Moisturizer to Prevent Atopic Dermatitis

NCT03808532 | Withdrawn Phase 2

• 1 other identifier: MYOR
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Dermatitis, Atopic

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

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

  6 months

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

  24 months

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

  12 months

• Severity of AD in the intervention group compared to the control

  12 months

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

  12 months

Study Arms (2)

High-Risk with Moisturizer

EXPERIMENTAL

Other: Cura+ Moisturizing Cream

High-Risk without Moisturizer

NO INTERVENTION

Interventions

Cura+ Moisturizing Cream OTHER

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.

High-Risk with Moisturizer

Eligibility Criteria

• Age: 24 Hours - 120 Hours
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• MYOR Ltd.: lead
• Assuta Ashdod Hospital: collaborator

MeSH Terms

Conditions

Dermatitis, Atopic

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Elena Fridman, MD

  Assuta Ashdod Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 2, 2019
• First Posted: January 17, 2019
• Study Start: June 1, 2020
• Primary Completion: December 1, 2021
• Study Completion: December 1, 2022
• Last Updated: January 15, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share