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

NCT ID: NCT01229085

Last Updated: 2010-10-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

71 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-09-30

Study Completion Date

2007-10-31

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.

Conditions

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Psoriasis

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Test

mometasone 0,1% + salicylic acid 5%

Group Type EXPERIMENTAL

memotasone + salicylic acid

Intervention Type DRUG

mometasone 0,1% + salicylic acid 5%.

Interventions

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memotasone + salicylic acid

mometasone 0,1% + salicylic acid 5%.

Intervention Type DRUG

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Azidus Brasil

INDUSTRY

Sponsor Role lead

Responsible Party

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LAL Clinica

Locations

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LAL Clinica Pesquisa e Desenvolvimento Ltda.

Valinhos, São Paulo, Brazil

Site Status

Countries

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Brazil

Other Identifiers

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SALMOGLEN20906

Identifier Type: -

Identifier Source: org_study_id