Exploring the Cutaneous Immune Response to Skin Massage in Early Life (CUTIE)

February 9, 2026 updated by: King's College London

A Randomised Controlled Trial to Investigate How Regular Skin Massage Impacts the Immune System in Early Life

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:

  1. Establish if massage increases /decreases immune signals in the skin.
  2. Clarify if the effects of massage are enhanced with the frequency of massage. 3.) Assess changes in skin biology as a consequence of skin massage. 4.) Determine if massage impacts skin barrier function in the early years of life.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

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:

  1. Regular skin massage generates immune "warning" signals (such as cytokines), the precondition of the skin during healthy development, more so in those who have massaged daily (compared to no massage and bi-weekly massage).
  2. Skin massage enhances skin barrier function and bacterial diversity of the skin.

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:

  • Group 1 (control group): No moisturiser (emollient) will be applied to your baby's skin, and they will not receive any massage.
  • Group 2: You will apply a moisturiser (emollient) with oil and water-based components and massage your baby's skin twice a week.
  • Group 3: You will apply a moisturiser (emollient) with oil and water-based components and massage your baby's skin daily.

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.

Study Type

Interventional

Enrollment (Estimated)

109

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

Yes

Description

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:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: No application of product and no massage
No application of product and no massage.
Experimental: Twice-Weekly Massage with Product
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 to baby's skin followed by a standardized massage.
Experimental: Daily 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Detection of inflammatory cytokine markers in ISF.
Time Frame: 8 weeks
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.
8 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Detection of skin biology changes in ISF using genetic profiling (RNA sequencing) and proteomics.
Time Frame: 8 weeks
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.
8 weeks
Detection of changes in barrier function
Time Frame: 8 weeks
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.
8 weeks
To measure specific IgE to foods and aeroallergens
Time Frame: 8 weeks
SPT to egg, milk, peanut and house dust mite.
8 weeks
To detect signals of skin microbiota e.g. bacterial diversity in addition to specific strains such as Staphylococci.
Time Frame: 8 weeks
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.
8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

King's College London

Collaborators

Guy's and St Thomas' NHS Foundation Trust
Rosetrees Trust
Stoneygate Trust

Investigators

  • Principal Investigator: Carsten Flohr, Guy's and St Thomas' NHS Foundation Trust

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 2, 2026

Primary Completion (Estimated)

March 30, 2027

Study Completion (Estimated)

April 30, 2027

Study Registration Dates

First Submitted

November 13, 2025

First Submitted That Met QC Criteria

November 13, 2025

First Posted (Actual)

November 14, 2025

Study Record Updates

Last Update Posted (Actual)

February 11, 2026

Last Update Submitted That Met QC Criteria

February 9, 2026

Last Verified

October 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 173023
  • CF-2021-2\108 (Other Grant/Funding Number: RoseTrees Trust and Stoneygate Trust)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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