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

Overview

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.

Full Title of Study: “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”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Double (Participant, Investigator)
  • Study Primary Completion Date: October 2010

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.

Interventions

  • Drug: mometasone furoate + salicylic acid
    • Dermatologic ointment applied once a day.
  • Drug: Mometasone furoate
    • Dermatologic ointment applied once a day

Arms, Groups and Cohorts

  • Experimental: -mometasone furoate associated with salicylic acid
  • Active Comparator: -mometasone furoate

Clinical Trial Outcome Measures

Primary 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 Measures

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

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 65 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Azidus Brasil
  • Provider of Information About this Clinical Study
    • Principal Investigator: Azidus Brasil, Principal Investigator Dr. Alexandre Frederico – Azidus Brasil
  • Overall Official(s)
    • Alexandre Frederico, Doctor, Principal Investigator, LAL Clinical Reseach e Development Ltda

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.