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NCT03808532: ACE-AD
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
Phase 2 trial testing Cura+ Moisturizing Cream in Dermatitis, Atopic. Withdrawn.
1 December 2021
Quick facts
| Lead sponsor | MYOR Ltd. |
|---|---|
| Phase | Phase 2 |
| Status | Withdrawn |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | single |
| Primary purpose | prevention |
| Start date | 1 June 2020 |
| Primary completion | 1 December 2021 |
| Estimated completion | 1 December 2022 |
Drugs / interventions tested
- Cura+ Moisturizing Cream
Conditions studied
- Dermatitis, Atopic — all drugs for Dermatitis, Atopic →
Sponsor
MYOR Ltd.
Who can join
Adults 24 Hours to 120 Hours, any sex, with Dermatitis, Atopic. Healthy volunteers can join.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
-
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
Sponsor's own description
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.
Publications & conference data
2 peer-reviewed publications reference this trial (live from Europe PMC):
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Skin care interventions in infants for preventing eczema and food allergy.
Kelleher MM, Cro S, Cornelius V, Lodrup Carlsen KC, et al · · 2021 · cited 43× · PMID 33545739 · DOI 10.1002/14651858.cd013534.pub2 -
Skin care interventions in infants for preventing eczema and food allergy.
Kelleher MM, Phillips R, Brown SJ, Cro S, et al · · 2022 · cited 29× · PMID 36373988 · DOI 10.1002/14651858.cd013534.pub3
Verify or expand the search:
- PubMed search for NCT03808532
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Dermatitis, Atopic
Currently open trials in the same condition.
- NCT07230860 — A Study of JNJ-95597528 in Participants With Moderate to Severe Atopic Dermatitis · Phase 2 · recruiting
- NCT06899204 — Real World Efficiency of Abrocitinib Treatment at Patients With Moderate to Severe Atopic Dermatitis Who Had Inadequate · recruiting
- NCT07042126 — Evaluation of 611 in Chinese Adolescents With Moderate to Severe Atopic Dermatitis · Phase 3 · recruiting
- NCT06881251 — A Study of JNJ-95475939 in the Treatment of Participants With Moderate to Severe Atopic Dermatitis (AD) · Phase 2 · active not recruiting
- NCT06554847 — Evaluation of 611 in Combination With Topical Corticosteroid in Participants With Moderate to Severe Atopic Dermatitis · Phase 3 · active not recruiting
Other MYOR Ltd. trials
Trials by the same sponsor.
- NCT04573244 — Hemoglobin Easy Measurement With Optical Artificial Intelligence · completed
- NCT04325451 — Comprehending Atopic Risk Elements · unknown
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT03808532 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by MYOR Ltd.
- Last refreshed: 13 January 2021
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03808532.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing