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

February 8, 2008
October 26, 2010
September 2006
October 2007   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01229085 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Efficacy Study of the Combination Mometasone + Salicylic Acid in Patients With Psoriasis
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.

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.

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.

Interventional
Phase 3
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Psoriasis
Drug: memotasone + salicylic acid
mometasone 0,1% + salicylic acid 5%.
Experimental: Test
mometasone 0,1% + salicylic acid 5%
Intervention: Drug: memotasone + salicylic acid
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
71
October 2007
October 2007   (final data collection date for primary outcome measure)

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.
Both
18 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
Brazil
 
NCT01229085
SALMOGLEN20906
No
Alexandre Frederico, LAL Clinica
L.A.L Clinica Pesquisa e Desenvolvimento Ltda.
Not Provided
Not Provided
L.A.L Clinica Pesquisa e Desenvolvimento Ltda.
February 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP