Patients suffering from psoriasis with at least two eligible psoriatic plaques on equivalent topographic areas (arms, legs or trunk) MedDRA version: 9.1 Level: LLT Classification code 10037153 Term: Psoriasis
Conditions
Interventions
Product Name: UR-1505 0.5% OINTMENT
Product Code: UR 1505
Pharmaceutical Form: Ointment
Product Name: UR-1505 2% OINTMENT
Product Code: UR 1505
Pharmaceutical Form: Ointment
Product Name: UR-1505 4%
Sponsors
PALAU PHARMA SA
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Sex: Male or female · - Age: older than 18 and less than 75 years. - Phototype: I to IV according to the Fitzpatrick scale. - Patient with at least two eligible psoriatic plaques on equivalent topographic areas (arms, legs or trunk), each of a prefered size of 2% but in all cases smaller than 5% of body surface area. - For woman with child-bearing potential: use of a known, effective means of contraception (contraceptive pills, intra-uterine contraceptive device, tromp phallop ligation, implants, ring or condom) for at least 12 weeks prior to the study, during the study and one month after the end of the study. - Subject being psychologically able to understand information and to give his/her consent. - Subject having given freely and expressly his/her informed consent, cooperative and aware of the necessity and duration of the controls so that perfect adhesion to the protocol established by Group DERMSCAN can be expected. - Subject affiliated to a health social security system. 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 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: - Subject with a loss of personal liberty, by administrative or judicial decision. - Minor or major with a legal guardian. - Subject in a social or sanitary establishment. - Subject in an emergency situation. - Volunteer having been paid more than 4500€ to take part in biomedical researches over the previous 12 months.· - Pregnant or nursing woman or planning to be pregnant during the study. - Subject likely to be non observant to the study according to the investigator interpretation. - Patient registered as being in exclusion period in the French Health Minister File of Patients. - Subject suffering from a serious or progressive disease(s) that the investigator judges may interfere with the study. - Subject with a congenital or established immunity defect. - Subject with potentially malign or pre cancerous lesions. - Subject having a cutaneous pathology on the test zones except psoriasis. - Subject with clinical signs of infection on the test zones. - Subject with know allergy or hypersensitivity to a constituent of the products (in particular to salicylic compounds or any of substances used as a vehicle), as well as allergy or hypersensitivity reactions to calcipotriol ointment 0.005%. - Subject with any other skin disease that makes implementation of the protocol or interpretation of the study results difficult at investigator criteria. - Subject with know hypercalcemia. - History of erythrodermic, pustular psoriasis or severe psoriasis requiring hospitalisation. - Unstable psoriasis or psoriasis other than plaque-type. - Use of any topical anti-psoriatic therapy in selected plaques within two weeks of the study entry and during the study. - Use of any systemic anti-psoriatic therapy (including phototherapy) within 8 weeks prior to the study entry and during the study. - Subject receiving topical or systemic medical treatment: * Acetylsalicylic acid, anti-inflammatory, antihistamines drugs, or antibiotics in the week preceding the D0 and during the study, *immuno-suppressors and/or corticoids in the month preceding the D0 and during the study (stabilized treatment with inhaled corticosteroids for asthma and/ or nasal topical steroids for rhinitis will be allowed), *Topical tar derivatives, psoralenes, phototherapy or vitamin D derivatives in the 3 weeks prior to randomization. *Systemic retinoids (ex: Roaccutane®) in the six months preceding the D0 and during the study, *Any other treatment stabilized likely to interfere the results since less than one month before the D0. - Subject who was exposed to an UV sun lamp or excessive exposure to the sun within the month prior to the study and during the study. - Subject using dermopharmaceutical or cosmetics products (including keratolytics, salicylic acid, lactic acid, urea) other than emollients on the tested area over the period of the study. - Subject who has a recent history (within previous 12 months) of drug addiction or alcohol abuse. - Active tobacco smoker (more than 10 cigarettes/day). Exclusions : - Patient who presents a Serious Adverse effect, imputable or not to one of the treatments. - Patient who does not collaborate in his/her treatment, under the conditions provided by the information consent. - Patient whose clinical condition requires the application of products on the studied lesions other than the tested and compensation treatments allowed by the protocol.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To compare the clinical efficacy of UR-1505 (0.5%, 2% and 4%) applied once daily during 4 weeks with a vehicle without active ingredients and with an active treatment in adult patients with mild to moderate plaque-type psoriasis.;Secondary Objective: - To assess the dose response relationship of three growing concentrations of UR-1505 ointment. - To assess safety and local tolerability of the experimental treatments. - To explore the global evaluation of each formulation.;Primary end point(s): The primary end-point will be the differences in the change from baseline between UR-1505 at three concentrations (0.5%, 2% and 4%) and the active and negative controls in the localized PASI score (sum of values for scores in scaling, erythema and elevation) over four-week treatment period, as assessed by clinical examination by the dermatologist. | — |
Countries
France
Outcome results
None listed