PsoriasisPhase 3PsoriasisNCT01229085

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

A Phase 3 study testing memotasone + salicylic acid in people with Psoriasis, run by Azidus Brasil at 1 site in Brazil.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial 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 more about this study

Who is it for?: Ages 18 to 70 years
Conditions the study is for: Psoriasis
What is being tested?: memotasone + salicylic acid
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 71 participants
Where: 1 siteBrazil
Study dates: Sep 2006to Oct 2007
Phase: Phase 3
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 70 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

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.

Trial locations and contacts

1 site in 1 country.

Brazil1 site

LAL Clinica Pesquisa e Desenvolvimento Ltda.
Valinhos, São Paulo, 13270000

Other trials in Brazil

About this study

Official title: CLINICAL ASSESSMENT OF THE EFFECTIVENESS OF ASSOCIATION MONETASONE FUROATE 0.1% SALICYLIC ACID AND 5% FOR SUBMISSION OF OINTMENT TOPICAL DERMATOLOGICAL USE OF LABORATORY Glenmark Pharmaceuticals Ltd, IN PATIENTS WITH PSORIASIS.

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.

Conditions: Psoriasis
Being tested: memotasone + salicylic acid
Keywords: Psoriasis, mometasone, salicylic acid.
Medical subject headings: Psoriasis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

memotasone + salicylic acidDrug
mometasone 0,1% + salicylic acid 5%.

Study groups in NCT01229085
Study group	Role	What they receive
Test	Experimental	mometasone 0,1% + salicylic acid 5% Receives: Drug: memotasone + salicylic acid

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 45 days of treatment.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Sep 2006Oct 2007

First posted27 Oct 2010 (estimated)
Study startSep 2006
Primary completionOct 2007
Study completionOct 2007

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for PsoriasisStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Enrolment: 71 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01229085
Sponsor's protocol ID: SALMOGLEN20906
Acronym: Psoriasis
Status last verified: Feb 2008
First submitted: 8 Feb 2008
Last updated: 27 Oct 2010
Results posted: No
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruitingPhase 2
Extension Study of Safety and Tolerability of DDY391 in Participants With Moderate to Severe Psoriatic Arthritis (CDDY391A12201-extension)
Moderate to Severe Psoriatic Arthritis
Recruiting
Efficacy of a Self-Management Smartphone App to Improve Safety Skills in Patients With Inflammatory Arthritis
Rhumatoid Arthisis, Spondyloarthritis (SA)
Active, not recruitingPhase 2
Dose Ranging Study of ORKA-001 in Patients With Moderate-to-Severe Plaque Psoriasis
Plaque Psoriasis
RecruitingPhase 1
A Study of HB0017 Injection in Healthy Volunteers to Evaluate Safety and Tolerability of a Single Subcutaneous Injection in Low-Body-Weight Subjects; and Pharmacokinetics at Different Subcutaneous Injection Sites at the Same Dose
Psoriasis, Ankylosing Spondylitis
RecruitingPhase 1
A Study to Learn if Bimekizumab Given in Different Ways is Safe and Moves Similarly Throughout the Body Over Time in Adults
Psoriatic Arthritis, Axial Spondyloarthritis

All Psoriasis trials

Study at a glance

From the registry record, last updated by the sponsor on 27 Oct 2010. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: CLINICAL ASSESSMENT OF THE EFFECTIVENESS OF ASSOCIATION MONETASONE FUROATE 0.1% SALICYLIC ACID AND 5% FOR SUBMISSION OF OINTMENT TOPICAL DERMATOLOGICAL USE OF LABORATORY Glenmark Pharmaceuticals Ltd, IN PATIENTS WITH PSORIASIS.
ClinicalTrials.gov ID: NCT01229085
Acronym / sponsor ID: Psoriasis / SALMOGLEN20906
Conditions: Psoriasis
Keywords: Psoriasis, mometasone, salicylic acid.
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 71 participants (actual)
Lead sponsor: Azidus BrasilIndustry (pharma, biotech, devices)
Study start: Sep 2006
Primary completion: Oct 2007 (actual)
Study completion: Oct 2007 (actual)
First posted: 27 Oct 2010 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Test	Experimental	Drug: memotasone + salicylic acidmometasone 0,1% + salicylic acid 5%

Who may qualify

Ages: 18 to 70 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

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);

Key exclusion criteria (7 listed)

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;

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
memotasone + salicylic acidmometasone 0,1% + salicylic acid 5%.	Drug	Test

Primary outcome

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.
Time frame: 45 days of treatment.
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.

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2010.

Related trials for Psoriasis

Not yet recruitingPhase 2
Extension Study of Safety and Tolerability of DDY391 in Participants With Moderate to Severe Psoriatic Arthritis (CDDY391A12201-extension)
Moderate to Severe Psoriatic Arthritis
Recruiting
Efficacy of a Self-Management Smartphone App to Improve Safety Skills in Patients With Inflammatory Arthritis
Rhumatoid Arthisis, Spondyloarthritis (SA)
Active, not recruitingPhase 2
Dose Ranging Study of ORKA-001 in Patients With Moderate-to-Severe Plaque Psoriasis
Plaque Psoriasis
RecruitingPhase 1
A Study of HB0017 Injection in Healthy Volunteers to Evaluate Safety and Tolerability of a Single Subcutaneous Injection in Low-Body-Weight Subjects; and Pharmacokinetics at Different Subcutaneous Injection Sites at the Same Dose
Psoriasis, Ankylosing Spondylitis
RecruitingPhase 1
A Study to Learn if Bimekizumab Given in Different Ways is Safe and Moves Similarly Throughout the Body Over Time in Adults
Psoriatic Arthritis, Axial Spondyloarthritis

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing memotasone + salicylic acid in people with Psoriasis, run by Azidus Brasil at 1 site in Brazil.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Oct 2010. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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. (time frame: 45 days of treatment.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01229085.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2010.