Moisturizer to Prevent Atopic Dermatitis (ACE-AD)

MyOR

Status and phase: Withdrawn; Phase 2

Conditions: Dermatitis, Atopic

Treatments: Other: Cura+ Moisturizing Cream

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03808532

MYOR

Details and patient eligibility

About

Atopic dermatitis (AD) is a chronic, relapsing inflammatory skin disorder associated with a decreased ability of the skin to function as an efficient immunological barrier. The disease is now two to three times more prevalent in children than it was just four decades ago. It is manifested by eczematous skin lesions associated with severe itch, leading to a significant impairment in quality of life. Of additional importance, AD oftentimes progresses to allergic rhinitis and/or asthma, a process referred to as the "atopic march." Recent reports have indicated that daily application of moisturizing creams on neonates and infants can prevent the occurrence of AD and subsequently food allergies. This is postulated to be the outcome of restoring the barrier integrity of the skin through the daily application of moisturizer.

Sex: All

Ages: 24 to 120 hours old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. A healthy newborn delivered in a hospital setting more than 24 hours prior to enrollment & less than 120 hours prior to enrollment
2. Average forearm TEWL reading of >8.50 g/m2
3. Mothers must be aged >18 years
4. Parents' ability to complete questionnaire(s) at defined times throughout study duration
5. Parents or legal guardian provide informed written consent

Exclusion criteria

1. Preterm birth (birth prior to 37 weeks gestation)
2. Neonate has undergone major surgery or intends to undergo major surgery in the coming 14 days
3. Neonate has an existing widespread skin condition that would make the detection and/or assessment of eczema difficult
4. Neonate has been administered oral or parenteral antibiotics from birth until study enrollment
5. Neonate has a serious health issue which, at parent or investigator discretion, would make it difficult for the neonate or parents to take part in the trial
6. Any conditions which precludes the daily application of moisturizing lotion
7. Any other reason that, in the opinion of the investigator, prevents the subject from participating in the study or compromise the patient safety

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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0 participants in 2 patient groups

High-Risk with Moisturizer

Experimental group

Treatment:

Other: Cura+ Moisturizing Cream

High-Risk without Moisturizer

No Intervention group