Clinical trial NCT01279629: Open Clinical Study, Comparing Non-inferiority of Chronic Plaque Psoriasis
Official title: 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
Study type: OBSERVATIONAL
Overall status: SUSPENDED
Conditions: Plaque Psoriasis
Keywords: chronic plaque psoriasis
To evaluate the efficacy of the drugs under study for treating chronic plaque psoriasis
Lead sponsor: Glenmark Farmacêutica Ltda
Sponsor class: INDUSTRY
First posted: 2011-01-19
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
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.

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.


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

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Medcin Instituto da Pele Ltda
name: Sergio Schalka
role: PRINCIPAL_INVESTIGATOR
References: