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

This study has suspended participant recruitment.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01279629
First Posted: January 19, 2011
Last Update Posted: June 20, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Glenmark Farmacêutica Ltda
  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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01279629


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

Responsible Party: Glenmark Farmacêutica Ltda
ClinicalTrials.gov Identifier: NCT01279629     History of Changes
Other Study ID Numbers: MED 865-10v3
First Submitted: January 18, 2011
First Posted: January 19, 2011
Last Update Posted: June 20, 2011
Last Verified: January 2011

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
Nicotinic Acids
Dermatologic Agents
Keratolytic Agents
Vitamin B Complex
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs