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Effectiveness of Association Mometasone Furoate 0.1% and Salicylic Acid 5% Compared With Mometasone Furoate (Psoriasis)

This study has suspended participant recruitment.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01228656
First Posted: October 26, 2010
Last Update Posted: October 26, 2010
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:
Azidus Brasil
  Purpose
The aims is to evaluate the efficacy and comparative isolation of the association Mometasone furoate + Salicylic Acid and the substance isolated Mometasone furoate produced by the Laboratory Glenmark Pharmaceuticals Ltd. in patients of both sexes, patients with plaque psoriasis grade mild to moderate.

Condition Intervention Phase
Plaque Psoriasis Drug: mometasone furoate + salicylic acid Drug: Mometasone furoate Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: CLINICAL EVALUATION OF EFFECTIVENESS OF ASSOCIATION MOMETASONE FUROATE 0.1% AND SALICYLIC ACID 5% COMPARED WITH 0.1% MOMETASONE FUROATE INSULATED TOPICAL USE OF LABORATORY Glenmark Pharmaceuticals Ltd, IN PATIENTS WITH PSORIASIS IN PLATE

Resource links provided by NLM:


Further study details as provided by Azidus Brasil:

Primary Outcome Measures:
  • Evaluating the effectiveness and comparative isolation of the association mometasone furoate + salicylic acid and the substance isolated mometasone furoate [ Time Frame: 2 months of treatment. ]

Secondary Outcome Measures:
  • Evaluation by means of analytical propedeutics medical improvement in clinical signs and symptoms related to plaque psoriasis. [ Time Frame: 2 months of treatment. ]

Enrollment: 40
Study Start Date: September 2006
Estimated Study Completion Date: October 2011
Estimated Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: -mometasone furoate associated with salicylic acid Drug: mometasone furoate + salicylic acid
Dermatologic ointment applied once a day.
Active Comparator: -mometasone furoate Drug: Mometasone furoate
Dermatologic ointment applied once a day

Detailed Description:
The specific objective is to evaluate through analytical propedeutics medical improvement in clinical signs and symptoms related to plaque psoriasis. The study will be conducted with 40 patients who will deal with two symmetrical lesions of his body being identified by the clinician that a party should be treated in a double-blind only with mometasone furoate cream containing 0.1% and another with the combination of furoate of mometasone 0.1% + Salicylic Acid 5%. The group of patients to be treated must be adults of both sexes, aged 18-70 years with good mental and physical health to sign the Informed Consent and who are clinically assessed by dermatologists in the study as having mild plaque psoriasis and moderate. The association made a proposal of effectiveness was developed and is produced by the Laboratory Glenmark Pharmaceuticals Ltd., as well as its isolated version of the pilot (mometasone furoate 0.1%). This study should be characterized as Phase II multicenter not.
  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:   Yes
Criteria

Inclusion Criteria:

  • Adults of both sexes, regardless of color or social class;
  • Age 18 or older, with good mental health;
  • Patients with plaque psoriasis of mild to moderate;
  • Patients who agree to participate and sign the Informed Consent and
  • Clarified (appendix);
  • Patients who agree to return for follow-up visits.

Exclusion Criteria:

  • Patients who are making use of biologics, steroids or steroidal anti-inflammatory and non-steroidal or who made use of these topical medications until 15 days ago 30 days ago or when occurred in oral administration;
  • Patients who are exposing themselves to the sun 15 days before the study began or during the course of the same.
  • Patients who are making use of acetaminophen;
  • Patients who do not agree to the terms described in the informed consent Informed Consent;
  • Patients who also have psoriatic plaques of skin disorders caused by fungi or bacteria and who are making use of antimycotics or antibiotics;
  • Lions and other types of skin damage than those psoriasis;
  • Pregnant and nursing women;
  • Patients using oral anticoagulants.
  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): NCT01228656


Sponsors and Collaborators
Azidus Brasil
Investigators
Principal Investigator: Alexandre Frederico, Doctor LAL Clinical Reseach e Development Ltda
  More Information

Responsible Party: Alexandre Frederico, LAL Clínica
ClinicalTrials.gov Identifier: NCT01228656     History of Changes
Other Study ID Numbers: SALMOGLEN10906
Psoriasis
First Submitted: February 7, 2008
First Posted: October 26, 2010
Last Update Posted: October 26, 2010
Last Verified: February 2008

Keywords provided by Azidus Brasil:
Psoriasis

Additional relevant MeSH terms:
Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases
Mometasone Furoate
Salicylates
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
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action