Psoriatic skin
Conditions
Interventions
Trade Name: DAIVONEX
Product Name: DAIVONEX
Pharmaceutical Form: Cream
Pharmaceutical form of the placebo: Cream
Route of administration of the placebo: Topical use (Noncurrent)
Sponsors
CLINICA DERMATOLOGICA POLICLINICO UMBERTO I "SAPIENZA"
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: -Males and females aged between 18 and 65 years -Psoriasis with mild to moderate involvement of the body surface less than 50% -Written informed consent Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 40 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: -Use of topical vitamin D in the last six months -Systemic use of vitamin D in the last six months -Use of traditional or biological systemic therapies in the last six months -Fertile patients that don't make use of safe contraceptives methods -Pregnancy and/or lactation -Participation in other clinical trials in the last six months -Alcoholism -Drug dependence -Poor compliance
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Role of Vitamin D in maintaining the integrity of epidermal barrier in psoriatic skin;Secondary Objective: Not applicable;Primary end point(s): Evaluate the possible role of vitamin D in maintaining the integrity of epidermal barrier in psoriatic skin;Timepoint(s) of evaluation of this end point: 60 days | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Evaluate the ability of vitamin D analogs to modify the expression of receptors ( VDR,TLRs ), the production of antimicrobial peptides, the expression and localizzation of junctional proteins.;Timepoint(s) of evaluation of this end point: 60 days | — |
Countries
Italy
Contacts
Public ContactStefano Calvieri
Stefano Calvieri
Outcome results
None listed