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

Primary Purpose

Psoriasis

Status
Completed
Phase
Phase 3
Locations
Brazil
Study Type
Interventional
Intervention
memotasone + salicylic acid
Sponsored by
Azidus Brasil
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Psoriasis focused on measuring Psoriasis, mometasone, salicylic acid.

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • LAL Clinica Pesquisa e Desenvolvimento Ltda.

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Test

Arm Description

mometasone 0,1% + salicylic acid 5%

Outcomes

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.
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.

Secondary Outcome Measures

Full Information

First Posted
February 8, 2008
Last Updated
October 26, 2010
Sponsor
Azidus Brasil
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1. Study Identification

Unique Protocol Identification Number
NCT01229085
Brief Title
Efficacy Study of the Combination Mometasone + Salicylic Acid in Patients With Psoriasis
Acronym
Psoriasis
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.
Study Type
Interventional

2. Study Status

Record Verification Date
February 2008
Overall Recruitment Status
Completed
Study Start Date
September 2006 (undefined)
Primary Completion Date
October 2007 (Actual)
Study Completion Date
October 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Azidus Brasil

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Psoriasis
Keywords
Psoriasis, mometasone, salicylic acid.

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
71 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Test
Arm Type
Experimental
Arm Description
mometasone 0,1% + salicylic acid 5%
Intervention Type
Drug
Intervention Name(s)
memotasone + salicylic acid
Intervention Description
mometasone 0,1% + salicylic acid 5%.
Primary Outcome Measure Information:
Title
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.
Description
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.
Time Frame
45 days of treatment.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Facility Information:
Facility Name
LAL Clinica Pesquisa e Desenvolvimento Ltda.
City
Valinhos
State/Province
SP
ZIP/Postal Code
13270000
Country
Brazil

12. IPD Sharing Statement

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

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