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:
King's College London
Organization:
Study Overview
Official Title:
A Randomised Controlled Trial to Investigate How Regular Skin Massage Impacts the Immune System in Early Life
Status:
NOT_YET_RECRUITING
Status Verified Date:
2025-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CUTIE
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. 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.
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. 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.
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.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| CF-2021-2\108 | OTHER_GRANT | RoseTrees Trust and Stoneygate Trust | View |