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

This study has been completed.

Sponsor:

Information provided by:

L.A.L Clinica Pesquisa e Desenvolvimento Ltda.

ClinicalTrials.gov Identifier:

NCT01229085

First received: February 8, 2008

Last updated: October 26, 2010

Last verified: February 2008

History of Changes

Tracking Information
First Received Date ^ICMJE	February 8, 2008
Last Updated Date	October 26, 2010
Start Date ^ICMJE	September 2006
Primary Completion Date	October 2007 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: October 26, 2010)	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. [ Time Frame: 45 days of treatment. ] [ Designated as safety issue: Yes ] 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.
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01229085 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE	Not Provided
Original Secondary Outcome Measures ^ICMJE	Not Provided
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Efficacy Study of the Combination Mometasone + Salicylic Acid in Patients With Psoriasis
Official Title ^ICMJE	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.
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.
Study Type ^ICMJE	Interventional
Study Phase	Phase 3
Study Design ^ICMJE	Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Condition ^ICMJE	Psoriasis
Intervention ^ICMJE	Drug: memotasone + salicylic acid mometasone 0,1% + salicylic acid 5%.
Study Arm (s)	Experimental: Test mometasone 0,1% + salicylic acid 5% Intervention: Drug: memotasone + salicylic acid
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	71
Completion Date	October 2007
Primary Completion Date	October 2007 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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.
Gender	Both
Ages	18 Years to 70 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Brazil

Administrative Information
NCT Number ^ICMJE	NCT01229085
Other Study ID Numbers ^ICMJE	SALMOGLEN20906
Has Data Monitoring Committee	No
Responsible Party	Alexandre Frederico, LAL Clinica
Study Sponsor ^ICMJE	L.A.L Clinica Pesquisa e Desenvolvimento Ltda.
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	L.A.L Clinica Pesquisa e Desenvolvimento Ltda.
Verification Date	February 2008
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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