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

Primary Purpose

Plaque Psoriasis

Status

Suspended

Phase

Phase 2

Locations

Study Type

Interventional

Intervention

mometasone furoate + salicylic acid

Mometasone furoate

About this trial

This is an interventional treatment trial for Plaque Psoriasis focused on measuring Psoriasis

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

-mometasone furoate associated with salicylic acid

-mometasone furoate

Arm Description

Outcomes

Primary Outcome Measures

Evaluating the effectiveness and comparative isolation of the association mometasone furoate + salicylic acid and the substance isolated mometasone furoate

Secondary Outcome Measures

Evaluation by means of analytical propedeutics medical improvement in clinical signs and symptoms related to plaque psoriasis.

Full Information

NCT ID

NCT01228656

First Posted

February 7, 2008

Last Updated

November 1, 2022

Sponsor

Azidus Brasil

1. Study Identification

Unique Protocol Identification Number

NCT01228656

Brief Title

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

Acronym

Psoriasis

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

Study Type

Interventional

2. Study Status

Record Verification Date

November 2022

Overall Recruitment Status

Suspended

Study Start Date

September 2006 (Actual)

Primary Completion Date

October 2010 (Actual)

Study Completion Date

October 2011 (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Azidus Brasil

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Plaque Psoriasis

Keywords

Psoriasis

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

40 (Actual)

8. Arms, Groups, and Interventions

Arm Title

-mometasone furoate associated with salicylic acid

Arm Type

Experimental

Arm Title

-mometasone furoate

Arm Type

Active Comparator

Intervention Type

Drug

Intervention Name(s)

mometasone furoate + salicylic acid

Intervention Description

Dermatologic ointment applied once a day.

Intervention Type

Drug

Intervention Name(s)

Mometasone furoate

Intervention Description

Dermatologic ointment applied once a day

Primary Outcome Measure Information:

Title

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.

Secondary Outcome Measure Information:

Title

Evaluation by means of analytical propedeutics medical improvement in clinical signs and symptoms related to plaque psoriasis.

Time Frame

2 months of treatment.

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Alexandre Frederico, Doctor

Organizational Affiliation

LAL Clinical Reseach e Development Ltda

Official's Role

Principal Investigator

12. IPD Sharing Statement

Learn more about this trial

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

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