Moisturizer to Prevent Atopic Dermatitis (ACE-AD)
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ClinicalTrials.gov Identifier: NCT03808532 |
Recruitment Status :
Withdrawn
(Lack of funding)
First Posted : January 17, 2019
Last Update Posted : January 15, 2021
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Dermatitis, Atopic | Other: Cura+ Moisturizing Cream | Phase 2 |
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 |

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 |
- 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
- 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
- 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
- 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
- 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.
- 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.
- 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.

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Ages Eligible for Study: | up to 120 Hours (Child) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
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

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
Principal Investigator: | Elena Fridman, MD | Assuta Ashdod Hospital |
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 |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Dermatitis, Atopic Dermatitis Skin Diseases Skin Diseases, Genetic Genetic Diseases, Inborn |
Skin Diseases, Eczematous Hypersensitivity, Immediate Hypersensitivity Immune System Diseases |