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

Glenmark Farmacêutica Ltda50 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Plaque Psoriasis

Interventions

Each patient will receive a sample of the drug test (tazarotene 0.1%) and a control sample of the drug (calcipotriene 0.005%).DRUG

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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

Data from ClinicalTrials.gov

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