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CompletedNCT01229085PsoriasisUpdated Oct 27, 2010

Efficacy Study of the Combination Mometasone + Salicylic Acid in Patients With Psoriasis

A Phase 3 interventional study of memotasone + salicylic acid in Psoriasis, sponsored by Azidus Brasil. Completed at 1 site in Brazil. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2010-10-27.

Sponsored by Azidus Brasil · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
71
Allocation
Non-randomized
Ages
18 Years to 70 Years
Sex
All
01

Study summary

To evaluate the efficacy of the combination of mometasone furoate 0.1% and Salicylic Acid 5% in patients of both sexes who presented clinical symptoms of psoriasis of mild to moderate.

Read the detailed description

Phase III clinical trial, systematic sampling, open-label study that evaluated the efficacy of the combination of mometasone furoate 0.1% and 5% salicylic acid in 71 patients with lesions of mild to moderate psoriasis treated for up to 45 days or less than this, at the discretion of the investigator. The results were statistically analyzed and investigational data and their conclusions are referred to in this report.

02

Conditions studied

  • Psoriasis

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Keywords

  • Psoriasis, mometasone, salicylic acid.
03

In context

Psoriasis

1,928 studies on the registry are indexed under Psoriasis; 234 are open to participants now.

This study's enrollment of 71 is close to the median of 70 across 1,472 interventional studies indexed under Psoriasis.

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Lead sponsor

Azidus Brasil is the lead sponsor of 80 studies on the registry; 5 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Adults of both sexes, regardless of color or social class;
  • Age 18 or older, with good mental health;
  • Psoriasis patients with mild to moderate;
  • Patients who agreed to participate and signed the
  • Clarified (appendix);
  • Patients who agreed to return for follow-up visits.

Exclusion criteria

Exclusion Criteria:

  • Patients who were making use of biologics, corticosteroids or nonsteroidal anti-inflammatory and non-steroid, or who made use of these topical medications until 15 days before inclusion or 30 days before inclusion when the administration was orally;
  • Patients who were exposed to the sun 15 days before the study began or during the course of the same;
  • Patients who were making use of acetaminophen;
  • Patients who did not agree to the terms described in the IC informed consent, - Patients who also had psoriatic plaques of skin disorders caused by fungi or bacteria and they were making use of antibiotic or antifungal;
  • Lions and other types of skin damage that was not psoriasis;
  • Pregnant and nursing women;
  • Patients using oral anticoagulants.
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
71 participants (actual)

Study arms

  • Experimental
    Test

    mometasone 0,1% + salicylic acid 5%

    Drug: memotasone + salicylic acid

Interventions

  • Drugmemotasone + salicylic acid

    mometasone 0,1% + salicylic acid 5%.

06

What researchers measure

Primary outcomes

  1. To assess the safety in use as primary end point and end point as effectively isolated secondary association in patients with plaque psoriasis of mild to moderate.

    Patients will visit the center at weeks 0, 1, 2, 4 and 6 totaling 45 days. Parameters will be evaluated for erythema, plaque size, scaling, itching, thickness of the lesion as well as recording and analysis of adverse effects from treatments.

    Time frame: 45 days of treatment.

07

Study locations

1 site
  • LAL Clinica Pesquisa e Desenvolvimento Ltda.
    Valinhos, São Paulo 13270000, Brazil
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 27, 2010, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01229085
Lead sponsor
Azidus Brasil
First posted
Oct 27, 2010
Start date
Sep 2006
Primary completion
Oct 2007
Completion
Oct 2007
Last update
Oct 27, 2010

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2008. You cannot join it, but the record below documents what was studied.

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