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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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.

Conditions
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Psoriasis

Intervention / Treatment
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* Drug: memotasone + salicylic acid


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Test<br>mometasone 0,1% + salicylic acid 5% | Drug: memotasone + salicylic acid<br>* mometasone 0,1% + salicylic acid 5%.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 45 days of treatment. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Psoriasis, mometasone, salicylic acid.