Ignite Creation Date:
2025-12-26 @ 10:34 AM
Ignite Modification Date:
2026-03-13 @ 8:10 PM
Study NCT ID:
NCT07228728
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-11-14
First Post:
2025-11-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Exploring the Cutaneous Immune Response to Skin Massage in Early Life
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D004364', 'term': 'Pharmaceutical Preparations'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 109}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-01-02', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-10', 'completionDateStruct': {'date': '2027-04-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-13', 'studyFirstSubmitDate': '2025-11-13', 'studyFirstSubmitQcDate': '2025-11-13', 'lastUpdatePostDateStruct': {'date': '2025-11-14', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-11-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2027-03-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Detection of inflammatory cytokine markers in ISF.', 'timeFrame': '8 weeks', 'description': '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.'}], 'secondaryOutcomes': [{'measure': 'Detection of skin biology changes in ISF using genetic profiling (RNA sequencing) and proteomics.', 'timeFrame': '8 weeks', 'description': '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.'}, {'measure': 'Detection of changes in barrier function', 'timeFrame': '8 weeks', 'description': '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.'}, {'measure': 'To measure specific IgE to foods and aeroallergens', 'timeFrame': '8 weeks', 'description': 'SPT to egg, milk, peanut and house dust mite.'}, {'measure': 'To detect signals of skin microbiota e.g. bacterial diversity in addition to specific strains such as Staphylococci.', 'timeFrame': '8 weeks', 'description': '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.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Massage', 'Early life', 'dermatology', 'Immune System', 'Immune Response', 'Infant Development', 'Skin barrier', 'Microbiome', 'Interstitial Skin fluid'], 'conditions': ['Skin Massage']}, 'descriptionModule': {'briefSummary': '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:\n\n1. Establish if massage increases /decreases immune signals in the skin.\n2. 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.', 'detailedDescription': '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.\n\nHow skin massage influences the cutaneous immune system has not been investigated to date. The study will aim to address the following hypotheses:\n\n1. 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).\n2. Skin massage enhances skin barrier function and bacterial diversity of the skin.\n\nThe 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.\n\nPart 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:\n\n* Group 1 (control group): No moisturiser (emollient) will be applied to your baby\'s skin, and they will not receive any massage.\n* Group 2: You will apply a moisturiser (emollient) with oil and water-based components and massage your baby\'s skin twice a week.\n* Group 3: You will apply a moisturiser (emollient) with oil and water-based components and massage your baby\'s skin daily.\n\nParticipants 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '6 Months', 'minimumAge': '0 Months', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Healthy babies born at term up to 6 months old\n2. Ability of parents/guardians/caregivers to provide written informed consent for study participation\n3. Willingness of parents/guardians/caregivers to comply with all study requirements.\n\nExclusion Criteria:\n\n1. Parents/guardians/caregivers unable to give informed consent.\n2. Personal history of inflammatory skin disease (in particular atopic dermatitis)\n3. Active involvement in another interventional research study'}, 'identificationModule': {'nctId': 'NCT07228728', 'acronym': 'CUTIE', 'briefTitle': 'Exploring the Cutaneous Immune Response to Skin Massage in Early Life', 'organization': {'class': 'OTHER', 'fullName': "King's College London"}, 'officialTitle': 'A Randomised Controlled Trial to Investigate How Regular Skin Massage Impacts the Immune System in Early Life', 'orgStudyIdInfo': {'id': '173023'}, 'secondaryIdInfos': [{'id': 'CF-2021-2\\108', 'type': 'OTHER_GRANT', 'domain': 'RoseTrees Trust and Stoneygate Trust'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'No application of product and no massage', 'description': 'No application of product and no massage.'}, {'type': 'EXPERIMENTAL', 'label': 'Twice-Weekly Massage with Product', 'description': 'Application of product containing oil- and aqueous-based components + skin massage twice a week', 'interventionNames': ['Other: Skin Massage with Product']}, {'type': 'EXPERIMENTAL', 'label': 'Daily Massage with Product', 'description': 'Application of product containing oil- and aqueous-based components + skin massage daily', 'interventionNames': ['Other: Skin Massage with Product']}], 'interventions': [{'name': 'Skin Massage with Product', 'type': 'OTHER', 'description': "Application of product containing oil- and aqueous-based components to baby's skin followed by a standardized massage.", 'armGroupLabels': ['Daily Massage with Product', 'Twice-Weekly Massage with Product']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'SE1 7EH', 'city': 'London', 'country': 'United Kingdom', 'contacts': [{'name': 'Preeti Khurana', 'role': 'CONTACT', 'email': 'gstt.cutie.study@nhs.net', 'phone': '020 7188 7188', 'phoneExt': '57716'}], 'facility': "St. Thomas' Hospital", 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}], 'centralContacts': [{'name': 'Preeti Khurana', 'role': 'CONTACT', 'email': 'gstt.cutie.study@nhs.net', 'phone': '020 7188 7188', 'phoneExt': '57716'}], 'overallOfficials': [{'name': 'Carsten Flohr', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Guy's and St Thomas' NHS Foundation Trust"}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "King's College London", 'class': 'OTHER'}, 'collaborators': [{'name': "Guy's and St Thomas' NHS Foundation Trust", 'class': 'OTHER'}, {'name': 'Rosetrees Trust', 'class': 'OTHER'}, {'name': 'Stoneygate Trust', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}