Exploring the Cutaneous Immune Response to Skin Massage in Early Life
ConditionSkin Massage
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age0-6
SponsorKing's College London
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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.
Disqualifiers
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 design
Design model
Parallel
Treatments tested in this trial
Skin Massage with Product
Other interventionApplication of product containing oil- and aqueous-based components to baby's skin followed by a standardized massage.
Treatment groups
109 Participants
are divided into 3 treatment groupsGroup A: No application of product and no massageNo intervention 0 interventions
Group B: Twice-Weekly Massage with ProductExperimental treatment 1 intervention
Group C: Daily Massage with ProductExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
8 weeksSecondary outcomes
1
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.
Time frame
8 weeks2
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.
Time frame
8 weeks3
To measure specific IgE to foods and aeroallergens
SPT to egg, milk, peanut and house dust mite.
Time frame
8 weeks4
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.
Time frame
8 weeksSponsors and contacts
Click on the lead sponsor to view all of their trials.
King's College London
Lead sponsor
Guy's and St Thomas' NHS Foundation Trust
Collaborator
Rosetrees Trust
Collaborator
Stoneygate Trust
Collaborator
Source ClinicalTrials.gov