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Effectiveness of Association Mometasone Furoate 0.1% and Salicylic Acid 5% Compared With Mometasone Furoate (Psoriasis)

This study has suspended participant recruitment.
Sponsor:
Information provided by:
L.A.L Clinica Pesquisa e Desenvolvimento Ltda.
ClinicalTrials.gov Identifier:
NCT01228656
First received: February 7, 2008
Last updated: October 25, 2010
Last verified: February 2008

February 7, 2008
October 25, 2010
September 2006
October 2010   (final data collection date for primary outcome measure)
Evaluating the effectiveness and comparative isolation of the association mometasone furoate + salicylic acid and the substance isolated mometasone furoate [ Time Frame: 2 months of treatment. ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01228656 on ClinicalTrials.gov Archive Site
Evaluation by means of analytical propedeutics medical improvement in clinical signs and symptoms related to plaque psoriasis. [ Time Frame: 2 months of treatment. ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Effectiveness of Association Mometasone Furoate 0.1% and Salicylic Acid 5% Compared With Mometasone Furoate
CLINICAL EVALUATION OF EFFECTIVENESS OF ASSOCIATION MOMETASONE FUROATE 0.1% AND SALICYLIC ACID 5% COMPARED WITH 0.1% MOMETASONE FUROATE INSULATED TOPICAL USE OF LABORATORY Glenmark Pharmaceuticals Ltd, IN PATIENTS WITH PSORIASIS IN PLATE

The aims is to evaluate the efficacy and comparative isolation of the association Mometasone furoate + Salicylic Acid and the substance isolated Mometasone furoate produced by the Laboratory Glenmark Pharmaceuticals Ltd. in patients of both sexes, patients with plaque psoriasis grade mild to moderate.

The specific objective is to evaluate through analytical propedeutics medical improvement in clinical signs and symptoms related to plaque psoriasis. The study will be conducted with 40 patients who will deal with two symmetrical lesions of his body being identified by the clinician that a party should be treated in a double-blind only with mometasone furoate cream containing 0.1% and another with the combination of furoate of mometasone 0.1% + Salicylic Acid 5%. The group of patients to be treated must be adults of both sexes, aged 18-70 years with good mental and physical health to sign the Informed Consent and who are clinically assessed by dermatologists in the study as having mild plaque psoriasis and moderate. The association made a proposal of effectiveness was developed and is produced by the Laboratory Glenmark Pharmaceuticals Ltd., as well as its isolated version of the pilot (mometasone furoate 0.1%). This study should be characterized as Phase II multicenter not.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Plaque Psoriasis
  • Drug: mometasone furoate + salicylic acid
    Dermatologic ointment applied once a day.
  • Drug: Mometasone furoate
    Dermatologic ointment applied once a day
  • Experimental: -mometasone furoate associated with salicylic acid
    Intervention: Drug: mometasone furoate + salicylic acid
  • Active Comparator: -mometasone furoate
    Intervention: Drug: Mometasone furoate
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Suspended
40
October 2011
October 2010   (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;
  • Patients with plaque psoriasis of mild to moderate;
  • Patients who agree to participate and sign the Informed Consent and
  • Clarified (appendix);
  • Patients who agree to return for follow-up visits.

Exclusion Criteria:

  • Patients who are making use of biologics, steroids or steroidal anti-inflammatory and non-steroidal or who made use of these topical medications until 15 days ago 30 days ago or when occurred in oral administration;
  • Patients who are exposing themselves to the sun 15 days before the study began or during the course of the same.
  • Patients who are making use of acetaminophen;
  • Patients who do not agree to the terms described in the informed consent Informed Consent;
  • Patients who also have psoriatic plaques of skin disorders caused by fungi or bacteria and who are making use of antimycotics or antibiotics;
  • Lions and other types of skin damage than those psoriasis;
  • Pregnant and nursing women;
  • Patients using oral anticoagulants.
Both
18 Years to 65 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT01228656
SALMOGLEN10906, Psoriasis
No
Alexandre Frederico, LAL Clínica
L.A.L Clinica Pesquisa e Desenvolvimento Ltda.
Not Provided
Principal Investigator: Alexandre Frederico, Doctor LAL Clinical Reseach e Development Ltda
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