No registrations found.
ID
Source
Brief title
Health condition
Chronic Plaque psoriasis
Sponsors and support
Prog Giuseppe Micali
Clinica Dermatologica
University Catania (Italy)
Intervention
Outcome measures
Primary outcome
Facial 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 outcome
Physician 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)
Background summary
Atopic 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.
Study objective
To evaluate if topical corticosteroid plus emollient cream is efficacious as topical corticosteroid applied twice daily in mild to moderate plaque psoriasis
Study design
The 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.
Intervention
Investigational 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
Inclusion criteria
Men and women aged 18 years or more
Plaque psoriasis mild to moderate
Exclusion criteria
Severe plaque psoriasis
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL3930 |
| NTR-old | NTR4068 |
| Other | Nutra : 01-2013 |
| ISRCTN | ISRCTN wordt niet meer aangevraagd. |