Cutaneous HypersensitivityPhase 3NCT01529242
Comparison of Desloratadine Associated With Prednisolone Oral Solution Versus Dexchlorpheniramine Associated With Betamethasone for Cutaneous Rash Treatment
A Phase 3 study testing Desloratadine + Prednisolone and Dexchlorpheniramine + Betamethasone in people with Cutaneous Hypersensitivity, run by EMS at 3 sites in Brazil.
Trial summary
The purpose of this study is to evaluate the non-inferiority clinical efficacy of two different drug associations in the treatment of acute cutaneous rash in children between 2 and 12 years old. Read more about this study
- Who is it for?
- Ages 2 to 11 years
- Conditions the study is for
- Cutaneous Hypersensitivity
- What is being tested?
- Desloratadine + Prednisolone and Dexchlorpheniramine + Betamethasone
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 3 sitesBrazil
- Study dates
- Feb 2014to 20 Oct 2016
- 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 2 to 11 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Consent of the patient or legal guardian;
- Clinical diagnosis of acute cutaneous rash defined by the presence of erythematous papules on healthy skin, different sizes, itchy and fleeting
- Children aged between 2 and 11 years and 11 months (up to 30 kg);
Who cannot join
- Participation in clinical trial in 30 days prior to study entry;
- Patients with history of hypersensitivity to desloratadine or prednisolone or with corticosteroids use contraindications ;
- Patients with any clinically significant disease other than cutaneous rash including hematopoietic, cardiovascular, renal, neurological, psychiatric or autoimmune disorders;
- Patients on treatment with monoamine oxidase inhibitors (MAOIs);
- Patients diagnosed with other dermatoses
Trial locations and contacts
3 sites in 1 country.
Brazil3 sites
Allergisa
Campinas, São Paulo
Alergoalpha
São Paulo, São Paulo
Hospital Nipo Brasileiro
São Paulo, São Paulo
About this study
Official title: A Double-blind, Randomized, Multicenter Parallel-group Study on Efficacy of Desloratadine and Prednisolone Association Compared to Dexchlorpheniramine and Betamethasone Association in Children (2-12 Years) With Acute Cutaneous Rash
The purpose of this study is to evaluate the non-inferiority clinical efficacy of two different drug associations in the treatment of acute cutaneous rash in children between 2 and 12 years old.
Read the detailed description
- double-blind, non-inferiority, prospective, parallel group trial.
- Experiment duration: 05 days.
- 03 visits (day 0, 48 hours and day 5).
- Efficacy will be evaluated for acute cutaneous rash based on symptoms score
- Adverse events evaluation.
- Conditions
- Cutaneous Hypersensitivity
- Being tested
- Desloratadine + Prednisolone, Dexchlorpheniramine + Betamethasone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Desloratadine + PrednisoloneDrug
Children (2 to 5 years): 2.5 ml 3 times a day Children (6 to 12 years): 5.0 ml 3 times a day
Dexchlorpheniramine + BetamethasoneDrug
Children (2 to 5 years): 2.5 ml 3 times a day Children (6 to 12 years): 5.0 ml 3 times a day
| Study group | Role | What they receive |
|---|---|---|
| Desloratadine + Prednisolone | Experimental | desloratadine 0,5 mg/ml + prednisolone 4 mg/ml - oral solution Receives: Drug: Desloratadine + Prednisolone |
| Dexchlorpheniramine + Betamethasone | Active comparator | dexchlorpheniramine maleate 0,4 mg/ml + Betamethasone 0,05 mg/ml - oral solution Receives: Drug: Dexchlorpheniramine + Betamethasone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy of treatment in acute cutaneous rash based on symptoms score
The differences in the intensity of signs and symptoms of acute cutaneous rash between the beginning and end of the study will be used as the primary endpoint of clinical efficacy
.
Measured: 5 days
Secondary outcomes (1)
Safety will be evaluated by the adverse event occurrences
Adverse events will be recorded and followed in order to evaluate safety and tolerability
Measured: 5 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2012 (estimated)
- Study startFeb 2014
- Primary completionAug 2016
- Study completion20 Oct 2016
Why it stopped: By sponsor decision due to difficulty of recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cutaneous HypersensitivityStudies 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
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- EMS
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Dirceu Solé, MD, Principal investigator, Federal University of São Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01529242
- Sponsor's protocol ID
- DPUEMS1111
- Status last verified
- Feb 2017
- First submitted
- 6 Feb 2012
- Last updated
- 16 Feb 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-blind, Randomized, Multicenter Parallel-group Study on Efficacy of Desloratadine and Prednisolone Association Compared to Dexchlorpheniramine and Betamethasone Association in Children (2-12 Years) With Acute Cutaneous Rash
- ClinicalTrials.gov ID
- NCT01529242
- Acronym / sponsor ID
- DPUEMS1111
- Conditions
- Cutaneous Hypersensitivity
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: By sponsor decision due to difficulty of recruitment
- Enrolment
- 17 participants (actual)
- Lead sponsor
- EMSIndustry (pharma, biotech, devices)
- Study start
- Feb 2014 (actual)
- Primary completion
- Aug 2016 (actual)
- Study completion
- 20 Oct 2016 (actual)
- First posted
- 8 Feb 2012 (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 purpose of this study is to evaluate the non-inferiority clinical efficacy of two different drug associations in the treatment of acute cutaneous rash in children between 2 and 12 years old.
Detailed description
- double-blind, non-inferiority, prospective, parallel group trial.
- Experiment duration: 05 days.
- 03 visits (day 0, 48 hours and day 5).
- Efficacy will be evaluated for acute cutaneous rash based on symptoms score
- Adverse events evaluation.
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 |
|---|---|---|
| Desloratadine + Prednisolone | Experimental | Drug: Desloratadine + Prednisolonedesloratadine 0,5 mg/ml + prednisolone 4 mg/ml - oral solution |
| Dexchlorpheniramine + Betamethasone | Active comparator | Drug: Dexchlorpheniramine + Betamethasonedexchlorpheniramine maleate 0,4 mg/ml + Betamethasone 0,05 mg/ml - oral solution |
Who may qualify
- Ages
- 2 to 11 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Consent of the patient or legal guardian;
- Clinical diagnosis of acute cutaneous rash defined by the presence of erythematous papules on healthy skin, different sizes, itchy and fleeting
- Children aged between 2 and 11 years and 11 months (up to 30 kg);
Key exclusion criteria (5 listed)
- Participation in clinical trial in 30 days prior to study entry;
- Patients with history of hypersensitivity to desloratadine or prednisolone or with corticosteroids use contraindications ;
- Patients with any clinically significant disease other than cutaneous rash including hematopoietic, cardiovascular, renal, neurological, psychiatric or autoimmune disorders;
- Patients on treatment with monoamine oxidase inhibitors (MAOIs);
- Patients diagnosed with other dermatoses
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 |
|---|---|---|
| Desloratadine + PrednisoloneChildren (2 to 5 years): 2.5 ml 3 times a day Children (6 to 12 years): 5.0 ml 3 times a day | Drug | Desloratadine + Prednisolone |
| Dexchlorpheniramine + BetamethasoneChildren (2 to 5 years): 2.5 ml 3 times a day Children (6 to 12 years): 5.0 ml 3 times a day | Drug | Dexchlorpheniramine + Betamethasone |
Primary outcome
Efficacy of treatment in acute cutaneous rash based on symptoms score
Time frame: 5 days
The differences in the intensity of signs and symptoms of acute cutaneous rash between the beginning and end of the study will be used as the primary endpoint of clinical efficacy .
1 secondary outcome
Safety will be evaluated by the adverse event occurrences
Time frame: 5 days
Results and safety
The study was stopped early (reason given: By sponsor decision due to difficulty of recruitment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Feb 2017.
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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.
Dirceu Solé, MD principal investigator
Federal University of São Paulo
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Desloratadine + Prednisolone and Dexchlorpheniramine + Betamethasone in people with Cutaneous Hypersensitivity, run by EMS at 3 sites 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 3 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: stopped early, as of the sponsor's last update on 16 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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 was stopped early (reason given: By sponsor decision due to difficulty of recruitment). 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?
Efficacy of treatment in acute cutaneous rash based on symptoms score (time frame: 5 days). 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 16 Feb 2017.