Plaque PsoriasisPhase 2PsoriasisNCT01228656
Effectiveness of Association Mometasone Furoate 0.1% and Salicylic Acid 5% Compared With Mometasone Furoate
A Phase 2 study testing mometasone furoate + salicylic acid and Mometasone furoate in people with Plaque Psoriasis, run by Azidus Brasil.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Plaque Psoriasis
- What is being tested?
- mometasone furoate + salicylic acid and Mometasone furoate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- Sep 2006to Oct 2011
- Phase
- Phase 2
- 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 65 years
- All sexes
- Healthy volunteers accepted
- 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;
- 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.
Who cannot join
- 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.
About this study
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
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.
Read the 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
- Being tested
- mometasone furoate + salicylic acid, Mometasone furoate
- Keywords
- Psoriasis
- Medical subject headings
- Psoriasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mometasone furoate + salicylic acidDrug
Dermatologic ointment applied once a day.
Mometasone furoateDrug
Dermatologic ointment applied once a day
| Study group | Role | What they receive |
|---|---|---|
| -mometasone furoate associated with salicylic acid | Experimental | Not described Receives: Drug: mometasone furoate + salicylic acid |
| -mometasone furoate | Active comparator | Not described Receives: Drug: Mometasone furoate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluating the effectiveness and comparative isolation of the association mometasone furoate + salicylic acid and the substance isolated mometasone furoate
Measured: 2 months of treatment.
Secondary outcomes (1)
Evaluation by means of analytical propedeutics medical improvement in clinical signs and symptoms related to plaque psoriasis.
Measured: 2 months of treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2010 (estimated)
- Study startSep 2006
- Primary completionOct 2010
- Study completionOct 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Plaque 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Azidus Brasil
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Principal investigator, Azidus Brasil, Azidus Brasil
- Investigators
- Alexandre Frederico, Doctor, Principal investigator, LAL Clinical Reseach e Development Ltda
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01228656
- Sponsor's protocol ID
- SALMOGLEN10906
- Other IDs
- Psoriasis
- Acronym
- Psoriasis
- Status last verified
- Nov 2022
- First submitted
- 7 Feb 2008
- Last updated
- 3 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01228656
- Acronym / sponsor ID
- Psoriasis / SALMOGLEN10906
- Conditions
- Plaque Psoriasis
- Keywords
- Psoriasis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Suspended
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Azidus BrasilIndustry (pharma, biotech, devices)
- Study start
- Sep 2006 (actual)
- Primary completion
- Oct 2010 (actual)
- Study completion
- Oct 2011
- First posted
- 26 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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| -mometasone furoate associated with salicylic acid | Experimental | Drug: mometasone furoate + salicylic acid |
| -mometasone furoate | Active comparator | Drug: Mometasone furoate |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- 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;
- Patients with plaque psoriasis of mild to moderate;
- Patients who agree to participate and sign the Informed Consent and
- Clarified (appendix);
Key exclusion criteria (8 listed)
- 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;
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 |
|---|---|---|
| mometasone furoate + salicylic acidDermatologic ointment applied once a day. | Drug | -mometasone furoate associated with salicylic acid |
| Mometasone furoateDermatologic ointment applied once a day | Drug | -mometasone furoate |
Primary outcome
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.
1 secondary outcome
Evaluation by means of analytical propedeutics medical improvement in clinical signs and symptoms related to plaque psoriasis.
Time frame: 2 months of treatment.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2022.
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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.
Alexandre Frederico, Doctor principal investigator
LAL Clinical Reseach e Development Ltda
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing mometasone furoate + salicylic acid and Mometasone furoate in people with Plaque Psoriasis, run by Azidus Brasil.
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 8 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: paused, as of the sponsor's last update on 3 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
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?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 3 Nov 2022.