AllergyPhase 3NCT01239719
Randomized Study for Effectiveness and Safety Evaluation of Dexamethasone 0.5 mg + Fumarate Clemastine 1 mg Compared to Dexamethasone 0.5 mg in Patients With Allergic Dermatitis
A Phase 3 study testing Dexamethasone + clemastine and Dexamethasone in people with Allergy and Dermatitis, run by Azidus Brasil.
Trial summary
The aim of this study is to prove the efficacy of the dexamethasone 0.5 mg + 1 mg clemastine fumarate tablet compared to 0.5 mg of dexamethasone in reducing the signs and symptoms of allergic dermatitis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Allergy, Dermatitis
- What is being tested?
- Dexamethasone + clemastine and Dexamethasone
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 96 participants
- Where
- No sites listed yet
- Study dates
- Mar 2011to Dec 2011
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients who sign the IC in two ways, agreeing with all study procedures
- Patients aged above 18 years of any ethnicity, class or social group, female or male
- Patients with acute, subacute or chronic dermatoses, of inflammatory and / or allergic origin, to which it is recommended the use of drugs under investigation, such as:
- atopic dermatitis
- prurigo
- primary contact dermatitis or allergic hives
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- drug eruption
- allergic vasculitis
- dyshidrosis, Note: The above clinical conditions are diagnosed from clinical examination.
Who cannot join
- Patients being treated with antibiotics
- Participation in clinical trials in the 12 months preceding the investigation
- Current treatment with immunosuppressants (eg, cyclosporine or methotrexate)
- Current treatment with phototherapy (UVA, UVB, PUVA and lasers)
- Use of systemic corticosteroids in the visit to include or 15 days preceding the survey
- Topical treatments at the site of lesions in the 15 days preceding the survey
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- Presence of any skin condition
- Presence of secondary infections at the site of treatment, diagnosed clinically;
- Presence of other eczematous diseases, such as nummular eczema, neurodermatitis, seborrheic dermatitis, psoriasis, scabies, and Buckley's syndrome
- Pregnant or lactating women
- Chronic alcoholism
- Patients with a history of hypersensitivity to any component of the products under investigation.
- Any finding of clinical observation (clinical history or physical examination) that is interpreted by the physician investigator as a risk to the patient's participation in the study.
- Allergic Dermatosis mild or, acording to the investigator criteria, is not justified systemic treatment.
Trial locations and contacts
No sites are listed yet.
About this study
The aim of this study is to prove the efficacy of the dexamethasone 0.5 mg + 1 mg clemastine fumarate tablet compared to 0.5 mg of dexamethasone in reducing the signs and symptoms of allergic dermatitis.
- Conditions
- Allergy, Dermatitis
- Being tested
- Dexamethasone + clemastine, Dexamethasone
- Keywords
- Allergic dermatitis
- Medical subject headings
- Hypersensitivity, Dermatitis, Dermatitis, Atopic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dexamethasone + clemastineDrug
Dexamethasone 0.5 mg clemastine fumarate: 01 tablet every 12 hours.
DexamethasoneDrug
Dexamethasone 0.5 mg: 01 tablet every 12 hours.
| Study group | Role | What they receive |
|---|---|---|
| Dexamethasone + Clemastine | Experimental | Dexamethasone + clemastine fumarate cream Receives: Drug: Dexamethasone + clemastine |
| Dexamethasone | Active comparator | Dexamethasone 0.5 mg Receives: Drug: Dexamethasone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate, through clinical examinations, the effectiveness of the combination tablet with 0.5 mg of dexamethasone and clemastine 1 mg, compared with 0.5 mg tablet of dexamethasone in improving the signs and symptoms associated with allergic dermatitis.
Evaluating the effectiveness of the polypill dexamethasone 0.5 mg + 1 mg clemastine fumarate tablet compared to 0.5 mg of dexamethasone in improvement of signs (erythema, edema and lesion length) and symptoms (itching) associated with frames of dermatoses allergic.
Measured: 14 days of treatment.
Secondary outcomes (1)
Evaluation of the efficacy.
Constitute secondary signals of efficacy including excoriation, oozing, crusting and lichenification.
Measured: 14 days of treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Nov 2010 (estimated)
- Study startMar 2011
- Primary completionJul 2011 (estimated)
- Study completionDec 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AllergyStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 96 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Azidus Brasil
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01239719
- Sponsor's protocol ID
- DECEMS11209
- Other IDs
- Version 02 - Amendment 02
- Status last verified
- Jan 2011
- First submitted
- 8 Apr 2010
- Last updated
- 28 Jan 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Study for Effectiveness and Safety Evaluation of Dexamethasone 0.5 mg + Fumarate Clemastine 1 mg Compared to Dexamethasone 0.5 mg in Patients With Allergic Dermatitis
- ClinicalTrials.gov ID
- NCT01239719
- Acronym / sponsor ID
- DECEMS11209
- Conditions
- Allergy, Dermatitis
- Keywords
- Allergic dermatitis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 96 participants (estimated)
- Lead sponsor
- Azidus BrasilIndustry (pharma, biotech, devices)
- Study start
- Mar 2011
- Primary completion
- Jul 2011 (estimated)
- Study completion
- Dec 2011 (estimated)
- First posted
- 11 Nov 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 aim of this study is to prove the efficacy of the dexamethasone 0.5 mg + 1 mg clemastine fumarate tablet compared to 0.5 mg of dexamethasone in reducing the signs and symptoms of allergic dermatitis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dexamethasone + Clemastine | Experimental | Drug: Dexamethasone + clemastineDexamethasone + clemastine fumarate cream |
| Dexamethasone | Active comparator | Drug: DexamethasoneDexamethasone 0.5 mg |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Patients who sign the IC in two ways, agreeing with all study procedures
- Patients aged above 18 years of any ethnicity, class or social group, female or male
- Patients with acute, subacute or chronic dermatoses, of inflammatory and / or allergic origin, to which it is recommended the use of drugs under investigation, such as:
Key exclusion criteria (14 listed)
- Patients being treated with antibiotics
- Participation in clinical trials in the 12 months preceding the investigation
- Current treatment with immunosuppressants (eg, cyclosporine or methotrexate)
- Current treatment with phototherapy (UVA, UVB, PUVA and lasers)
- Use of systemic corticosteroids in the visit to include or 15 days preceding the survey
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 |
|---|---|---|
| Dexamethasone + clemastineDexamethasone 0.5 mg clemastine fumarate: 01 tablet every 12 hours. | Drug | Dexamethasone + Clemastine |
| DexamethasoneDexamethasone 0.5 mg: 01 tablet every 12 hours. | Drug | Dexamethasone |
Primary outcome
Evaluate, through clinical examinations, the effectiveness of the combination tablet with 0.5 mg of dexamethasone and clemastine 1 mg, compared with 0.5 mg tablet of dexamethasone in improving the signs and symptoms associated with allergic dermatitis.
Time frame: 14 days of treatment.
Evaluating the effectiveness of the polypill dexamethasone 0.5 mg + 1 mg clemastine fumarate tablet compared to 0.5 mg of dexamethasone in improvement of signs (erythema, edema and lesion length) and symptoms (itching) associated with frames of dermatoses allergic.
1 secondary outcome
Evaluation of the efficacy.
Time frame: 14 days of treatment.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2011.
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Dexamethasone + clemastine and Dexamethasone in people with Allergy and Dermatitis, 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 9 inclusion and 14 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: status not confirmed, as of the sponsor's last update on 28 Jan 2011. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Alexandre Frederico, Physician (55 19 3829-3822, alexandre@lalclinica.com.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluate, through clinical examinations, the effectiveness of the combination tablet with 0.5 mg of dexamethasone and clemastine 1 mg, compared with 0.5 mg tablet of dexamethasone in improving the signs and symptoms associated with allergic dermatitis. (time frame: 14 days 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 28 Jan 2011.