NCT07228728

Brief 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. 1.Establish if massage increases /decreases immune signals in the skin.
  2. 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
109

participants targeted

Target at P50-P75 for not_applicable

Timeline
12mo left

Started Jan 2026

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress26%
Jan 2026Apr 2027

First Submitted

Initial submission to the registry

November 13, 2025

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 14, 2025

Completed
2 months until next milestone

Study Start

First participant enrolled

January 2, 2026

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 30, 2027

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2027

Last Updated

February 11, 2026

Status Verified

October 1, 2025

Enrollment Period

1.2 years

First QC Date

November 13, 2025

Last Update Submit

February 9, 2026

Conditions

Skin Massage

Keywords

MassageEarly lifedermatologyImmune SystemImmune ResponseInfant DevelopmentSkin barrierMicrobiomeInterstitial Skin fluid

Outcome Measures

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.

    8 weeks

Secondary Outcomes (4)

  • Detection of skin biology changes in ISF using genetic profiling (RNA sequencing) and proteomics.

    8 weeks

  • Detection of changes in barrier function

    8 weeks

  • To measure specific IgE to foods and aeroallergens

    8 weeks

  • To detect signals of skin microbiota e.g. bacterial diversity in addition to specific strains such as Staphylococci.

    8 weeks

Study Arms (3)

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

Other: Skin Massage with Product

Daily Massage with Product

EXPERIMENTAL

Application of product containing oil- and aqueous-based components + skin massage daily

Other: Skin Massage with Product

Interventions

Skin Massage with ProductOTHER

Application of product containing oil- and aqueous-based components to baby's skin followed by a standardized massage.

Daily Massage with ProductTwice-Weekly Massage with Product

Eligibility Criteria

Age0 Months - 6 Months
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

St. Thomas' Hospital

London, SE1 7EH, United Kingdom

RECRUITING

MeSH Terms

Interventions

Pharmaceutical Preparations

Study Officials

  • Carsten Flohr

    Guy's and St Thomas' NHS Foundation Trust

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Preeti Khurana

CONTACT

020 7188 7188gstt.cutie.study@nhs.net

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 13, 2025

First Posted

November 14, 2025

Study Start

January 2, 2026

Primary Completion (Estimated)

March 30, 2027

Study Completion (Estimated)

April 30, 2027

Last Updated

February 11, 2026

Record last verified: 2025-10

Locations

GB(1)