Exploring the cutaneous immune response to skin massage in early life (CUTIE study)

A randomised controlled trial to investigate how regular skin massage impacts the immune system in early life

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN15280333

Enrollment

109

Registered

2025-11-04

Start date

2026-01-02

Completion date

Unknown

Last updated

2025-11-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

How regular skin massage impacts the immune system in early life Other

Interventions

Part 1: ISF (Interstitial fluid) is a fluid found between the top layers of the skin, a non-invasive device will be used to collect this. The ISF device will be piloted in the first 9 healthy babies e

Eligibility

Sex/Gender

All

Age

0 Months to 6 Months

Inclusion criteria

Inclusion criteria: 1. Healthy babies born at term up to 6 months old 2. Ability of parents/guardians/caregivers to provide written informed consent for study participation 3. Willingness of parents/guardians/caregivers to comply with all study requirements

Exclusion criteria

Exclusion criteria: 1. Parents/guardians/caregivers unable to give informed consent 2. Personal history of inflammatory skin disease (in particular AD) 3. Active involvement in another interventional research study

Design outcomes

Primary

Measure	Time frame
Levels of IL-10, TGF-ß, Th1-related cytokines (e.g. IFN-?), Th2-related cytokines (e.g. IL-4, IL-5, IL-13), other inflammatory cytokines (e.g. TNF-a, IL-6) are measured using multiplex immunoassay in skin interstitial fluid at baseline, week 4 and week 8	—

Secondary

Measure	Time frame
1. Gene expression profiles associated with allergy and inflammation are measured using RNA sequencing with Nanostring nCounter Analysis system on skin interstitial fluid at baseline, week 4 and week 8 2. Protein expression profiles associated with skin biology are measured using mass spectrometry-based proteomics on skin interstitial fluid at baseline, week 4 and week 8 3. Transepidermal water loss (TEWL) is measured using Biox Aquaflux Model AF200 at baseline, week 4 and week 8 4. Sensitisation to egg, milk, peanut and house dust mite is measured using skin prick testing at baseline and week 8 5. Skin microbiota composition including bacterial diversity and presence of specific strains such as Staphylococci is measured using microbial DNA extraction and next generation sequencing from skin swabs at baseline, week 4 and week 8	—

Measure

Time frame

1. Gene expression profiles associated with allergy and inflammation are measured using RNA sequencing with Nanostring nCounter Analysis system on skin interstitial fluid at baseline, week 4 and week 8 2. Protein expression profiles associated with skin biology are measured using mass spectrometry-based proteomics on skin interstitial fluid at baseline, week 4 and week 8 3. Transepidermal water loss (TEWL) is measured using Biox Aquaflux Model AF200 at baseline, week 4 and week 8 4. Sensitisation to egg, milk, peanut and house dust mite is measured using skin prick testing at baseline and week 8 5. Skin microbiota composition including bacterial diversity and presence of specific strains such as Staphylococci is measured using microbial DNA extraction and next generation sequencing from skin swabs at baseline, week 4 and week 8

—

Countries

England, United Kingdom

Contacts

Public ContactPreeti Khurana

gstt.cutie.study@nhs.net-

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026