Exploring the Cutaneous Immune Response to Skin Massage in Early Life (CUTIE)

King's College London

Status: Not yet enrolling

Conditions: Skin Massage

Treatments: Other: Skin Massage with Product

Study type: Interventional

Funder types: Other

Identifiers

NCT07228728

173023

CF-2021-2\108 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 109 estimated patients

Sex: All

Ages: Under 6 months old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Healthy babies born at term up to 6 months old
2. Ability of parents/guardians/caregivers to provide written informed consent for study participation
3. Willingness of parents/guardians/caregivers to comply with all study requirements.

Exclusion criteria

1. Parents/guardians/caregivers unable to give informed consent.
2. Personal history of inflammatory skin disease (in particular atopic dermatitis)
3. Active involvement in another interventional research study

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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109 participants in 3 patient groups

No application of product and no massage

No Intervention group

Description:

No application of product and no massage.

Twice-Weekly Massage with Product

Experimental group

Description:

Application of product containing oil- and aqueous-based components + skin massage twice a week

Treatment:

Other: Skin Massage with Product

Daily Massage with Product

Experimental group

Description:

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

Treatment:

Other: Skin Massage with Product