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

Sponsor

Azidus Brasil (Industry)

Overall Status

Completed

CT.gov ID

NCT01229085

Collaborator

(none)

Enrollment

Location

Arm

Duration (Months)

5.5

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Psoriasis	Drug: memotasone + salicylic acid	Phase 3

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

71 participants

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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 Start Date :

Sep 1, 2006

Actual Primary Completion Date :

Oct 1, 2007

Actual Study Completion Date :

Oct 1, 2007

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Test mometasone 0,1% + salicylic acid 5%	Drug: memotasone + salicylic acid mometasone 0,1% + salicylic acid 5%.

Arm

Intervention/Treatment

Experimental: Test

mometasone 0,1% + salicylic acid 5%

Drug: memotasone + salicylic acid

mometasone 0,1% + salicylic acid 5%.

Outcome Measures

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. [45 days of treatment.]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	LAL Clinica Pesquisa e Desenvolvimento Ltda.	Valinhos	SP	Brazil	13270000

Sponsors and Collaborators

Azidus Brasil

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

, ,

ClinicalTrials.gov Identifier:

NCT01229085

Other Study ID Numbers:

SALMOGLEN20906

First Posted:

Oct 27, 2010

Last Update Posted:

Oct 27, 2010

Last Verified:

Feb 1, 2008

Keywords provided by , ,

Psoriasis, mometasone, salicylic acid.

Additional relevant MeSH terms:

Psoriasis

Salicylic Acid

Salicylates

Study Results

No Results Posted as of Oct 27, 2010