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Efficacy of emollient, anti-inflammatory cream contining Isoleucine vs. standard emollient cream in children with facial atopic dermatitis


- candidate number15168
- NTR NumberNTR4084
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR21-jul-2013
- Secondary IDsN/A 
- Public TitleEfficacy of emollient, anti-inflammatory cream contining Isoleucine vs. standard emollient cream in children with facial atopic dermatitis
- Scientific TitleEfficacy of emollient, anti-inflammatory cream contining Isoleucine vs. standard emollient cream in children with facial atopic dermatitis (AD) with evaluation of facial EASI score
- ACRONYMN/A
- hypothesisIsoleucine is an aminoacid showing in vitro efficacy in increasing keratinocytes to increase the production of Antimicrobial peptides (AMP)such as beta defensine. In AD there is a reduced production of AMP
- Healt Condition(s) or Problem(s) studiedAtopic Eczema Dermatitis Syndrome, AEDS, Children
- Inclusion criteriaChildren aged 1-12 years
Atopic Dermatitis mild to moderate
Presence of lesions on the Face
- Exclusion criteriaSevere AD
Treatment with systemic anti-inflammatory drugs
- mec approval receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingSingle
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-sep-2013
- planned closingdate30-jan-2014
- Target number of participants80
- InterventionsCream containing rhamnosoft, niacinamide and Isoleucine
Standard emollient cream (glycerol)
- Primary outcomeEASI score (eczema, itch, infiltration,escoriation)
- Secondary outcomeInvestigator global assessement
- TimepointsEvaliation of EASI score (facial) at baseline
3 weeks
6 weeks (end of treatment)
- Trial web siteNA
- statusplanned
- CONTACT FOR PUBLIC QUERIESMD. Massimo Milani
- CONTACT for SCIENTIFIC QUERIESMD. Massimo Milani
- Sponsor/Initiator Investigator initiated trial ( IIT )
- Funding
(Source(s) of Monetary or Material Support)
Investigator initiated trial ( IIT )
- PublicationsN/A
- Brief summaryThe hypotesis is that a cream containing rhamnosoft, nuiacinamide and isoleucine could be more efficacious.
- Main changes (audit trail)
- RECORD21-jul-2013 - 1-aug-2013


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