Atopic EczemaSOFTERNCT03270566
Softened Water for Eczema Prevention Pilot Trial
A study testing Domestic ion-exchange water softener in people with Atopic Eczema, run by King's College London at 1 site in United Kingdom.
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 Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Atopic Eczema
- What is being tested?
- Domestic ion-exchange water softener
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 12 Feb 2018to Jun 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
St Thomas' Hospital
London, SE1 7EH
Zarif Jabbar-Lopez, MPH MRCP, 02071887188 ext. 57716, zarif.jabbar-lopez@kcl.ac.uk
About this study
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
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
Read the 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.
- Conditions
- Atopic Eczema
- Being tested
- Domestic ion-exchange water softener
- Keywords
- Water hardness, Atopic eczema prevention, Skin barrier function, Skin microbiome
- Medical subject headings
- Dermatitis, Atopic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Domestic ion-exchange water softenerDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Domestic ion-exchange water softener | Experimental | The intervention group will have a domestic ion-exchange water softener installed prior to birth. Receives: Device: Domestic ion-exchange water softener |
| Usual hard water supply | No intervention | The control group will receive their usual domestic water supply. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Before birth
Secondary outcomes (16)
Proportion of pregnant women approached who agree to be screened
Measured: Before birth
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)
Measured: Before birth
Proportion of families randomised that withdraw due to infant ineligibility
Measured: Baseline (birth)
Proportion of families in intervention arm who found the intervention acceptable
Measured: End of follow up (6 months of age)
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)
Measured: End of follow up (6 months of age)
Proportion of participants that have the water softening unit removed or disabled prior to end of follow up
Measured: End of follow up (6 months of age)
Proportion of participants with visible eczema status (yes/no) recorded
According to UK diagnostic criteria-based photographic protocol
Measured: Baseline, 4 weeks, 3 and 6 months
Proportion of water samples with hardness >20 mg/L calcium carbonate
Would suggest failure of the water softening device
Measured: Between installation and end of follow up
Proportion of participants that withdraw from the trial prior to end of follow up
Measured: From randomisation until end of follow up
Median number of nights spent away from the participant's main home during follow up
Measured: From birth until end of follow up (6 months of age)
Proportion of clinical outcome assessments that have remained blinded
Measured: at 4 weeks, 3 & 6 months
Proportion with patient-reported, doctor-diagnosed eczema
Measured: by 6 months of age
Proportion with visible eczema according to the UK diagnostic criteria-based photographic protocol
Measured: 4 weeks, 3 & 6 months
Severity of eczema (if present) using Eczema Area and Severity Index (EASI)
Measured: 4 weeks, 3 & 6 months
Patient-reported eczema symptoms (Patient-Orientated Eczema Measure - POEM)
Measured: Monthly from 4 weeks to 6 months of age
Time to onset of patient-reported doctor-diagnosed eczema
Measured: from birth to end of follow up (6 months of age)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2017
- Study start12 Feb 2018
- Primary completionJun 2019 (estimated)
- Study completionJun 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Atopic EczemaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- King's College London
- Sponsor type
- University, hospital or other
- Collaborators
- Guy's and St Thomas' NHS Foundation Trust, University of Nottingham, University of Sheffield, Imperial College London, University of Amsterdam, University of Dundee
- Responsible party
- Sponsor
- Investigators
- Carsten Flohr, PhD, FRCPCH, Principal investigator, King's College London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03270566
- Sponsor's protocol ID
- IRAS 233005
- Acronym
- SOFTER
- Status last verified
- Aug 2017
- First submitted
- 31 Aug 2017
- Last updated
- 19 Feb 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No plans to share IPD
Publications
Broderick C, Poulsen CS, Hjelmso MH, Marrs T, Radulovic S, Logan K, Li X, Wu Z, Sorensen SJ, Ezzamouri B, Alexander H, Fyhrquist N, Alenius H, Bhattacharyya M, Neumann AU, Lack G, Perkin M, Bonnelykke K, Stokholm J, Flohr C. Associations between early-life exposures and the infant skin microbiome. Br J Dermatol. 2026 Apr 17;194(5):923-934. doi: 10.1093/bjd/ljaf524.
PubMed 41542943Jabbar-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.
PubMed 34854157Laughter 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.
PubMed 33006135Jabbar-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.
PubMed 31434765
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03270566
- Acronym / sponsor ID
- SOFTER / IRAS 233005
- Conditions
- Atopic Eczema
- Keywords
- Water hardness, Atopic eczema prevention, Skin barrier function, Skin microbiome
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- King's College LondonUniversity, hospital or other
- Collaborators
- Guy's and St Thomas' NHS Foundation Trust, University of Nottingham, University of Sheffield, Imperial College London, University of Amsterdam, University of Dundee
- Study start
- 12 Feb 2018 (actual)
- Primary completion
- Jun 2019 (estimated)
- Study completion
- Jun 2019 (estimated)
- First posted
- 1 Sep 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Domestic ion-exchange water softener | Experimental | Device: Domestic ion-exchange water softenerThe intervention group will have a domestic ion-exchange water softener installed prior to birth. |
| Usual hard water supply | No intervention | –The control group will receive their usual domestic water supply. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Domestic ion-exchange water softenerIon-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. | Device | Domestic ion-exchange water softener |
Primary outcome
Proportion of eligible families screened who are willing and able to be randomised.
Time frame: Before birth
This is key to the determination of the likely success of a future, large-scale definitive randomised controlled trial (RCT).
16 secondary outcomes
Proportion of pregnant women approached who agree to be screened
Time frame: Before birth
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
Proportion of families randomised that withdraw due to infant ineligibility
Time frame: Baseline (birth)
Proportion of families in intervention arm who found the intervention acceptable
Time frame: End of follow up (6 months of age)
Proportion of participants in control arm that become exposed to softened water
Time frame: End of follow up (6 months of age)
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)
Proportion of participants with visible eczema status (yes/no) recorded
Time frame: Baseline, 4 weeks, 3 and 6 months
Proportion of water samples with hardness >20 mg/L calcium carbonate
Time frame: Between installation and end of follow up
Proportion of participants that withdraw from the trial prior to end of follow up
Time frame: From randomisation until end of follow up
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)
Proportion of clinical outcome assessments that have remained blinded
Time frame: at 4 weeks, 3 & 6 months
Proportion with patient-reported, doctor-diagnosed eczema
Time frame: by 6 months of age
Proportion with visible eczema according to the UK diagnostic criteria-based photographic protocol
Time frame: 4 weeks, 3 & 6 months
Severity of eczema (if present) using Eczema Area and Severity Index (EASI)
Time frame: 4 weeks, 3 & 6 months
Patient-reported eczema symptoms (Patient-Orientated Eczema Measure - POEM)
Time frame: Monthly from 4 weeks to 6 months of age
Time to onset of patient-reported doctor-diagnosed eczema
Time frame: from birth to end of follow up (6 months of age)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Feb 2018.
- Derived from this study: PubMed 41542943Broderick C, Poulsen CS, Hjelmso MH, Marrs T, Radulovic S, Logan K, Li X, Wu Z, Sorensen SJ, Ezzamouri B, Alexander H, Fyhrquist N, Alenius H, Bhattacharyya M, Neumann AU, Lack G, Perkin M, Bonnelykke K, Stokholm J, Flohr C. Associations between early-life exposures and the infant skin microbiome. Br J Dermatol. 2026 Apr 17;194(5):923-934. doi: 10.1093/bjd/ljaf524.
- Derived from this study: PubMed 34854157Jabbar-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.
- Derived from this study: PubMed 33006135Laughter 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.
- Derived from this study: PubMed 31434765Jabbar-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.
- Individual participant dataSharing planned: No. No plans to share IPD
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Carsten Flohr, PhD, FRCPCH principal investigator
King's College London
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Domestic ion-exchange water softener in people with Atopic Eczema, run by King's College London at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Zarif Jabbar-Lopez, MPH, MRCP (020 7188 7188 ext. 57716, zarif.jabbar-lopez@kcl.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of eligible families screened who are willing and able to be randomised. (time frame: Before birth). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03270566, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Feb 2018.