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

NCT ID: NCT01279629

Last Updated: 2011-06-20

Basic Information

• Recruitment Status: SUSPENDED
• Total Enrollment: 50 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2011-02-28

Brief 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.

Conditions

Plaque Psoriasis

Study Groups

Tazarotene 0.1%

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

Intervention Type: 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.

Calcipotriol 0.005%

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

Intervention Type: 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.

Interventions

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.

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Glenmark Farmacêutica Ltda

INDUSTRY

Sponsor Role: lead

Responsible Party

Glenmark Farmacêutica Ltda

Principal Investigators

Sergio Schalka

Role: PRINCIPAL_INVESTIGATOR

Medcin Instituto da Pele Ltda

Other Identifiers

MED 865-10v3

Identifier Type: -

Identifier Source: org_study_id