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

Information source: Glenmark Farmacêutica Ltda
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Plaque Psoriasis

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

Phase: N/A

Status: Suspended

Sponsored by: Glenmark Farmacêutica Ltda

Official(s) and/or principal investigator(s):
Sergio Schalka, Principal Investigator, Affiliation: Medcin Instituto da Pele Ltda

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.

Clinical Details

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 design: N/A

Eligibility

Minimum age: 18 Years. Maximum age: 65 Years. Gender(s): Both.

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

Locations and Contacts

Additional Information

Starting date: February 2011
Last updated: June 17, 2011

Page last updated: August 23, 2015

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