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

NCT01228656 | Suspended Phase 2

• 2 other identifiers: SALMOGLEN10906Psoriasis
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Plaque Psoriasis

Keywords

Psoriasis

Outcome Measures

Primary Outcomes (1)

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

  2 months of treatment.

Secondary Outcomes (1)

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

  2 months of treatment.

Study Arms (2)

-mometasone furoate associated with salicylic acid

EXPERIMENTAL

Drug: mometasone furoate + salicylic acid

-mometasone furoate

ACTIVE COMPARATOR

Drug: Mometasone furoate

Interventions

mometasone furoate + salicylic acid DRUG

Dermatologic ointment applied once a day.

-mometasone furoate associated with salicylic acid

Mometasone furoate DRUG

Dermatologic ointment applied once a day

-mometasone furoate

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Azidus Brasil: lead

MeSH Terms

Conditions

Psoriasis

Interventions

Mometasone Furoate; Salicylic Acid

Condition Hierarchy (Ancestors)

Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Pregnadienediols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Salicylates; Hydroxybenzoates; Benzoates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Hydroxy Acids; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Phenols

Study Officials

• Alexandre Frederico, Doctor

  LAL Clinical Reseach e Development Ltda

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator Dr. Alexandre Frederico

Study Record Dates

• First Submitted: February 7, 2008
• First Posted: October 26, 2010
• Study Start: September 1, 2006
• Primary Completion: October 1, 2010
• Study Completion: October 1, 2011
• Last Updated: November 3, 2022

Record last verified: 2022-11