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

Psoriasis Clinical Trial

— 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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01229085
• Other study ID #: SALMOGLEN20906
• Status: Completed
• Phase: Phase 3
• First received: February 8, 2008
• Last updated: October 26, 2010
• Start date: September 2006
• Est. completion date: October 2007

Study information

• Verified date: February 2008
• Source: L.A.L Clinica Pesquisa e Desenvolvimento Ltda.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Health Surveillance Agency
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 71
• Est. completion date: October 2007
• Est. primary completion date: October 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Psoriasis

Intervention

Drug:
• memotasone + salicylic acid
mometasone 0,1% + salicylic acid 5%.

Locations

Country	Name	City	State
Brazil	LAL Clinica Pesquisa e Desenvolvimento Ltda.	Valinhos	SP

Sponsors (1)

Lead Sponsor	Collaborator
L.A.L Clinica Pesquisa e Desenvolvimento Ltda.

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Yes