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

This study has suspended participant recruitment.
Sponsor:
Information provided by:
Glenmark Farmacêutica Ltda
ClinicalTrials.gov Identifier:
NCT01279629
First received: January 18, 2011
Last updated: June 17, 2011
Last verified: January 2011
History of Changes
  Purpose

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.


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

Study Type: Observational
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

Resource links provided by NLM:

MedlinePlus related topics: Psoriasis
U.S. FDA Resources

Further study details as provided by Glenmark Farmacêutica Ltda:

Estimated Enrollment: 50
Study Start Date: February 2011
Groups/Cohorts Assigned Interventions
Tazarotene 0.1% 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.
Calcipotriol 0.005% 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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
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.

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01279629

Sponsors and Collaborators
Glenmark Farmacêutica Ltda
Investigators
Principal Investigator: Sergio Schalka Medcin Instituto da Pele Ltda
  More Information

No publications provided

Responsible Party: Glenmark Farmacêutica Ltda
ClinicalTrials.gov Identifier: NCT01279629     History of Changes
Other Study ID Numbers: MED 865-10v3
Study First Received: January 18, 2011
Last Updated: June 17, 2011
Health Authority: Brazil: ANVISA

Keywords provided by Glenmark Farmacêutica Ltda:
chronic plaque psoriasis
To evaluate the efficacy of the drugs under study for treating chronic plaque psoriasis

Additional relevant MeSH terms:
Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases
Calcipotriene
Tazarotene
 Dermatologic Agents
Therapeutic Uses
Pharmacologic Actions
Keratolytic Agents

ClinicalTrials.gov processed this record on May 16, 2013