search
Back to results

Softened Water for Eczema Prevention Pilot Trial (SOFTER)

Primary Purpose

Atopic Eczema

Status
Unknown status
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Domestic ion-exchange water softener
Sponsored by
King's College London
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Atopic Eczema focused on measuring Water hardness, Atopic eczema prevention, Skin barrier function, Skin microbiome

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • St Thomas' HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Domestic ion-exchange water softener

Usual hard water supply

Arm Description

The intervention group will have a domestic ion-exchange water softener installed prior to birth.

The control group will receive their usual domestic water supply.

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

Proportion of pregnant women approached who agree to be screened
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)
Proportion of families randomised that withdraw due to infant ineligibility
Proportion of families in intervention arm who found the intervention acceptable
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)
Proportion of participants that have the water softening unit removed or disabled prior to end of follow up
Proportion of participants with visible eczema status (yes/no) recorded
According to UK diagnostic criteria-based photographic protocol
Proportion of water samples with hardness >20 mg/L calcium carbonate
Would suggest failure of the water softening device
Proportion of participants that withdraw from the trial prior to end of follow up
Median number of nights spent away from the participant's main home during follow up
Proportion of clinical outcome assessments that have remained blinded
Proportion with patient-reported, doctor-diagnosed eczema
Proportion with visible eczema according to the UK diagnostic criteria-based photographic protocol
Severity of eczema (if present) using Eczema Area and Severity Index (EASI)
Patient-reported eczema symptoms (Patient-Orientated Eczema Measure - POEM)
Time to onset of patient-reported doctor-diagnosed eczema

Full Information

First Posted
August 31, 2017
Last Updated
February 15, 2018
Sponsor
King's College London
Collaborators
Guy's and St Thomas' NHS Foundation Trust, University of Nottingham, University of Sheffield, Imperial College London, University of Amsterdam, University of Dundee
search

1. Study Identification

Unique Protocol Identification Number
NCT03270566
Brief Title
Softened Water for Eczema Prevention Pilot Trial
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2017
Overall Recruitment Status
Unknown status
Study Start Date
February 12, 2018 (Actual)
Primary Completion Date
June 2019 (Anticipated)
Study Completion Date
June 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
King's College London
Collaborators
Guy's and St Thomas' NHS Foundation Trust, University of Nottingham, University of Sheffield, Imperial College London, University of Amsterdam, University of Dundee

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atopic Eczema
Keywords
Water hardness, Atopic eczema prevention, Skin barrier function, Skin microbiome

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Domestic ion-exchange water softener
Arm Type
Experimental
Arm Description
The intervention group will have a domestic ion-exchange water softener installed prior to birth.
Arm Title
Usual hard water supply
Arm Type
No Intervention
Arm Description
The control group will receive their usual domestic water supply.
Intervention Type
Device
Intervention Name(s)
Domestic ion-exchange water softener
Intervention Description
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.
Primary Outcome Measure Information:
Title
Proportion of eligible families screened who are willing and able to be randomised.
Description
This is key to the determination of the likely success of a future, large-scale definitive randomised controlled trial (RCT).
Time Frame
Before birth
Secondary Outcome Measure Information:
Title
Proportion of pregnant women approached who agree to be screened
Time Frame
Before birth
Title
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)
Time Frame
Before birth
Title
Proportion of families randomised that withdraw due to infant ineligibility
Time Frame
Baseline (birth)
Title
Proportion of families in intervention arm who found the intervention acceptable
Time Frame
End of follow up (6 months of age)
Title
Proportion of participants in control arm that become exposed to softened water
Description
(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)
Time Frame
End of follow up (6 months of age)
Title
Proportion of participants that have the water softening unit removed or disabled prior to end of follow up
Time Frame
End of follow up (6 months of age)
Title
Proportion of participants with visible eczema status (yes/no) recorded
Description
According to UK diagnostic criteria-based photographic protocol
Time Frame
Baseline, 4 weeks, 3 and 6 months
Title
Proportion of water samples with hardness >20 mg/L calcium carbonate
Description
Would suggest failure of the water softening device
Time Frame
Between installation and end of follow up
Title
Proportion of participants that withdraw from the trial prior to end of follow up
Time Frame
From randomisation until end of follow up
Title
Median number of nights spent away from the participant's main home during follow up
Time Frame
From birth until end of follow up (6 months of age)
Title
Proportion of clinical outcome assessments that have remained blinded
Time Frame
at 4 weeks, 3 & 6 months
Title
Proportion with patient-reported, doctor-diagnosed eczema
Time Frame
by 6 months of age
Title
Proportion with visible eczema according to the UK diagnostic criteria-based photographic protocol
Time Frame
4 weeks, 3 & 6 months
Title
Severity of eczema (if present) using Eczema Area and Severity Index (EASI)
Time Frame
4 weeks, 3 & 6 months
Title
Patient-reported eczema symptoms (Patient-Orientated Eczema Measure - POEM)
Time Frame
Monthly from 4 weeks to 6 months of age
Title
Time to onset of patient-reported doctor-diagnosed eczema
Time Frame
from birth to end of follow up (6 months of age)
Other Pre-specified Outcome Measures:
Title
Transepidermal water loss (TEWL)
Time Frame
at birth, 4 weeks, 3 & 6 months oif age
Title
Cutaneous cytokine profiles
Description
e.g. interleukin-1 levels
Time Frame
at birth, 4 weeks, 3 & 6 months oif age
Title
Natural moisturising factor (NMF) levels
Time Frame
at birth, 4 weeks, 3 & 6 months oif age
Title
Shannon Diversity Index and other skin and respiratory microbiota parameters
Time Frame
at birth, 4 weeks, 3 & 6 months oif age
Title
Proportion with filaggrin null mutations
Time Frame
at birth, 4 weeks, 3 & 6 months oif age
Title
Effect of filaggrin (FLG) gene mutation status on TEWL, cytokine levels, NMF levels and skin microbiota diversity
Time Frame
at birth, 4 weeks, 3 & 6 months oif age
Title
Median domestic water hardness level (calcium carbonate concentration)
Time Frame
at birth, 4 weeks, 3 & 6 months oif age
Title
Skin hydration
Time Frame
at birth, 4 weeks, 3 & 6 months oif age

10. Eligibility

Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Zarif Jabbar-Lopez, MPH, MRCP
Phone
020 7188 7188
Ext
57716
Email
zarif.jabbar-lopez@kcl.ac.uk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Carsten Flohr, PhD, FRCPCH
Organizational Affiliation
King's College London
Official's Role
Principal Investigator
Facility Information:
Facility Name
St Thomas' Hospital
City
London
ZIP/Postal Code
SE1 7EH
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zarif Jabbar-Lopez, MPH MRCP
Phone
02071887188
Ext
57716
Email
zarif.jabbar-lopez@kcl.ac.uk

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
No plans to share IPD
Citations:
PubMed Identifier
34854157
Citation
Jabbar-Lopez ZK, Ezzamouri B, Briley A, Greenblatt D, Gurung N, Chalmers JR, Thomas KS, Frost T, Kezic S, Common JEA, Danby S, Cork MJ, Peacock JL, Flohr C. Randomized controlled pilot trial with ion-exchange water softeners to prevent eczema (SOFTER trial). Clin Exp Allergy. 2022 Mar;52(3):405-415. doi: 10.1111/cea.14071. Epub 2021 Dec 12.
Results Reference
derived
PubMed Identifier
33006135
Citation
Laughter MR, Maymone MBC, Mashayekhi S, Arents BWM, Karimkhani C, Langan SM, Dellavalle RP, Flohr C. The global burden of atopic dermatitis: lessons from the Global Burden of Disease Study 1990-2017. Br J Dermatol. 2021 Feb;184(2):304-309. doi: 10.1111/bjd.19580. Epub 2020 Nov 29.
Results Reference
derived
PubMed Identifier
31434765
Citation
Jabbar-Lopez ZK, Gurung N, Greenblatt D, Briley A, Chalmers JR, Thomas KS, Frost T, Kezic S, Common JEA, Kong HH, Segre JA, Danby S, Cork MJ, Peacock JL, Flohr C. Protocol for 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: the Softened Water for Eczema Prevention (SOFTER) trial. BMJ Open. 2019 Aug 20;9(8):e027168. doi: 10.1136/bmjopen-2018-027168.
Results Reference
derived

Learn more about this trial

Softened Water for Eczema Prevention Pilot Trial

We'll reach out to this number within 24 hrs