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

• Status: Suspended
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Glenmark Farmacêutica Ltda
• Treatments: Calcipotriene; Nicotinic Acids; Tazarotene

Criteria

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