Text Size

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
History of Changes
  Purpose

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.


Condition Intervention Phase
Plaque Psoriasis
 Drug: mometasone furoate + salicylic acid
Drug: Mometasone furoate
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:

MedlinePlus related topics: Psoriasis
U.S. FDA Resources

Further study details as provided by L.A.L Clinica Pesquisa e Desenvolvimento Ltda.:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 40
Study Start Date: September 2006
Estimated Study Completion Date: October 2011
Estimated Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: -mometasone furoate associated with salicylic acid Drug: mometasone furoate + salicylic acid
Dermatologic ointment applied once a day.
Active Comparator: -mometasone furoate Drug: Mometasone furoate
Dermatologic ointment applied once a day

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01228656

Sponsors and Collaborators
L.A.L Clinica Pesquisa e Desenvolvimento Ltda.
Investigators
Principal Investigator: Alexandre Frederico, Doctor LAL Clinical Reseach e Development Ltda
  More Information

No publications provided

Responsible Party: Alexandre Frederico, LAL Clínica
ClinicalTrials.gov Identifier: NCT01228656     History of Changes
Other Study ID Numbers: SALMOGLEN10906, Psoriasis
Study First Received: February 7, 2008
Last Updated: October 25, 2010
Health Authority: Brazil: National Health Surveillance Agency

Keywords provided by L.A.L Clinica Pesquisa e Desenvolvimento Ltda.:
Psoriasis

Additional relevant MeSH terms:
Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases
Salicylic Acid
Salicylates
Mometasone furoate
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Antifungal Agents
Keratolytic Agents
Dermatologic Agents
Anti-Inflammatory Agents, Non-Steroidal
 Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Central Nervous System Agents
Anti-Allergic Agents

ClinicalTrials.gov processed this record on May 21, 2013