Working… Menu

Efficacy Study of the Combination Mometasone + Salicylic Acid in Patients With Psoriasis (Psoriasis)

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. Identifier: NCT01229085
Recruitment Status : Completed
First Posted : October 27, 2010
Last Update Posted : October 27, 2010
Information provided by:
Azidus Brasil

Brief Summary:
To evaluate the efficacy of the combination of mometasone furoate 0.1% and Salicylic Acid 5% in patients of both sexes who presented clinical symptoms of psoriasis of mild to moderate.

Condition or disease Intervention/treatment Phase
Psoriasis Drug: memotasone + salicylic acid Phase 3

Detailed Description:
Phase III clinical trial, systematic sampling, open-label study that evaluated the efficacy of the combination of mometasone furoate 0.1% and 5% salicylic acid in 71 patients with lesions of mild to moderate psoriasis treated for up to 45 days or less than this, at the discretion of the investigator. The results were statistically analyzed and investigational data and their conclusions are referred to in this report.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 71 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : September 2006
Actual Primary Completion Date : October 2007
Actual Study Completion Date : October 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Psoriasis

Arm Intervention/treatment
Experimental: Test
mometasone 0,1% + salicylic acid 5%
Drug: memotasone + salicylic acid
mometasone 0,1% + salicylic acid 5%.

Primary Outcome Measures :
  1. To assess the safety in use as primary end point and end point as effectively isolated secondary association in patients with plaque psoriasis of mild to moderate. [ Time Frame: 45 days of treatment. ]
    Patients will visit the center at weeks 0, 1, 2, 4 and 6 totaling 45 days. Parameters will be evaluated for erythema, plaque size, scaling, itching, thickness of the lesion as well as recording and analysis of adverse effects from treatments.

Information from the National Library of Medicine

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, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Adults of both sexes, regardless of color or social class;
  • Age 18 or older, with good mental health;
  • Psoriasis patients with mild to moderate;
  • Patients who agreed to participate and signed the
  • Clarified (appendix);
  • Patients who agreed to return for follow-up visits.

Exclusion Criteria:

  • Patients who were making use of biologics, corticosteroids or nonsteroidal anti-inflammatory and non-steroid, or who made use of these topical medications until 15 days before inclusion or 30 days before inclusion when the administration was orally;
  • Patients who were exposed to the sun 15 days before the study began or during the course of the same;
  • Patients who were making use of acetaminophen;
  • Patients who did not agree to the terms described in the IC informed consent, - Patients who also had psoriatic plaques of skin disorders caused by fungi or bacteria and they were making use of antibiotic or antifungal;
  • Lions and other types of skin damage that was not psoriasis;
  • Pregnant and nursing women;
  • Patients using oral anticoagulants.

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 identifier (NCT number): NCT01229085

Layout table for location information
LAL Clinica Pesquisa e Desenvolvimento Ltda.
Valinhos, SP, Brazil, 13270000
Sponsors and Collaborators
Azidus Brasil

Layout table for additonal information
Responsible Party: Alexandre Frederico, LAL Clinica Identifier: NCT01229085     History of Changes
Other Study ID Numbers: SALMOGLEN20906
First Posted: October 27, 2010    Key Record Dates
Last Update Posted: October 27, 2010
Last Verified: February 2008
Keywords provided by Azidus Brasil:
Psoriasis, mometasone, salicylic acid.
Additional relevant MeSH terms:
Layout table for MeSH terms
Skin Diseases, Papulosquamous
Skin Diseases
Mometasone Furoate
Salicylic Acid
Anti-Inflammatory Agents
Dermatologic Agents
Anti-Allergic Agents
Anti-Infective Agents
Antifungal Agents
Keratolytic Agents
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action