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

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

NCT01279629•Glenmark Farmacêutica Ltda

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - 65 years

Sex

ALL

Healthy Volunteers

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
+5 more criteria

Key Dates

Start Date

February 1, 2011

Last Updated

June 20, 2011

Enrollment

ESTIMATED participants

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

Long-Term Safety Study of Deucravacitinib Versus Ustekinumab in Participants With Psoriasis (PRAGMATYK)

NCT07116967

Plaque Psoriasis

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RECRUITINGPHASE3

A Long-Term Study of Zasocitinib in Children and Teenagers With Plaque Psoriasis

NCT07250802

Plaque Psoriasis

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RECRUITINGPHASE2

An Open-Label Extension Study of ORKA-001 in Participants With Plaque Psoriasis

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: June 20, 2011Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

Long-Term Safety Study of Deucravacitinib Versus Ustekinumab in Participants With Psoriasis (PRAGMATYK)

A Long-Term Study of Zasocitinib in Children and Teenagers With Plaque Psoriasis

An Open-Label Extension Study of ORKA-001 in Participants With Plaque Psoriasis

Dose Ranging Study of ORKA-001 in Patients With Moderate-to-Severe Plaque Psoriasis

A Study to Assess the Concentration of Bimekizumab in Mature Breast Milk From Mothers Receiving Treatment With Bimzelx® (Bimekizumab)

A Study to Evaluate Effectiveness and Safety of a TYK2 Inhibitor in Subjects With Moderate to Severe Plaque Psoriasis