child and an adult. Newborn's skin, for example, is extremely vulnerable to damage by environmental agents such as harsh detergents, some topical oils, and other irritant chemicals. Evolving perspectives on barrier dysfunction in newborn babies has led to the idea that there may be a window of opportunity in the first few months of a newborn's life to change the environmental agents that their skin is exposed to in order to maximize skin health. These environmental changes could involve the use of optimally formulated wash products and emollients, as well as the removal of all other irritant substances that could damage the skin barrier. Further research is required to identify skincare practices that are harmful and those that are positive, and to ultimately ascertain what the optimum skincare routine should be.

An important skincare strategy is to identify an appropriate regimen (use of topical emollients and wash products) that will be used to maintain healthy skin in the future. Baby massage in particular has been shown to enhance the bond between mother and newborn, highlighting that early intervention can support skin health while also being a rewarding experience.

Gentle Touch/Early Massage:

Apply the lotion with a gentle touch to communicate love to your baby and to create a special bonding moment with skin-to-skin touch. Your touch nurtures baby's social, emotional and physical development. Please take your time to apply consciously the lotion on the whole body of your baby while engaging with her/him. Your touch, light but present, will be consistent across all the face and body areas, it is delicate and soft but more than just applying the lotion.

Parents/guardians are using products to help care for their newborn's skin and there is a need to help parents/guardians identify the most appropriate products through research. This study aims to help address this need.

Conditions

  • Newborns

Interventions

OTHER

Cosmetic Products

Phase 1: Baby Wash \& Shampoo (F# 13217-070) Baby Lotion (F# 13217-071) Phase 2: Baby Wash \& Shampoo (F# 13217-070) Baby Lotion (F# 13217-071)

Sponsors & Collaborators

  • University of Sheffield

    collaborator OTHER

  • Johnson & Johnson Consumer Inc. (J&JCI)

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
0 Days
Max Age
28 Days
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-07-04
Primary Completion
2020-06-04
Completion
2020-06-04

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03142984 on ClinicalTrials.gov