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

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

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 Overview

• Status: Suspended
• Conditions: Plaque Psoriasis
• Intervention / Treatment: Drug: Each patient will receive a sample of the drug test (tazarotene 0.1%) and a control sample of the drug (calcipotriene 0.005%).

• Study Type: Observational
• Enrollment (Anticipated): 50

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study 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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

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

Collaborators and Investigators

• Sponsor: Glenmark Farmacêutica Ltda
• Investigators: Principal Investigator: Sergio Schalka, Medcin Instituto da Pele Ltda

Study record dates

Study Major Dates

• Study Start: February 1, 2011

Study Registration Dates

• First Submitted: January 18, 2011
• First Submitted That Met QC Criteria: January 18, 2011
• First Posted (ESTIMATE): January 19, 2011

Study Record Updates

• Last Update Posted (ESTIMATE): June 20, 2011
• Last Update Submitted That Met QC Criteria: June 17, 2011
• Last Verified: January 1, 2011

More Information

Terms related to this study

• Keywords: chronic plaque psoriasis; To evaluate the efficacy of the drugs under study for treating chronic plaque psoriasis
• Additional Relevant MeSH Terms: Skin Diseases; Skin Diseases, Papulosquamous; Psoriasis; Dermatologic Agents; Keratolytic Agents; Calcipotriene; Tazarotene
• Other Study ID Numbers: MED 865-10v3