Softened Water for Eczema Prevention Pilot Trial

Atopic Eczema Clinical Trial

— SOFTER  

Official title:

An Outcome Assessor-blinded Pilot Randomised Controlled Trial of an Ion-exchange Water Softener for the Prevention of Atopic Eczema in Neonates, With an Embedded Mechanistic Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03270566
• Other study ID #: IRAS 233005
• Status: Recruiting
• Phase: N/A
• First received: August 31, 2017
• Last updated: February 15, 2018
• Start date: February 12, 2018
• Est. completion date: June 2019

Study information

• Verified date: August 2017
• Source: King's College London
• Contact: Zarif Jabbar-Lopez, MPH, MRCP
• Phone: 020 7188 7188
• Email: zarif.jabbar-lopez[@]kcl.ac.uk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

An outcome assessor-blinded pilot randomised controlled trial of an ion-exchange water softener for the prevention of atopic eczema in neonates, with an embedded mechanistic study

Description:

A 6-month parallel group assessor-blinded pilot randomised controlled trial of an ion-exchange water softener for the prevention of eczema in neonates, with an embedded mechanistic study.

The overall rationale is that by installing a domestic water softener around the time of birth, the infant will be exposed to softened water rather than hard water for bathing and that this will be less irritating to the skin than hard water and so associated with a lower risk of eczema development. The primary objective is to determine the feasibility of conducting a subsequent definitive RCT that will investigate whether installation of a domestic water softener around the time of birth can prevent eczema in high-risk babies. The secondary objective is to explore the likely mechanisms by which water softeners might prevent eczema.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: June 2019
• Est. primary completion date: June 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Participant (i.e. the neonate) must have a parent or sibling with a history of doctor-diagnosed atopy (i.e. at least one of: eczema, asthma, hayfever)

• Mother aged =18 years of age at enrolment

• Baby <36 weeks gestation at screening

• Informed consent from the mother on behalf of the participant

• Mother has the ability to understand English

• Live in a hard water area (>250 mg/L Calcium Carbonate)

• Consent of landlord for installation on water softener (if appropriate)

• Occupy a property appropriate for installation of a water softener

Exclusion Criteria:

• Preterm birth (defined as birth prior to 37 weeks gestation)

• Significant inflammatory skin disease at birth not including seborrheic dermatitis ("cradle cap")

• Sibling (including twin) previously randomised to this trial. If multiple birth, the first child will be randomised into the trial.

• The child is to be fostered/adopted

• Any immunodeficiency disorder or severe genetic skin disorder

• Child has any other serious health issue which, at parent or investigator discretion, would make it difficult for the family to take part in the trial.

• Planned stays away from home for a continuous period of more than 2 weeks or a total of 1 month out of the 6 month follow up period

• Water softening or filtration device already installed

• Concurrent enrolment in any other skin-related intervention study

• Other medical condition that in the opinion of the CI could interfere with the conduct of the trial

Related Conditions & MeSH terms

• Atopic Eczema
• Dermatitis, Atopic
• Eczema

Intervention

Device:
• Domestic ion-exchange water softener
Ion-exchange water softeners exchange calcium and magnesium, amongst other divalent cations, for monovalent sodium cations using a polystyrene resin. The sodium ions come from sodium chloride (common salt). The salt needs to be topped up every 3-4 weeks and sufficient quantities of block salt will be supplied to participants. The water softener used in this study does not require electricity and has two cylinders of resin which are used alternately. A control valve alternates the flow between the two cylinders and ensures a constant supply of regenerated resin. Ion-exchange water softeners typically reduce downstream water hardness to close to zero.

Locations

Country	Name	City	State
United Kingdom	St Thomas' Hospital	London

Sponsors (7)

Lead Sponsor	Collaborator
King's College London	Guy's and St Thomas' NHS Foundation Trust, Imperial College London, University of Amsterdam, University of Dundee, University of Nottingham, University of Sheffield

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Transepidermal water loss (TEWL)		at birth, 4 weeks, 3 & 6 months oif age
Other	Cutaneous cytokine profiles	e.g. interleukin-1 levels	at birth, 4 weeks, 3 & 6 months oif age
Other	Natural moisturising factor (NMF) levels		at birth, 4 weeks, 3 & 6 months oif age
Other	Shannon Diversity Index and other skin and respiratory microbiota parameters		at birth, 4 weeks, 3 & 6 months oif age
Other	Proportion with filaggrin null mutations		at birth, 4 weeks, 3 & 6 months oif age
Other	Effect of filaggrin (FLG) gene mutation status on TEWL, cytokine levels, NMF levels and skin microbiota diversity		at birth, 4 weeks, 3 & 6 months oif age
Other	Median domestic water hardness level (calcium carbonate concentration)		at birth, 4 weeks, 3 & 6 months oif age
Other	Skin hydration		at birth, 4 weeks, 3 & 6 months oif age
Primary	Proportion of eligible families screened who are willing and able to be randomised.	This is key to the determination of the likely success of a future, large-scale definitive randomised controlled trial (RCT).	Before birth
Secondary	Proportion of pregnant women approached who agree to be screened		Before birth
Secondary	Proportion of families eligible on screening that cannot have a water softener installed (e.g. due to landlord or local authority refusal, technical (plumbing) reasons)		Before birth
Secondary	Proportion of families randomised that withdraw due to infant ineligibility		Baseline (birth)
Secondary	Proportion of families in intervention arm who found the intervention acceptable		End of follow up (6 months of age)
Secondary	Proportion of participants in control arm that become exposed to softened water	(e.g. by moving to a new home in a soft water area, or moving to a home with an active water softener installed, before the end of follow up)	End of follow up (6 months of age)
Secondary	Proportion of participants that have the water softening unit removed or disabled prior to end of follow up		End of follow up (6 months of age)
Secondary	Proportion of participants with visible eczema status (yes/no) recorded	According to UK diagnostic criteria-based photographic protocol	Baseline, 4 weeks, 3 and 6 months
Secondary	Proportion of water samples with hardness >20 mg/L calcium carbonate	Would suggest failure of the water softening device	Between installation and end of follow up
Secondary	Proportion of participants that withdraw from the trial prior to end of follow up		From randomisation until end of follow up
Secondary	Median number of nights spent away from the participant's main home during follow up		From birth until end of follow up (6 months of age)
Secondary	Proportion of clinical outcome assessments that have remained blinded		at 4 weeks, 3 & 6 months
Secondary	Proportion with patient-reported, doctor-diagnosed eczema		by 6 months of age
Secondary	Proportion with visible eczema according to the UK diagnostic criteria-based photographic protocol		4 weeks, 3 & 6 months
Secondary	Severity of eczema (if present) using Eczema Area and Severity Index (EASI)		4 weeks, 3 & 6 months
Secondary	Patient-reported eczema symptoms (Patient-Orientated Eczema Measure - POEM)		Monthly from 4 weeks to 6 months of age
Secondary	Time to onset of patient-reported doctor-diagnosed eczema		from birth to end of follow up (6 months of age)

External Links

•   Research group website