UK Baby Study Using a Baby Wash and Lotion Regimen

NCT03142984 | Terminated

• 2 other identifiers: CO-1610 1411 2628-SBCTCO-161014112628-SBCT
• Study Type: interventional
• Target: 82
• Locations: 1 country
• Sites: 2

Brief 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

Outcome Measures

Primary Outcomes (4)

• Change in neonatal skin condition score from baseline to 3 weeks

  Phase 1

  3 weeks

• Change in Transepidermal Water Loss (TEWL) from baseline to 12 weeks

  Phase 2

  12 weeks

• Change in stratum corneum hydration (corneometer) from baseline to 12 weeks

  Phase 2

  12 weeks

• Number of adverse events reported related to investigations products

  Phase 1

  3 weeks

Secondary Outcomes (5)

• Product Questionnaires

  3 weeks

• Change in neonatal skin condition score from baseline to 12 weeks

  12 weeks

• Change in stratum corneum surface water content (ATR-FTIR) from baseline to 12 weeks

  12 weeks

• Change in stratum corneum lipid structure (ATR-FTIR) from baseline to 12 weeks

  12 weeks

• Change in stratum corneum carboxylate levels (ATR-FTIR, marker of natural moisturizing factor levels and filaggrin expression) from baseline to 12 weeks

  12 weeks

Study Arms (2)

Phase 1

EXPERIMENTAL

An open use test in a cohort of newborn babies to confirm the tolerability and evaluate the acceptability of a new Baby Wash \& Shampoo product and Baby Lotion. Baby Wash \& Shampoo (F# 13217-070) Baby Lotion (F# 13217-071)

Other: Cosmetic Products

Phase 2

EXPERIMENTAL

An evaluator blind, randomized, 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 skincare practices without massage. Baby Wash \& Shampoo (F# 13217-070) Baby Lotion (F# 13217-071)

Other: Cosmetic Products

Interventions

Cosmetic Products OTHER

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)

Phase 1; Phase 2

Eligibility Criteria

• Age: 0 Days - 28 Days
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Newborn babies:
• Healthy, full-term, male or female newborns (37+ weeks gestation), with healthy normal skin
• Newborn must be within 0-14 days old at Baseline for Phase 1 and within 0-28 days old at Baseline for Phase 2
• Mothers:
• Mothers carrying singleton pregnancy of greater than or equal to (\>=) 37-weeks gestation
• Mother is the one who regularly cares for the newborn. The mother must be available to attend every study visit
• Mother must be willing and able to participate in and comply with a study that requires using test products as directed on her newborn throughout study period
• Mother must be 18 years of age or older

You may not qualify if:

• For both Newborn babies and Mother:
• History of a confirmed coronavirus disease 2019 (COVID-19) infection in the last 30 days
• Temperature \>=38.0 degree Celsius (°C) /100.4-degree Fahrenheit (°F), measured
• Use of fever reducers within the past 2 days of each onsite visit. Exception: The use of fever reducers will be acceptable in this timeframe as long as it for the appropriate indication (example teething, immunization, etc.) and not COVID related as per principal investigator (PI) assessment
• Is participating in another clinical study where the participant is currently part of an active intervention/treatment (current or planned during the study period)
• Newborn babies:
• Newborn has a chromosomal abnormality or other syndromic diagnosis
• Newborn has major congenital malformations or limb defects
• Newborn is currently admitted to a neonatal unit
• Newborn with health concerns
• Newborn with known allergies or adverse reactions to common topical skincare products
• Any condition requiring use of a topical or oral over the counter (OTC) or prescription medication, which in the investigator's judgment makes the subject ineligible or places the subject at risk. Child vitamins are allowed and should be listed on the Medical Information sheet (Health and Eligibility Questionnaire) under the Concurrent Medications section
• Newborn with a known condition of asthma or any related breathing problems
• Newborn with chronic medical conditions or treatments that could interfere with the study or pose a risk to the newborn (including known immunodeficiency or lung related conditions)
• Newborn with active localized or general infections including upper respiratory infections (ear, nose, throat, fever, cough, Et cetera \[etc.\]).

Sponsors & Collaborators

• Johnson & Johnson Consumer Inc. (J&JCI): lead
• University of Sheffield: collaborator

Study Sites (2)

Saint Mary's Hospital

Manchester, Machester, M13, 9WL, United Kingdom

Location

The Royal Hallamshire Hospital

Sheffield, S10 2JF, United Kingdom

Location

Related Links

• A 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

MeSH Terms

Interventions

Cosmetics

Intervention Hierarchy (Ancestors)

Specialty Uses of Chemicals; Chemical Actions and Uses; Household Products; Technology, Industry, and Agriculture

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 2, 2017
• First Posted: May 8, 2017
• Study Start: July 4, 2017
• Primary Completion: June 4, 2020
• Study Completion: June 4, 2020
• Last Updated: December 4, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will share

Locations

GB (2)