Back to results

Moisturizer to Prevent Atopic Dermatitis (ACE-AD)

Primary Purpose

Dermatitis, Atopic

Status

Withdrawn

Phase

Phase 2

Locations

Study Type

Interventional

Intervention

Cura+ Moisturizing Cream

About this trial

This is an interventional prevention trial for Dermatitis, Atopic

Eligibility Criteria

24 Hours - 120 Hours (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

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

Exclusion Criteria:

Preterm birth (birth prior to 37 weeks gestation)
Neonate has undergone major surgery or intends to undergo major surgery in the coming 14 days
Neonate has an existing widespread skin condition that would make the detection and/or assessment of eczema difficult
Neonate has been administered oral or parenteral antibiotics from birth until study enrollment
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
Any conditions which precludes the daily application of moisturizing lotion
Any other reason that, in the opinion of the investigator, prevents the subject from participating in the study or compromise the patient safety

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

High-Risk with Moisturizer

High-Risk without Moisturizer

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

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

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

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.

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.

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.

Full Information

NCT ID

NCT03808532

First Posted

January 2, 2019

Last Updated

January 13, 2021

Sponsor

MYOR Ltd.

Collaborators

Assuta Ashdod Hospital

1. Study Identification

Unique Protocol Identification Number

NCT03808532

Brief Title

Moisturizer to Prevent Atopic Dermatitis

Acronym

ACE-AD

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2021

Overall Recruitment Status

Withdrawn

Why Stopped

Lack of funding

Study Start Date

June 2020 (Anticipated)

Primary Completion Date

December 2021 (Anticipated)

Study Completion Date

December 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

MYOR Ltd.

Collaborators

Assuta Ashdod Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Dermatitis, Atopic

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

High-Risk with Moisturizer

Arm Type

Experimental

Arm Title

High-Risk without Moisturizer

Arm Type

No Intervention

Intervention Type

Other

Intervention Name(s)

Cura+ Moisturizing Cream

Intervention Description

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.

Primary Outcome Measure Information:

Title

Cumulative incidence of AD at twelve months of age in the intervention group compared to the control

Description

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

Time Frame

12 months

Secondary Outcome Measure Information:

Title

Cumulative incidence of AD at six months of age in the intervention group compared to the control

Description

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

Time Frame

6 months

Title

Cumulative incidence of AD at 24 months of age in the intervention group compared to the control

Description

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

Time Frame

24 months

Title

Timing of onset of AD in the intervention group compared to the control

Description

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

Time Frame

12 months

Title

Severity of AD in the intervention group compared to the control

Description

Time Frame

12 months

Title

Cumulative incidence of food allergies at 12 months of age in the intervention group compared to the control

Description

Evaluated with the 2010 U.S. Food and Drug Administration Food Safety Survey Questionnaire.

Time Frame

12 months

Title

Cumulative incidence of food allergies at 24 months of age in the intervention group compared to the control

Description

Evaluated with the 2010 U.S. Food and Drug Administration Food Safety Survey Questionnaire.

Time Frame

24 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

24 Hours

Maximum Age & Unit of Time

120 Hours

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: A healthy newborn delivered in a hospital setting more than 24 hours prior to enrollment & less than 120 hours prior to enrollment Average forearm TEWL reading of >8.50 g/m2 Mothers must be aged >18 years Parents' ability to complete questionnaire(s) at defined times throughout study duration Parents or legal guardian provide informed written consent Exclusion Criteria: Preterm birth (birth prior to 37 weeks gestation) Neonate has undergone major surgery or intends to undergo major surgery in the coming 14 days Neonate has an existing widespread skin condition that would make the detection and/or assessment of eczema difficult Neonate has been administered oral or parenteral antibiotics from birth until study enrollment 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 Any conditions which precludes the daily application of moisturizing lotion Any other reason that, in the opinion of the investigator, prevents the subject from participating in the study or compromise the patient safety

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Elena Fridman, MD

Organizational Affiliation

Assuta Ashdod Hospital

Official's Role

Principal Investigator

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Moisturizer to Prevent Atopic Dermatitis

We'll reach out to this number within 24 hrs