Open Clinical Study, Comparing Non-inferiority of Chronic Plaque Psoriasis

Study Overview
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Brief Summary
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The purpose of this study is: To evaluate the efficacy of the drugs under study for treating chronic plaque psoriasis. - Population: 50 patients will be selected from both sexes, healthy, between 18 and 65 years with a clinical diagnosis of chronic plaque psoriasis with PASI <20%, according to the criteria of inclusion and exclusion.

Official Title
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Open Clinical Study, Comparing Non-inferiority for Efficacy of the Drug Tazarotene 0.1% Versus the Comparator Drug Calcipotriol 0.005% in the Treatment of Chronic Plaque Psoriasis

Conditions
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Plaque Psoriasis

Intervention / Treatment
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* Drug: Each patient will receive a sample of the drug test (tazarotene 0.1%) and a control sample of the drug (calcipotriene 0.005%).


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age range: Between 18 and 65 A patient with chronic plaque psoriasis PASI <20% Presence of bilateral lesions with at least 2 cm in diameter and each with some degree of symmetry Levels of serum calcium and phosphorus within the normal range of reference or in case of changes, classified as irrelevant by the investigator In the case of female patients, agreement or maintenance of safe use of contraception such as barrier (condom, diaphragm), hormonal contraceptives (pills, implants or injections), IUDs, or abstinence (no sex) Reading, understanding, agreement and signature of the patient in the Term of Consent. Exclusion Criteria: Gestation (confirmed by urine test indicator) Lactation History of hypersensitivity to components of medicines Psoriasis with different clinical presentation of the plates Clinical picture of psoriasis involving only the scalp, face, groin, armpit and / or other intertriginous area Patient requires the use of concomitant medication (topical or systemic) that may alter the course of the disease during the study period Use of any systemic treatment for psoriasis within 12 weeks before the start of the study Use of systemic corticosteroids within 28 days before the start of the study Use of topical corticosteroids or other topical therapies in the areas of assessment within 02 weeks before the start of the study Use of phototherapy (UVB / UVA-P) within 04 weeks before the start of the study Patients who have participated in another clinical study within 30 days before the start of the study Use of any medication or possession of any disease which, in the opinion of the investigator might interfere with the performance or interpretation of the study Laboratory tests changed (serum AST and ALT, alkaline phosphatase, urea and creatinine, total bilirubin and fractions) Patients with demonstrated hypercalcemia or evidence of toxicity of vitamin D Other conditions deemed reasonable by the medical investigator as to the disqualification of the individual from study participation

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Tazarotene 0.1%<br> | Drug: Each patient will receive a sample of the drug test (tazarotene 0.1%) and a control sample of the drug (calcipotriene 0.005%).<br>* Apply the medication once daily, preferably at night, in quantities sufficient to cover only the lesions with a thin layer of the product (an average of 2 mg/cm2).Apply only in lesions of the right hemisphere.<br>|
| Calcipotriol 0.005%<br> | Drug: Each patient will receive a sample of the drug test (tazarotene 0.1%) and a control sample of the drug (calcipotriene 0.005%).<br>* Apply the medication once daily, preferably at night, in quantities sufficient to cover only the lesions with a thin layer of the product (an average of 2 mg/cm2).Apply only in lesions of the right hemisphere.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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chronic plaque psoriasis, To evaluate the efficacy of the drugs under study for treating chronic plaque psoriasis