Clinical Trial Details
— Status: Terminated
Administrative data
| NCT number |
NCT03142984 |
| Other study ID # |
CO-1610 1411 2628-SBCT |
| Secondary ID |
CO-161014112628- |
| Status |
Terminated |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
July 4, 2017 |
| Est. completion date |
June 4, 2020 |
Study information
| Verified date |
November 2023 |
| Source |
Johnson & Johnson Consumer and Personal Products Worldwide |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
Description:
2 BACKGROUND 2.1 SKIN DEVELOPMENT FROM BIRTH The skin visually reaches maturity anywhere
between 30 and 37 weeks of gestational age, yet neonatal and infant skin exhibits a
'sensitive' nature.1 To emphasize this, 78% of participants in one study reported a 'rash' in
the first month of their newborns life.2 Its now clear that this sensitivity is related to
the functioning of the skin barrier, formed by the skins uppermost layer, the stratum
corneum. It takes more than 12 months following birth before the stratum corneum reaches
structural maturity at a microscopic level.3 This is reflected by the reduced function of the
skin barrier during this time, indicated by elevated transepidermal water loss (TEWL).4 The
reduced skin barrier function exhibited during the months following birth increases the risk
of irritant and allergen penetration through the skin and consequently the development of
dermatological conditions.
2.2 SKIN CLEANSING For both children and adults, bathing to cleanse the skin is a hygienic
necessity. The goal of hygiene is the preservation of skin health. Cleansing is essential to
remove: potentially pathogenic bacteria, such as those from faeces; bodily secretions, such
as faeces and saliva that contain enzymes (lipases and proteases) that breakdown the skin
barrier; foods, including milk that can disturb skin homeostasis and peanuts that can cause
sensitization; and other chemical irritants in the environment.1 However there is a balance
to be made between cleansing the skin and preservation of its homeostatic properties such as
skin barrier function and integrity.5 For instance some soaps and cleansers used to clean the
skin that contain harsh detergents, such as sodium lauryl sulfate (SLS), increase skin
surface pH, reduce skin hydration and alter skin barrier function.6 Nevertheless cleansers
are important. Washing with water alone is ineffective at removing fat-soluble substances
from skin.7 The surfactants in cleansers are required to remove these potential fat-soluble
irritants. Moreover, washing with tap water alone leads to the extraction of water-soluble
metabolites from the skin, including NMF, and causes mild irritation and increased skin
dryness. Washing with hard water, as opposed to soft water, in particular is consistently
reported to increase the risk of developing AD. A balance is therefore required between
effective cleansing and the need for cleansers that are kind to the skin.8 There is now a
wide range of detergents and detergent complexes available for the use in cleansing with a
spectrum of effects on the skin from harsh irritant effects, such as those caused by SLS, to
very mild effects comparable to washing with water alone.
The use of cleansing products compared to water alone for bathing babies has been subject to
a systematic review,9 which focused on two trials. One study10 comprised of four trial arms,
including washing twice weekly with a wash gel product; bathing twice weekly with water then
applying a cream; bathing with wash gel and applying cream after bathing; and bathing with
water only. The second study11 compared two different liquid cleansers with water for bathing
infants. The results of these studies indicated no harm to skin barrier function with the
tested cleaning agents, although the number of babies in each treatment arm was small.9 A
large UK-based trial of a mild pH 5.5 liquid SLS-free cleanser versus water alone in bathing
newborn babies for the first 28 days, conducted since this systematic review, showed
essentially no differences in TEWL, hydration, skin surface pH and clinical observations.12
Skin hydration was raised in the cleanser arm at 14 days postnatal (ITT: mean wash score 49.7
(SD 9.2) vs. water 46.7 (SD 8.4), p=0.02, 95% CI -5.46 to -0.43), but was equal to those in
the water group at 28 days postnatal. The evidence suggests that while some cleansers,
particularly those containing SLS, can be harsh on the skin, other cleansers are available
that have very mild effects on the skin, effects as least as mild as washing with water
alone. The advantage of these mild cleansers is their increased cleansing efficacy and
cosmetic acceptability. Given the limited number of robust clinical trials in this area there
is a need to conduct further research to enable healthcare professionals and parents/carers
to identify suitable and safe wash products and cleansing regimens for their babies and
infants.
2.3 CURRENT GUIDANCE ON SKIN CLEANSING Current guidance on skin cleansing has been limited by
the lack of available high quality evidence, leading to a number of differing
guidelines.13-17 Hence, there has been confusion amongst health professionals in relation to
appropriate advice.18 Guidance from the World Health Organization13 is limited to bathing a
baby in warm water, at least 6 hours following birth. There is no United Kingdom NICE
(National Institute for Clinical Excellence) guidance specifically about neonatal skin care.
The NICE Postnatal Care Guidelines17 contains one paragraph about neonatal skin care which
recommends that cleansing agents, lotions or medicated wipes should not be used; using only a
mild non-perfumed soap where necessary. No evidence is cited to support this practice, and
recent trials have demonstrated that the use of products can significantly reduce the
development of dermatological conditions. In contrast to the NICE Postnatal Care Guideline,
AWOHNN14,19 guidance is more comprehensive and specific and recommends use of a cleansing
wash, with a neutral pH, that has been specifically formulated for use on babies.
Although there are guidelines available, not all are evidence based and debate still remains
on best practice. The most recent guideline, produced by a panel of experts, advocates the
use of wash products. Based upon this guideline the recently NHIR-funded Barrier Enhancement
for Eczema Prevention (BEEP) study investigating an early skincare intervention in babies
provided the following advice to participants: (1) avoid soap and bubble bath; (2) use a
mild, fragrance-free synthetic cleanser designed specifically for babies; (3) avoid bath oils
and additives; (4) use a mild, fragrance-free shampoo designed specifically for babies and
avoid washing the suds over the baby's body; and (5) avoid using baby wipes, where
possible.20 The challenge for parents is identifying 'mild' products, and so this advice
currently has limited real-world value until more evidence on the effects of different
products becomes available. There have been substantial advances in formulation technology of
baby wash products since some of these guidelines were written highlighting the need for
further research into neonatal skincare practices.10-12,21-24 2.4 INFANT SKIN MASSAGE Infant
massage is a traditional practice advocated and used throughout the world to promote physical
and mental development.25 Moreover it is an integral aspect of topical emollient use in
newborn babies because emollient lotions and creams applied to the skin must be rubbed, or
'massaged', in. In the UK more than half of maternity/neonatal units endorse the use of
massage oil as part of infant skincare.26 A number of studies into infant massage have
identified potential physical and mental benefits that require validation.25 These benefits
include: increased weight, length, head circumference; improved sleep; reduced episodes of
crying/fussing; improved motor skills (gross and fine); enhanced personal and social
behavior; and improved psychomotor development. The development of a secure attachment
between parent and infant in the early years is highly protective in promoting healthy
psychosocial and emotional development. Infant massage may have a role in facilitating the
development of early sensitive parent - infant relationships and attunement, known precursors
to the development of secure attachments27. At 2 months of age the
hypothalamic-pituitary-adrenocortical system produces and regulates glucocorticoid cortisol
in response to stress. Sensitive and attuned parents-infant interactions are associated with
reduced cortisol excretion and thus improved affect regulation in infants28. A randomized
controlled trial conducted by Gurol and Polat on infant massage in 120 newborn babies found a
significant positive effect of the intervention on attachment between the mother and baby.29
The association between early secure attachment relationships, and the promotion of healthy
brain development, emotional wellbeing and mental health is increasingly recognized and
associated with improved outcomes for children across all domains of functioning30. Although
there is significant research in the area of infant / child massage which supports positive
benefits, very few studies have specifically studied the effects of massage in combination
with a specific product form as a focus of the study.
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.
Improved parent-infant interaction is currently an overlooked potential benefit of emollient
use in newborn babies in most studies reported. Care is needed when selecting an emollient
medium for infant massage because some topical oils have been found to damage the skin
barrier.31-33 This study aims to investigate the effects of an emollient lotion specially
formulated for use in newborns.
2.5 PATIENT AND PUBLIC INVOLVEMENT We have taken the views of parents with young babies into
consideration when developing this study so that the findings have the greatest meaning and
impact to them. In 2008 the views of 26 mothers, 20 midwives and 10 health visitors on baby
bathing practices were ascertained as part of a qualitative study.18 Since then we have
gathered the views of parents on baby bathing practices and clinical research on these
practices as part of several clinical studies.26,31,34-37 Parents are using products to help
care for their baby's skin and there is a need to help parents identify the most appropriate
products through research. This study aims to help address this need.
