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

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.

Study Overview

• Status: Suspended
• Conditions: Plaque Psoriasis
• Intervention / Treatment: Drug: mometasone furoate + salicylic acid; Drug: Mometasone furoate

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.

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Phase 2

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 61 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Evaluating the effectiveness and comparative isolation of the association mometasone furoate + salicylic acid and the substance isolated mometasone furoate	2 months of treatment.

Secondary Outcome Measures

Outcome Measure	Time Frame
Evaluation by means of analytical propedeutics medical improvement in clinical signs and symptoms related to plaque psoriasis.	2 months of treatment.

Collaborators and Investigators

• Sponsor: Azidus Brasil
• Investigators: Principal Investigator: Alexandre Frederico, Doctor, LAL Clinical Reseach e Development Ltda

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2006
• Primary Completion (Actual): October 1, 2010
• Study Completion: October 1, 2011

Study Registration Dates

• First Submitted: February 7, 2008
• First Submitted That Met QC Criteria: October 25, 2010
• First Posted (Estimate): October 26, 2010

Study Record Updates

• Last Update Posted (Actual): November 3, 2022
• Last Update Submitted That Met QC Criteria: November 1, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Keywords: Psoriasis
• Additional Relevant MeSH Terms: Skin Diseases; Skin Diseases, Papulosquamous; Psoriasis; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Cyclooxygenase Inhibitors; Dermatologic Agents; Antifungal Agents; Keratolytic Agents; Anti-Allergic Agents; Salicylic Acid; Mometasone Furoate; Salicylates
• Other Study ID Numbers: SALMOGLEN10906; Psoriasis