EczemaPhase 3NCT01429701
Effectiveness of Polymyxin B Sulphate + Prednisolone + Benzocaine + Clioquinol in Acute and Sub-acute Dermatitis Eczematous
A Phase 3 study testing polymyxin B sulphate + prednisolone + benzocaine + clioquinol and betamethasone + gentamicin + tolnaftato + cleoquinol in people with Eczema, run by EMS.
Trial summary
Dermatitis eczematous is a recurrent pruritic skin disorder which has a significant morbidity and impaired quality of life due specially pruritus and physical visible skin lesions. The purpose of this trial is evaluate the effectiveness of two different topic associations of drugs. Read more about this study
- Who is it for?
- Ages 18 to 40 years
- Conditions the study is for
- Eczema
- What is being tested?
- polymyxin B sulphate + prednisolone + benzocaine + clioquinol and betamethasone + gentamicin + tolnaftato + cleoquinol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 76 participants
- Where
- No sites listed yet
- Study dates
- May 2012to Aug 2012
- 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 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients must be able to understand the study procedures agree to participate and give written consent.
- Patients with acute or subacute dermatitis with a minimum of 3 symptoms.
Who cannot join
- Pregnancy or risk of pregnancy.
- Lactation
- Use of anti-inflammatory or immunosuppressive drugs (last 30 days prior to the study).
- Sunlight over exposure in the last 15 days.
- Any pathology or past medical condition that can interfere with this protocol.
About this study
Official title: Unicentric Comparing Effectiveness of Polymyxin B Sulphate + Prednisolone + Benzocaine + Clioquinol to Betamethasone + Gentamicin + Tolnaftate + Clioquinol in Acute and Sub-acute Dermatitis Eczematous
Dermatitis eczematous is a recurrent pruritic skin disorder which has a significant morbidity and impaired quality of life due specially pruritus and physical visible skin lesions. The purpose of this trial is evaluate the effectiveness of two different topic associations of drugs.
Read the detailed description
Study design:
- Experiment duration: 22 days
- 2 visits (days 0,7,15 and 22)
- Reducing eczema area and severity index evaluation
- Adverse events evaluation
- Double blinded, non-inferiority, prospective parallel-group, intend to treat trial.
- Conditions
- Eczema
- Being tested
- polymyxin B sulphate + prednisolone + benzocaine + clioquinol, betamethasone + gentamicin + tolnaftato + cleoquinol
- Keywords
- Dermatitis, Dermatitis, Atopic
- Medical subject headings
- Eczema, Dermatitis, Dermatitis, Atopic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
polymyxin B sulphate + prednisolone + benzocaine + clioquinolDrug
applied 3 times / day at lesion
betamethasone + gentamicin + tolnaftato + cleoquinolDrug
applied 3 times / day at lesion
| Study group | Role | What they receive |
|---|---|---|
| Test association cream | Experimental | polymyxin B sulphate + prednisolone + benzocaine + clioquinol Receives: Drug: polymyxin B sulphate + prednisolone + benzocaine + clioquinol |
| Comparative association cream | Active comparator | betamethasone + gentamicin + tolnaftato + clioquinol Receives: Drug: betamethasone + gentamicin + tolnaftato + cleoquinol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction / improvement of signs and symptoms
The reduction of signs and symptoms will be evaluated by OSAAD index.
Measured: DAY 22
Secondary outcomes (1)
Adverse Events Evaluation
Adverse events will be collected and followed in order to evaluate safety and tolerability.
Measured: DAY 22
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2011 (estimated)
- Study startMay 2012
- Primary completionJun 2012
- Study completionAug 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EczemaStudies of the same condition, open and under way.
- More trials run by EMSThe sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 76 participants (actual)
Sponsor and investigators
- Lead sponsor
- EMS
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Flávia Addór, MD., Principal investigator, Medicin Instituto da Pele
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01429701
- Sponsor's protocol ID
- PREEMS0711
- Status last verified
- Mar 2013
- First submitted
- 5 Sep 2011
- Last updated
- 24 Feb 2021
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Unicentric Comparing Effectiveness of Polymyxin B Sulphate + Prednisolone + Benzocaine + Clioquinol to Betamethasone + Gentamicin + Tolnaftate + Clioquinol in Acute and Sub-acute Dermatitis Eczematous
- ClinicalTrials.gov ID
- NCT01429701
- Acronym / sponsor ID
- PREEMS0711
- Conditions
- Eczema
- Keywords
- Dermatitis, Dermatitis, Atopic
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 76 participants (actual)
- Lead sponsor
- EMSIndustry (pharma, biotech, devices)
- Study start
- May 2012
- Primary completion
- Jun 2012 (actual)
- Study completion
- Aug 2012 (actual)
- First posted
- 7 Sep 2011 (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.
Dermatitis eczematous is a recurrent pruritic skin disorder which has a significant morbidity and impaired quality of life due specially pruritus and physical visible skin lesions. The purpose of this trial is evaluate the effectiveness of two different topic associations of drugs.
Detailed description
Study design:
- Experiment duration: 22 days
- 2 visits (days 0,7,15 and 22)
- Reducing eczema area and severity index evaluation
- Adverse events evaluation
- Double blinded, non-inferiority, prospective parallel-group, intend to treat trial.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Test association cream | Experimental | Drug: polymyxin B sulphate + prednisolone + benzocaine + clioquinolpolymyxin B sulphate + prednisolone + benzocaine + clioquinol |
| Comparative association cream | Active comparator | Drug: betamethasone + gentamicin + tolnaftato + cleoquinolbetamethasone + gentamicin + tolnaftato + clioquinol |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Patients must be able to understand the study procedures agree to participate and give written consent.
- Patients with acute or subacute dermatitis with a minimum of 3 symptoms.
Key exclusion criteria (5 listed)
- Pregnancy or risk of pregnancy.
- Lactation
- Use of anti-inflammatory or immunosuppressive drugs (last 30 days prior to the study).
- Sunlight over exposure in the last 15 days.
- Any pathology or past medical condition that can interfere with this protocol.
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 |
|---|---|---|
| polymyxin B sulphate + prednisolone + benzocaine + clioquinolapplied 3 times / day at lesion | Drug | Test association cream |
| betamethasone + gentamicin + tolnaftato + cleoquinolapplied 3 times / day at lesion | Drug | Comparative association cream |
Primary outcome
Reduction / improvement of signs and symptoms
Time frame: DAY 22
The reduction of signs and symptoms will be evaluated by OSAAD index.
1 secondary outcome
Adverse Events Evaluation
Time frame: DAY 22
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 24 Feb 2021.
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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.
Flávia Addór, MD. principal investigator
Medicin Instituto da Pele
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing polymyxin B sulphate + prednisolone + benzocaine + clioquinol and betamethasone + gentamicin + tolnaftato + cleoquinol in people with Eczema, run by EMS.
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 2 inclusion and 5 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 24 Feb 2021. 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 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?
Reduction / improvement of signs and symptoms (time frame: DAY 22). 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 24 Feb 2021.