Skin MassageCUTIENCT07228728
Exploring the Cutaneous Immune Response to Skin Massage in Early Life
A study testing Skin Massage with Product in people with Skin Massage, run by King's College London at 1 site in United Kingdom.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 0 to 6 monthsHealthy volunteers can take part
- Conditions the study is for
- Skin Massage
- What is being tested?
- Skin Massage with Product
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 109 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 2 Jan 2026to 30 Apr 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 0 to 6 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Healthy babies born at term up to 6 months old
- Ability of parents/guardians/caregivers to provide written informed consent for study participation
- Willingness of parents/guardians/caregivers to comply with all study requirements.
Who cannot join
- Parents/guardians/caregivers unable to give informed consent.
- Personal history of inflammatory skin disease (in particular atopic dermatitis)
- Active involvement in another interventional research study
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United Kingdom1 site, 1 recruiting
- Recruiting
St. Thomas' Hospital
London, SE1 7EH
Preeti Khurana, 020 7188 7188 ext. 57716, gstt.cutie.study@nhs.net
About this study
Official title: 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:
- Establish if massage increases /decreases immune signals in the skin.
- 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.
Read the 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:
- 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).
- 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.
- Conditions
- Skin Massage
- Being tested
- Skin Massage with Product
- Keywords
- Massage, Early life, dermatology, Immune System, Immune Response, Infant Development, Skin barrier, Microbiome, Interstitial Skin fluid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Skin Massage with ProductOther
Application of product containing oil- and aqueous-based components to baby's skin followed by a standardized massage.
| Study group | Role | What they receive |
|---|---|---|
| No application of product and no massage | No intervention | No application of product and no massage. |
| Twice-Weekly Massage with Product | Experimental | Application of product containing oil- and aqueous-based components + skin massage twice a week Receives: Other: Skin Massage with Product |
| Daily Massage with Product | Experimental | Application of product containing oil- and aqueous-based components + skin massage daily Receives: Other: Skin Massage with Product |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 8 weeks
Secondary outcomes (4)
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.
Measured: 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.
Measured: 8 weeks
To measure specific IgE to foods and aeroallergens
SPT to egg, milk, peanut and house dust mite.
Measured: 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.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2025
- Study start2 Jan 2026
- Primary completion30 Mar 2027 (estimated)
- Study completion30 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Skin MassageStudies of the same condition, open and under way.
- More trials run by King's College LondonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 109 participants (estimated)
Sponsor and investigators
- Lead sponsor
- King's College London
- Sponsor type
- University, hospital or other
- Collaborators
- Guy's and St Thomas' NHS Foundation Trust, Rosetrees Trust, Stoneygate Trust
- Responsible party
- Sponsor
- Investigators
- Carsten Flohr, Principal investigator, Guy's and St Thomas' NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07228728
- Sponsor's protocol ID
- 173023
- Other IDs
- CF-2021-2\108
- Acronym
- CUTIE
- Status last verified
- Oct 2025
- First submitted
- 13 Nov 2025
- Last updated
- 11 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised Controlled Trial to Investigate How Regular Skin Massage Impacts the Immune System in Early Life
- ClinicalTrials.gov ID
- NCT07228728
- Acronym / sponsor ID
- CUTIE / 173023
- Conditions
- Skin Massage
- Keywords
- Massage, Early life, dermatology, Immune System, Immune Response, Infant Development, Skin barrier, Microbiome
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 109 participants (estimated)
- Lead sponsor
- King's College LondonUniversity, hospital or other
- Collaborators
- Guy's and St Thomas' NHS Foundation Trust, Rosetrees Trust, Stoneygate Trust
- Study start
- 2 Jan 2026 (actual)
- Primary completion
- 30 Mar 2027 (estimated)
- Study completion
- 30 Apr 2027 (estimated)
- First posted
- 14 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Establish if massage increases /decreases immune signals in the skin.
- 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.
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:
- 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).
- 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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| No application of product and no massage | No intervention | –No application of product and no massage. |
| Twice-Weekly Massage with Product | Experimental | Other: Skin Massage with ProductApplication of product containing oil- and aqueous-based components + skin massage twice a week |
| Daily Massage with Product | Experimental | Other: Skin Massage with ProductApplication of product containing oil- and aqueous-based components + skin massage daily |
Who may qualify
- Ages
- 0 to 6 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Healthy babies born at term up to 6 months old
- Ability of parents/guardians/caregivers to provide written informed consent for study participation
- Willingness of parents/guardians/caregivers to comply with all study requirements.
Key exclusion criteria (3 listed)
- Parents/guardians/caregivers unable to give informed consent.
- Personal history of inflammatory skin disease (in particular atopic dermatitis)
- Active involvement in another interventional research study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Skin Massage with ProductApplication of product containing oil- and aqueous-based components to baby's skin followed by a standardized massage. | Other | Daily Massage with Product, Twice-Weekly Massage with Product |
Primary outcome
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.
4 secondary outcomes
Detection of skin biology changes in ISF using genetic profiling (RNA sequencing) and proteomics.
Time frame: 8 weeks
Detection of changes in barrier function
Time frame: 8 weeks
To measure specific IgE to foods and aeroallergens
Time frame: 8 weeks
To detect signals of skin microbiota e.g. bacterial diversity in addition to specific strains such as Staphylococci.
Time frame: 8 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Carsten Flohr principal investigator
Guy's and St Thomas' NHS Foundation Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Skin Massage with Product in people with Skin Massage, run by King's College London at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 11 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Preeti Khurana (020 7188 7188 ext. 57716, gstt.cutie.study@nhs.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Detection of inflammatory cytokine markers in ISF. (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Feb 2026.