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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 September 22, 2014