Please select the eligibility criteria that correspond to the clinical trial below.
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
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


Options:
A: Inclusion Criteria:

* Patients with atopic dermatitis (Hanifin and Rajka criteria),
* Aged 15 years or more,
* With \> 2 years of disease evolution,
* With moderate-to-severe disease (IGA \> 2),
* Patients that have received TAT for at least 12 weeks and have symptoms requiring an increase in therapy,
* Seasonality in disease severity (based on a questionnaire assessing disease improvement during summer),
* Easy access to a phototherapy cabin (widely implanted in primary care dermatology private practice in France),
* Effective contraception to be used at least 30 days before initiation of treatment, during treatment and 29 weeks after last administration for women of reproductive age,
* Written informed consent of the patient
* For patients aged between 15 and 18, written informed consent of the parents and of the teenager.

Exclusion Criteria:

* Any cause of contra-indication for vitamin D supplementation: flare of granulomatosis, primary hyperparathyroidism,
* Clinical suspicion of hypercalciuria,
* Indication to a systemic immunosuppressant in the next 2 years,
* Atopic dermatitis known to be aggravated by UV exposure,
* Any contra-indication for artificial or solar exposure including: genetic diseases with a predisposition to skin cancer, any history of personal skin cancer (melanoma, squamous cell skin cancer, basal cell skin cancer), lupus, dermatomyositis, any other photosensitizing skin disease, photosensitizing medication (see appendix 2),
* More than 100 previous phototherapy sessions in lifetime,
* Pregnancy or breastfeeding,
* Persons subject to major legal protection (safeguarding justice, guardianship, trusteeship), persons deprived of liberty.
B: Inclusion Criteria:

* Patients with chronic AD (Hanifin and Rajka, 1980); moderate to severe disease with SCORAD-index \> 30 (maximum = 102).
* Age \> 18 years
* No topical steroids (except 1% hydrocortisone) or topical/systemic antibiotics or antihistamines within the last 2 weeks, no systemic glucocorticosteroids or other immunosuppressive agents within the last 8 weeks, no phototherapy within the last 12 weeks before inclusion

Exclusion Criteria:

* Pregnancy or lactation
* Skin cancer or dysplastic naevi, photosensitive skin diseases, autoimmune diseases or relevant cardiovascular diseases
* Photo-skin type I according to Fitzpatrick
C: 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
D: Inclusion Criteria:

* Signed and dated informed consent prior to any study mandated procedure
* Good health as determined by the Investigator
* Willing and able to comply with study requirements
* Atopic dermatitis (AD) fulfilling the United Kingdom (UK) criteria of AD
* Age between 18 and ≤ 75 years
* Reliable method of contraception for women of childbearing potential (i.e. low failure rate less than 1% per year; e.g. oral contraceptives, intrauterine device \[IUD\] or transdermal contraceptive patch)
* Willing to abstain from excessive sun / UV exposure (e.g. sunbathe, solarium) during the course of the study
* Body Mass Index ≥ 18 and ≤ 35

Exclusion Criteria:

General

* Inmates of psychiatric wards, prisons, or other state institutions
* Investigator or any other team member involved directly or indirectly in the conduct of the clinical study
* Participation in another clinical trial within the last 30 days
* Pregnant or nursing women
* Risk of non-compliance with study procedures

Medical History

* Past or present disease, which as judged by the investigator, may affect the outcome of this study. These diseases may include cardiovascular disease, malignancy, hepatic disease, renal disease, hematological disease, neurological disease, endocrine disease or pulmonary disease, and others.
* Clinically relevant abnormalities in hematology, or blood chemistry at screening.
* Positive HIV-1/2Ab, hepatitis B surface antigen (HBsAg) or hepatitis C virus antibodies (HCV-Ab) test at screening.
* Diastolic blood pressure above 95 mmHg.
* Febrile illness within 2 weeks prior to baseline visit.
* Alcohol or drug abuse within 12 months prior to screening (i.e., Regular daily consumption of more than 1 liter of beer or the equivalent quantity of approximately 40 g of alcohol in another form.)
* Photodermatosis and/or significant photosensitivity, including porphyria and/or hypersensitivity to porphyrins as well as photosensitivity due to present or past (within the last year) intake of amiodarone.
* Congenital or acquired immunodeficiency
* Patients who have been diagnosed with invasive skin cancer at any time (=malignant cells invaded below the basal membrane of the epidermis), or with severe actinic damage present at baseline visit.
* Patients with genetic deficiencies attached with increased sensitivity to light or increased risk to dermatologic cancer (i.e. Xeroderma pigmentosum, Cockayne Syndrome, Bloom-Syndrome).

Concomitant medication/treatment in medical history and during the study

Within 8 weeks prior to baseline visit:

* Systemic immunosuppression treatment (steroids, cyclosporine, azathioprine, Mycophenolate Mofetil (MMF))

Within 4 weeks prior to baseline visit:

* UV radiation treatment

Within 2 weeks prior to baseline visit:

* Topical steroid treatment
* Topical calcineurin inhibitor treatment

Within 3 days prior to baseline visit:

* Photo-sensitising medication (e.g. psoralen, tetracyclines, hydrochlorothiazide, phenothiazines, quinolones, hypericumperforatum, arnica, valerian, tar) as assessed by the regular medication plan of the patient
* colours (e.g. thiazide, toluidine blue, eosin, methylene blue, rose Bengal, acridine) which will be visible on the patient's skin

Answer: C