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

NCT ID: NCT01228656

Last Updated: 2022-11-03

Basic Information

• Recruitment Status: SUSPENDED
• Clinical Phase: PHASE2
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-09-30
• Study Completion Date: 2011-10-31

Brief Summary

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.

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.

Conditions

Plaque Psoriasis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

-mometasone furoate associated with salicylic acid

Group Type: EXPERIMENTAL

mometasone furoate + salicylic acid

Intervention Type: DRUG

Dermatologic ointment applied once a day.

-mometasone furoate

Group Type: ACTIVE_COMPARATOR

Mometasone furoate

Intervention Type: DRUG

Dermatologic ointment applied once a day

Interventions

mometasone furoate + salicylic acid

Dermatologic ointment applied once a day.

Intervention Type: DRUG

Mometasone furoate

Dermatologic ointment applied once a day

Intervention Type: DRUG

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Azidus Brasil

INDUSTRY

Sponsor Role: lead

Responsible Party

Azidus Brasil

Principal Investigator Dr. Alexandre Frederico

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Alexandre Frederico, Doctor

Role: PRINCIPAL_INVESTIGATOR

LAL Clinical Reseach e Development Ltda

Other Identifiers

Psoriasis

Identifier Type: -

Identifier Source: secondary_id

SALMOGLEN10906

Identifier Type: -

Identifier Source: org_study_id