Psoriasis MedDRA version: 20.0 Level: LLT Classification code 10050576 Term: Psoriasis vulgaris System Organ Class: 100000004858
Conditions
Interventions
Trade Name: ENSTILAR
Product Name: ENSTILAR
Pharmaceutical Form: Cutaneous foam
Pharmaceutical form of the placebo: Cutaneous foam
Route
Sponsors
CHU de Nice
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients of both more than 18-year-old sexes having signed and dated a form of information and informed consent. 2. Subject presenting a psoriasis vulgaris with symmetric hurts in size and in severity, located on elbows and\or knees and having a score of severity (PASI)=65 years) yes F.1.3.1 Number of subjects for this age range 2
Exclusion criteria
Exclusion criteria: 1. Subject presenting a psoriasis in drop(gout), érythrodermique, exfoliatif or pustuleux. 2. Feminine Subject pregnant or breast-feeding. 3. Subject having received a systematic treatment(processing) and having a potential action(share) on the psoriasis vulgaris (ex: phototherapy, cyclosporine, méthotrexate, biotherapics, steroids, or other immunosuppresseurs treatments(processings)) in 2 months preceding the randomization and during all the duration the study. 4. Subject having received a treatment(processing) antibiotic in the previous three months the visit of inclusion 5. Subject having received the topical treatments(processings) (example: corticostéroïdes, tazarotène, analogues of the vitamin D) or neutral emollients in 4 weeks preceding the randomization
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Compare the respective effects of the combination betamethasone-calcipotriol mousse: 1) Versus the placebo foam, 2) Versus betamethasone cream (DIPROSONE), 3) Versus the clobetasol propionate (DERMOVAL) cream, on the cutaneous microbiome of psoriasis lesions and surrounding healthy skin after 4 weeks of treatments ; Secondary Objective: 1. Evaluate the relative efficacy of the products on psoriasis lesions, 2. Assess tolerance and adverse effects, 3. Evaluate the impact of treatments on lymphoid innate cells (number and relative proportion in the 3 types of ILC) and natural killer cells (NKs) in lesions and their potential correlation with microbiome modification. ;Primary end point(s): Quantitative and qualitative evaluation of bacterial microbiota on psoriasis lesions and surrounding healthy skin by 16S rRNA amplification coupled with high throughput sequencing. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - PASI for the effectiveness of the products tested. - Number and types of ILCs and NKs on skin biopsies using immunohistochemistry - Overall evaluation of the investigator's treatment (PGA) after 4 weeks of treatment. - Evaluation of the tolerance after 4 weeks of treatment. - Study the occurrence of possible adverse effects | — |
Countries
France
Contacts
Public ContactDRCI
CHU de Nice
Outcome results
None listed