Exploring the Cutaneous Immune Response to Skin Massage in Early Life
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Skin Massage with Product.
- Who it may be relevant to
- Registry conditions: Skin Massage. Basic parameters: 0 months — 6 months · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United Kingdom
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Randomised Controlled Trial to Investigate How Regular Skin Massage Impacts the Immune System in Early Life
Overview
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.
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.
Interventions
- Other Skin Massage with Product
Application of product containing oil- and aqueous-based components to baby's skin followed by a standardized massage.
Primary outcome measures
- Detection of inflammatory cytokine markers in ISF. [Time frame: 8 weeks]
Secondary outcome measures (4)
- 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]
Eligibility criteria
Inclusion criteria
- 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.
Exclusion criteria
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Other
Study locations
United Kingdom · 1 center
- St. Thomas' Hospital — London
Identifiers
NCT: NCT07228728 · 173023 · CF-2021-2\108