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Evaluation of efficacy of topical corticosteroid once daily plus emollient cream once daily vs. topical corticosteroid cream twice daily alone in chronique plaque psoriasis


- candidate number15109
- NTR NumberNTR4068
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR10-jul-2013
- Secondary IDs01-2013 Nutra
- Public TitleEvaluation of efficacy of topical corticosteroid once daily plus emollient cream once daily vs. topical corticosteroid cream twice daily alone in chronique plaque psoriasis
- Scientific TitleEvaluation of efficacy of topical corticosteroid plus emollient cream vs. topical corticosteroid cream alone in chronique plaque psoriasis. A randomised paralell gropu study
- ACRONYMN/A
- hypothesisTo evaluate if topical corticosteroid plus emollient cream is efficacious as topical corticosteroid applied twice daily in mild to moderate plaque psoriasis
- Healt Condition(s) or Problem(s) studiedChronic plaque psoriasis
- Inclusion criteriaMen and women aged 18 years or more Plaque psoriasis mild to moderate
- Exclusion criteriaSevere plaque psoriasis
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingSingle
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-aug-2013
- planned closingdate1-jan-2014
- Target number of participants30
- InterventionsInvestigational compound : non-steroideal, anti-inflammatory moisturizing cream containing rhamnosoft, ceramides and L-isoleucine (ILE) (Nutratopic Pro AMP) Comparator: emollient cream containing glycerol
Both topical products will be applied twice daily on the face (1 FTU/application) for a total of 6 weeks
- Primary outcomeFacial modified Eczema Area Severity Index (EASI) using a 4-scale score (from 0 to 3) (absent, mild, moderate, severe) evaluating: erythema, infiltration, lichenification, erosion
- Secondary outcomePhysician Global assessment (a 6-point scale) from 0 to 5; Tolerability will be evaluated at week 3 and at week 6 using a 4-point score (from 0: very good tolerability to 3: very poor tolerability)
- TimepointsThe primary outcome of the trial is the facial EASI score evaluated at baseline (time 0, after week 3, and finally at week 6). The secondary endpoints are the Physician Global assessment which will be evaluated at week 6 (end of treatment) and the Tolerability score which will be evaluated at week 3 and 6.
Both outcomes would be evaluated during the study visits (week 0, week 3 and week 6) performed in the morning and evaluated by an assessor unaware of treatment allocation.
- Trial web siteNA
- status[default]
- 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 summaryAtopic eczema (AE) is a very common skin condition in pediatric population. Skin barrier alteration and reduction of innate immune mechanisms (low production of anti-microbial peptides: AMP) are considered the hallmarks of AE. Face is frequently affected in AE representing a therapeutic challenge. A non-steroideal, anti-inflammatory moisturizing cream containing rhamnosoft, ceramides and L-isoleucine (ILE) has been recently developed for the specific treatment of AE of the face. Topical ILE has shown to stimulate a skin level the production of AMP. Niacinamide has shown to improve skin barrier. Ceramides also can reinforce the skin barrier functions in AD patients. Therefore this topical formulation has a strong rational for the use in AD subjects. In this trial we want evaluate the clinical efficacy and tolerability of a rhamnosoft, ceramides and ILE containing cream (pro-AMP cream) in the treatment of facial atopic eczema in children in comparison with a simple hydrating cream.
- Main changes (audit trail)
- RECORD10-jul-2013 - 24-jul-2013


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