Moisturizer to Prevent Atopic Dermatitis

NCT ID: NCT03808532

Last Updated: 2021-01-15

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE2
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-06-30
• Study Completion Date: 2022-12-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

High-Risk with Moisturizer

Group Type: EXPERIMENTAL

Cura+ Moisturizing Cream

Intervention Type: 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 without Moisturizer

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: OTHER

Eligibility 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

• Minimum Eligible Age: 24 Hours
• Maximum Eligible Age: 120 Hours
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Assuta Ashdod Hospital

OTHER

Sponsor Role: collaborator

MYOR Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Elena Fridman, MD

Role: PRINCIPAL_INVESTIGATOR

Assuta Ashdod Hospital

Other Identifiers

MYOR

Identifier Type: -

Identifier Source: org_study_id