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Clinical Trial Details — Status: Suspended

Administrative data

NCT number NCT01279629
Other study ID # MED 865-10v3
Secondary ID
Status Suspended
Phase N/A
First received January 18, 2011
Last updated June 17, 2011
Start date February 2011

Study information

Verified date January 2011
Source Glenmark Farmacêutica Ltda
Contact n/a
Is FDA regulated No
Health authority Brazil: ANVISA
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Suspended
Enrollment 50
Est. completion date
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 65 Years
Eligibility 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 Design

N/A


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Glenmark Farmacêutica Ltda
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