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

This study has been completed.
Sponsor:
Information provided by:
L.A.L Clinica Pesquisa e Desenvolvimento Ltda.
ClinicalTrials.gov Identifier:
NCT01229085
First received: February 8, 2008
Last updated: October 26, 2010
Last verified: February 2008
  Purpose

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 Intervention Phase
Psoriasis
Drug: memotasone + salicylic acid
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: CLINICAL ASSESSMENT OF THE EFFECTIVENESS OF ASSOCIATION MONETASONE FUROATE 0.1% SALICYLIC ACID AND 5% FOR SUBMISSION OF OINTMENT TOPICAL DERMATOLOGICAL USE OF LABORATORY Glenmark Pharmaceuticals Ltd, IN PATIENTS WITH PSORIASIS.

Resource links provided by NLM:


Further study details as provided by L.A.L Clinica Pesquisa e Desenvolvimento Ltda.:

Primary Outcome Measures:
  • 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. ] [ Designated as safety issue: Yes ]
    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.


Enrollment: 71
Study Start Date: September 2006
Study Completion Date: October 2007
Primary Completion Date: October 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Test
mometasone 0,1% + salicylic acid 5%
Drug: memotasone + salicylic acid
mometasone 0,1% + salicylic acid 5%.

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.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  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: NCT01229085

Locations
Brazil
LAL Clinica Pesquisa e Desenvolvimento Ltda.
Valinhos, SP, Brazil, 13270000
Sponsors and Collaborators
L.A.L Clinica Pesquisa e Desenvolvimento Ltda.
  More Information

No publications provided

Responsible Party: Alexandre Frederico, LAL Clinica
ClinicalTrials.gov Identifier: NCT01229085     History of Changes
Other Study ID Numbers: SALMOGLEN20906
Study First Received: February 8, 2008
Last Updated: October 26, 2010
Health Authority: Brazil: National Health Surveillance Agency

Keywords provided by L.A.L Clinica Pesquisa e Desenvolvimento Ltda.:
Psoriasis, mometasone, salicylic acid.

Additional relevant MeSH terms:
Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases
Salicylic Acid
Salicylates
Mometasone furoate
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Antifungal Agents
Keratolytic Agents
Dermatologic Agents
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Central Nervous System Agents
Anti-Allergic Agents

ClinicalTrials.gov processed this record on July 20, 2014