Clinical Study of Partially Hydrolysed Protein Infant Formula on Trans-epidermal Water Loss (TEWL) (RASH)

  • End date
    Jun 3, 2024
  • participants needed
  • sponsor
    Société des Produits Nestlé (SPN)
Updated on 3 April 2023
Accepts healthy volunteers


This is a single-centre, prospective, randomized, open-label, controlled trial of 200 infants 42±7 days of age. Subjects will be randomized to one of two open label feeding intervention

  • Intact Cow's Milk Protein Formula Group (CMFG) (n = 100) or
  • Partially Hydrolysed Whey Formula Group (pHFG) (n = 100).


Atopic dermatitis (AD) affects 15 - 30% of children. Approximately 45% of these cases have an onset within the first 6 months of life and 60% develop within the first year (Bieber 2010). Besides environmental factors, the aetiology of AD has been found to be associated with genetic variants involved in skin barrier function defect and inflammation, leading to dry skin with increases in susceptibility to environmental exposures (Bieber 2008).

Partially hydrolysed cow's milk (whey) protein infant formula (pHF) has been shown to be effective in prevention of AD, both among at-risk and healthy infants (Exl, Deland et al. 2000, von Berg, Koletzko et al. 2003, Jingrana and Dunjina 2015). However, to date there are no published pediatric data to document the relationship between partially hydrolysed protein formulas and skin barrier function, specifically evaluating the effect of pHF on Trans-epidermal Water Loss (TEWL) among infants. Therefore, this study aims to evaluate the effect on skin barrier function as measured by TEWL and we hypothesize that infants consuming partially hydrolysed starter formula will have lower TEWL when compared infants consuming intact cow's milk protein starter formula.

Condition Atopic Dermatitis, Skin Condition
Treatment Intact Cow's Milk Protein Formula, Partially Hydrolysed Whey Formula
Clinical Study IdentifierNCT04763512
SponsorSociété des Produits Nestlé (SPN)
Last Modified on3 April 2023


Yes No Not Sure

Inclusion Criteria

Infants 42± 7 days of age at enrolment (date of birth = age 0)
Infants who have been born full-term gestational birth (≥ 37 completed weeks of gestation) and having a birth weight ≥ 2.5 kg and ≤ 4.5 kg
Parents /caregivers must agree to follow study procedures and recommended skincare routines, such as avoidance of moisturizers or other skincare products on the primary sites of interest
Parent(s) must have already independently elected before enrolment to formula feed and less than 30% of intake will be from breastmilk

Exclusion Criteria

Known and diagnosed cow's milk protein allergy/intolerance
Infants currently using or have ever used partially hydrolysed protein formulas
Infants who have ever used topical corticosteroids, calcineurin inhibitors and/or any other physician-recommended treatments for skin conditions after birth
Infants who have been introduced to complementary foods
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