Exploring the Cutaneous Immune Response to Skin Massage in Early Life
NCT ID: NCT07228728
Last Updated: 2025-11-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
109 participants
INTERVENTIONAL
2026-01-02
2027-04-30
Brief Summary
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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.
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Detailed Description
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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. 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 and a skin prick allergy test to house dust mite, egg, peanut and milk.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
SINGLE
Study Groups
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No application of product and no massage
No application of product and no massage.
No interventions assigned to this group
Twice-Weekly Massage with Product
Application of product containing oil- and aqueous-based components + skin massage twice a week
Skin Massage with Product
Application of product containing oil- and aqueous-based components to baby's skin followed by a standardized massage.
Daily Massage with Product
Application of product containing oil- and aqueous-based components + skin massage daily
Skin Massage with Product
Application of product containing oil- and aqueous-based components to baby's skin followed by a standardized massage.
Interventions
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Skin Massage with Product
Application of product containing oil- and aqueous-based components to baby's skin followed by a standardized massage.
Eligibility Criteria
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Inclusion Criteria
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
2. Personal history of inflammatory skin disease (in particular atopic dermatitis)
3. Active involvement in another interventional research study
0 Months
6 Months
ALL
Yes
Sponsors
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Guy's and St Thomas' NHS Foundation Trust
OTHER
Rosetrees Trust
OTHER
Stoneygate Trust
UNKNOWN
King's College London
OTHER
Responsible Party
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Principal Investigators
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Carsten Flohr
Role: PRINCIPAL_INVESTIGATOR
Guy's and St Thomas' NHS Foundation Trust
Locations
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St. Thomas' Hospital
London, , United Kingdom
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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CF-2021-2\108
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
173023
Identifier Type: -
Identifier Source: org_study_id
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