Moisturizer to Prevent Atopic Dermatitis (ACE-AD)

A Prospective Randomized Open-label Controlled Study to Assess Whether Daily Application of Skin Moisturizer Containing Acemannan Hydrogel From Birth Can Prevent Atopic Dermatitis in Children

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.

Study Overview

• Status: Withdrawn
• Conditions: Dermatitis, Atopic
• Intervention / Treatment: Other: Cura+ Moisturizing Cream

• Study Type: Interventional
• Phase: Phase 2

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 day to 5 days (Child)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: High-Risk with Moisturizer	Other: Cura+ Moisturizing Cream; Parents of at-risk infants in the intervention arm will be instructed to apply moisturizer to the infant's entire body once daily for six months.
No Intervention: High-Risk without Moisturizer

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cumulative incidence of AD at twelve months of age in the intervention group compared to the control	Evaluated using the UK refinement of the Hanifin and Rajka diagnostic criteria for atopic eczema and by parental report of a medical diagnosis of AD by the infant's pediatrician and/or dermatologist	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cumulative incidence of AD at six months of age in the intervention group compared to the control	Evaluated using the UK refinement of the Hanifin and Rajka diagnostic criteria for atopic eczema and by parental report of a medical diagnosis of AD by the infant's pediatrician and/or dermatologist	6 months
Cumulative incidence of AD at 24 months of age in the intervention group compared to the control	Evaluated using the UK refinement of the Hanifin and Rajka diagnostic criteria for atopic eczema and by parental report of a medical diagnosis of AD by the infant's pediatrician and/or dermatologist	24 months
Timing of onset of AD in the intervention group compared to the control	Evaluated using the UK refinement of the Hanifin and Rajka diagnostic criteria for atopic eczema and by parental report of a medical diagnosis of AD by the infant's pediatrician and/or dermatologist	12 months
Severity of AD in the intervention group compared to the control	Assessed using the Patient-Oriented Eczema Measure (POEM) questionnaire and accompanying scoring criteria. Additionally, it will be assessed by parental report of first steroidal indication by physician.	12 months
Cumulative incidence of food allergies at 12 months of age in the intervention group compared to the control	Evaluated with the 2010 U.S. Food and Drug Administration Food Safety Survey Questionnaire.	12 months
Cumulative incidence of food allergies at 24 months of age in the intervention group compared to the control	Evaluated with the 2010 U.S. Food and Drug Administration Food Safety Survey Questionnaire.	24 months

Collaborators and Investigators

• Sponsor: MYOR Ltd.
• Collaborators: Assuta Ashdod Hospital
• Investigators: Principal Investigator: Elena Fridman, MD, Assuta Ashdod Hospital

Study record dates

Study Major Dates

• Study Start (Anticipated): June 1, 2020
• Primary Completion (Anticipated): December 1, 2021
• Study Completion (Anticipated): December 1, 2022

Study Registration Dates

• First Submitted: January 2, 2019
• First Submitted That Met QC Criteria: January 15, 2019
• First Posted (Actual): January 17, 2019

Study Record Updates

• Last Update Posted (Actual): January 15, 2021
• Last Update Submitted That Met QC Criteria: January 13, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Immune System Diseases; Hypersensitivity, Immediate; Genetic Diseases, Inborn; Skin Diseases, Genetic; Hypersensitivity; Skin Diseases, Eczematous; Dermatitis; Dermatitis, Atopic
• Other Study ID Numbers: MYOR

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No