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

Primary Purpose

Plaque Psoriasis

Status

Suspended

Phase

Locations

Study Type

Observational

Intervention

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

About this trial

This is an observational trial for Plaque Psoriasis focused on measuring chronic plaque psoriasis, To evaluate the efficacy of the drugs under study for treating chronic plaque psoriasis

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept 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
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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Arm Label

Tazarotene 0.1%

Calcipotriol 0.005%

Arm Description

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

NCT ID

NCT01279629

First Posted

January 18, 2011

Last Updated

June 17, 2011

Sponsor

Glenmark Farmacêutica Ltda

1. Study Identification

Unique Protocol Identification Number

NCT01279629

Brief Title

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

Acronym

MED

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

2. Study Status

Record Verification Date

January 2011

Overall Recruitment Status

Suspended

Study Start Date

February 2011 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor

Glenmark Farmacêutica Ltda

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Plaque Psoriasis

Keywords

chronic plaque psoriasis, To evaluate the efficacy of the drugs under study for treating chronic plaque psoriasis

7. Study Design

Enrollment

50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Tazarotene 0.1%

Arm Title

Calcipotriol 0.005%

Intervention Type

Drug

Intervention Name(s)

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

Intervention Description

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.

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

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

Study Population Description

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.

Sampling Method

Probability Sample

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Sergio Schalka

Organizational Affiliation

Medcin Instituto da Pele Ltda

Official's Role

Principal Investigator

12. IPD Sharing Statement

Learn more about this trial

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

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