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Moisturizer to Prevent Atopic Dermatitis (ACE-AD)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03808532
Recruitment Status : Withdrawn (Lack of funding)
First Posted : January 17, 2019
Last Update Posted : January 15, 2021
Sponsor:
Collaborator:
Assuta Ashdod Hospital
Information provided by (Responsible Party):
MYOR Ltd.

Study Description
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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.

Condition or disease Intervention/treatment Phase
Dermatitis, Atopic Other: Cura+ Moisturizing Cream Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
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
Estimated Study Start Date : June 2020
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : December 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eczema

Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. Cumulative incidence of AD at twelve months of age in the intervention group compared to the control [ Time Frame: 12 months ]
    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 :
  1. Cumulative incidence of AD at six months of age in the intervention group compared to the control [ Time Frame: 6 months ]
    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

  2. Cumulative incidence of AD at 24 months of age in the intervention group compared to the control [ Time Frame: 24 months ]
    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

  3. Timing of onset of AD in the intervention group compared to the control [ Time Frame: 12 months ]
    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

  4. Severity of AD in the intervention group compared to the control [ Time Frame: 12 months ]
    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.

  5. Cumulative incidence of food allergies at 12 months of age in the intervention group compared to the control [ Time Frame: 12 months ]
    Evaluated with the 2010 U.S. Food and Drug Administration Food Safety Survey Questionnaire.

  6. Cumulative incidence of food allergies at 24 months of age in the intervention group compared to the control [ Time Frame: 24 months ]
    Evaluated with the 2010 U.S. Food and Drug Administration Food Safety Survey Questionnaire.


Eligibility Criteria
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Ages Eligible for Study:   24 Hours to 120 Hours   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03808532


Sponsors and Collaborators
MYOR Ltd.
Assuta Ashdod Hospital
Investigators
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Principal Investigator: Elena Fridman, MD Assuta Ashdod Hospital
More Information
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Responsible Party: MYOR Ltd.
ClinicalTrials.gov Identifier: NCT03808532    
Other Study ID Numbers: MYOR
First Posted: January 17, 2019    Key Record Dates
Last Update Posted: January 15, 2021
Last Verified: January 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Dermatitis, Atopic
Dermatitis
Skin Diseases
Skin Diseases, Genetic
Genetic Diseases, Inborn
 Skin Diseases, Eczematous
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases