An interventional study of Skin Massage with Product in Skin Massage, sponsored by King's College London. Recruiting at 1 site in United Kingdom. Open to participants aged 0 Months to 6 Months, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-02-11.
Sponsored by King's College London · Not applicable, Interventional, and Other
This project aims to study whether regular skin massage in babies induces cutaneous inflammation and whether this inflammatory response is amplified in those receiving daily (vs bi-weekly or no) skin massage over an 8 week period. Specifically, it aims to:
Massaging the skin is thought to be beneficial to facilitate bonding between babies and their caregivers. Evidence shows that it can help blood flow and may also positively impact the baby's immune system. However, this has not been researched in detail before. In our study, we aim to understand how the skin immune system reacts to massage. We aim to establish if regular skin massage induces cutaneous immune system changes measured through pro-inflammatory cytokines in interstitial fluid (ISF), and whether this response is amplified in those receiving daily (vs bi-weekly or no) skin massage over an 8 week period.
How skin massage influences the cutaneous immune system has not been investigated to date. The study will aim to address the following hypotheses:
The study is split into two parts. In part 1, the ISF device will be piloted in the first 9 healthy babies enrolled in the study to optimise the pressure and length of time the device is used for. Participants will be invited to attend 1 visit to the Clinical Research Facility at St Thomas' Hospital, lasting approximately 1 hour for this non-invasive collection of skin fluid and skin barrier measurements. We can offer allergy testing to house dust mite, peanut, egg and milk for your baby, if you are interested.
Part 2 is a randomised controlled trial that will investigate how regular skin massage impacts the immune system in 100 healthy baby's. Participants will be randomly allocated to 1 of 3 groups for the 8 week period:
Participants will be asked to attend 3 visit to the Clinical Research Facility at St Thomas' Hospital, at baseline, Week 4 and Week 8 for some non-invasive skin assessments, including skin fluid (ISF) sampling, skin barrier measurements, skin swabs, tape strips and a skin prick allergy test to house dust mite, egg, peanut and milk.
King's College London is the lead sponsor of 506 studies on the registry; 125 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
No application of product and no massage.
Application of product containing oil- and aqueous-based components + skin massage twice a week
Other: Skin Massage with Product
Application of product containing oil- and aqueous-based components + skin massage daily
Other: Skin Massage with Product
Application of product containing oil- and aqueous-based components to baby's skin followed by a standardized massage.
Detection of inflammatory cytokine markers in ISF.
The release of allergy-related and barrier-related soluble mediators such as IL-10 and TGF-β as well as other Th1/Th2 and other inflammatory cytokines.
Time frame: 8 weeks
Detection of skin biology changes in ISF using genetic profiling (RNA sequencing) and proteomics.
RNA will be extracted on the ISF samples using a commercial kit. Quantification of gene expression profile will be performed with a Nanostring nCounter Analysis system. This will be used to assess panels of genes associated with allergy and inflammation. Proteomics will be conducted using mass spectrometry.
Time frame: 8 weeks
Detection of changes in barrier function
TEWL, a validated measure of skin barrier function, will be measured using a closed chamber TEWL instrument (Biox Aquaflux Model AF200) adjacent to the ISF sampling site.
Time frame: 8 weeks
To measure specific IgE to foods and aeroallergens
SPT to egg, milk, peanut and house dust mite.
Time frame: 8 weeks
To detect signals of skin microbiota e.g. bacterial diversity in addition to specific strains such as Staphylococci.
Skin microbiome swabs for microbial DNA extraction, next generation or shotgun sequencing to identify bacteria or other micro-organisms (such as viruses and fungi) will be taken. We will sample the skin flora at a 4cm2 site. The swab will be taken from the site of ISF sampling. The sample will be collected using an Isohelix® microbial DNA swabs moistened with two drops of normal saline. A (negative) control sample will be taken for each participant.
Time frame: 8 weeks
Plan to share: Undecided
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King's College London