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

G

Glenmark Farmacêutica Ltda

Status

Suspended

Conditions

Plaque Psoriasis

Treatments

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

Funder types

Industry

Identifiers

NCT01279629
MED 865-10v3

Details and patient eligibility

About

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.

Enrollment

50 estimated patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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

Trial design

50 participants in 2 patient groups

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

Trial contacts and locations

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Data sourced from clinicaltrials.gov

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