DermatitisPhase 3NCT01125761
Efficacy and Safety of the Association Drugs in Patients With Allergic Dermatitis
A Phase 3 study testing dexamethasone 0.5 mg and 1.0 mg clemastine cream and Dexamethasone 0,5 mg cream in people with Dermatitis, run by Azidus Brasil at 2 sites in Brazil.
Trial summary
Considering the pathogenesis of several allergic skin diseases to be investigated in this study as well as the pharmacodynamic mechanisms of the association of dexamethasone and clemastine fumarate, it is believed that the components of topical medication may act synergistically in the reduction of signs and symptoms… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dermatitis
- What is being tested?
- dexamethasone 0.5 mg and 1.0 mg clemastine cream and Dexamethasone 0,5 mg cream
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 2 sitesBrazil
- Study dates
- Nov 2010to Nov 2010
- 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 Deed of Consent (IC) in two ways, by his own free will, agreeing with all study procedures;
- Patients older than 18 years, any ethnicity, class or social group, regardless of sex;
- Patients with pictures of dermatoses acute, subacute or chronic, of inflammatory origin and / or allergic, to which it is recommended the use of drugs under investigation topically, such as:
- atopic dermatitis,
- prurigo,
- primary contact dermatitis or allergic
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- urticaria,
- pharmacodermic,
- allergic vasculitis,
- dyshidrosis,
Who cannot join
- Patients being treated with antibiotics;
- Participation in clinical trials in the 12 months preceding the survey;
- Current treatment with immunosuppressants (eg, cyclosporine or methotrexate);
- Current treatment with phototherapy (UVA, UVB, PUVA and lasers);
- Use of systemic corticosteroids at inclusion visit or within 15 days prior to inclusion;
- Topical treatments at the site of acne in the 15 days preceding the visit of inclusion;
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- Presence of any skin condition in areas affected by acne that hamper the evolutionary analysis of the lesion;
- Presence of secondary infections at the site of treatment, diagnosed clinically;
- Presence of other eczematous picture, such as nummular eczema, neurodermatitis, seborrheic dermatitis, psoriasis, scabies, and Buckley's syndrome Wiskott-Aldrich;
- Pregnant or lactating women;
- Chronic alcoholism;
- Patients with a history of hypersensitivity to any component of the formulas 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 of moderate or severe that, according to the investigator, is not justified topical.
Trial locations and contacts
2 sites in 1 country.
Brazil2 sites
LAL Clinica Pesquisa e Desenvolvimento Ltda
Valinhos, São Paulo, 13276-245
LAL Clínica Pesquisa e Desenvolvimento Ltda
Valinhos, São Paulo, 13276-245
About this study
Official title: Efficacy and Safety of the Association of Dexamethasone 0.5 mg + Clemastine Fumarate 1 mg When Compared to Dexamethasone 0.5 mg in Patients With Allergic Dermatitis
Considering the pathogenesis of several allergic skin diseases to be investigated in this study as well as the pharmacodynamic mechanisms of the association of dexamethasone and clemastine fumarate, it is believed that the components of topical medication may act synergistically in the reduction of signs and symptoms of the diseases in question. Therefore it is expected that the association promotes results significantly superior to dexamethasone alone.
- Conditions
- Dermatitis
- Being tested
- dexamethasone 0.5 mg and 1.0 mg clemastine cream, Dexamethasone 0,5 mg cream
- Keywords
- Allergic dermatitis
- Medical subject headings
- Dermatitis, Dermatitis, Atopic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dexamethasone 0.5 mg and 1.0 mg clemastine creamDrug
The treatment should be administered every 12 hours so that a thin layer is applied on the lesions, for 14 days.
Dexamethasone 0,5 mg creamDrug
The treatment should be administered every 12 hours so that a thin layer is applied on the lesions, for 14 days.
| Study group | Role | What they receive |
|---|---|---|
| dexamethasone 0.5 mg and 1.0 mg clemastine cream | Experimental | Not described Receives: Drug: dexamethasone 0.5 mg and 1.0 mg clemastine cream |
| dexamethasone 0,5 mg cream | Active comparator | Not described Receives: Drug: Dexamethasone 0,5 mg cream |
What is being measured
The primary outcome is the main question the study is designed to answer.
Through clinical examinations, evaluating the efficacy of the cream composed by 0.5 mg dexamethasone and clemastine 1mg compared with the cream of 0.5 mg dexamethasone in improving the signs and symptoms associated with allergic dermatitis.
Measured: 14 days
Secondary outcomes (8)
Improvement of the erythema associated with allergic dermatitis.
Measured: 14 days
Improvement of the edema associated with allergic dermatitis.
Measured: 14 days
Improvement of the extension of lesion associated with allergic dermatitis.
Measured: 14 days
Evaluate, through clinical examinations, the effectiveness of the drug association in reducing excoriation associated with allergic dermatitis.
Measured: 14 days
Evaluate, through clinical examinations, the effectiveness of the drug association in reducing exudation associated with allergic dermatitis.
Measured: 14 dyas
Evaluate, through clinical examinations, the effectiveness of the drug association in reducing of scabbing associated with allergic dermatitis.
Measured: 14 days
Evaluate, through clinical examinations, the effectiveness of the drug association in reducing of lichenification associated with allergic dermatitis.
Measured: 14 days
Evaluate the safety of the formulations in relation to the occurrence, type, frequency and intensity of adverse events during treatment.
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2010 (estimated)
- Study startNov 2010
- Primary completionNov 2010 (estimated)
- Study completionNov 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DermatitisStudies 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
- Single blind
- Who is masked
- Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Azidus Brasil
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Principal investigator, Azidus Brasil, Azidus Brasil
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01125761
- Sponsor's protocol ID
- DECEMS21209
- Status last verified
- Nov 2022
- First submitted
- 17 May 2010
- 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
- Efficacy and Safety of the Association of Dexamethasone 0.5 mg + Clemastine Fumarate 1 mg When Compared to Dexamethasone 0.5 mg in Patients With Allergic Dermatitis
- ClinicalTrials.gov ID
- NCT01125761
- Acronym / sponsor ID
- DECEMS21209
- Conditions
- Dermatitis
- Keywords
- Allergic dermatitis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Azidus BrasilIndustry (pharma, biotech, devices)
- Study start
- Nov 2010
- Primary completion
- Nov 2010 (estimated)
- Study completion
- Nov 2010
- First posted
- 18 May 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.
Considering the pathogenesis of several allergic skin diseases to be investigated in this study as well as the pharmacodynamic mechanisms of the association of dexamethasone and clemastine fumarate, it is believed that the components of topical medication may act synergistically in the reduction of signs and symptoms of the diseases in question. Therefore it is expected that the association promotes results significantly superior to dexamethasone alone.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| dexamethasone 0.5 mg and 1.0 mg clemastine cream | Experimental | Drug: dexamethasone 0.5 mg and 1.0 mg clemastine cream |
| dexamethasone 0,5 mg cream | Active comparator | Drug: Dexamethasone 0,5 mg cream |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Patients who sign the Deed of Consent (IC) in two ways, by his own free will, agreeing with all study procedures;
- atopic dermatitis,
- prurigo,
- primary contact dermatitis or allergic
- urticaria,
Key exclusion criteria (14 listed)
- Patients being treated with antibiotics;
- Participation in clinical trials in the 12 months preceding the survey;
- Current treatment with immunosuppressants (eg, cyclosporine or methotrexate);
- Current treatment with phototherapy (UVA, UVB, PUVA and lasers);
- Use of systemic corticosteroids at inclusion visit or within 15 days prior to inclusion;
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 0.5 mg and 1.0 mg clemastine creamThe treatment should be administered every 12 hours so that a thin layer is applied on the lesions, for 14 days. | Drug | dexamethasone 0.5 mg and 1.0 mg clemastine cream |
| Dexamethasone 0,5 mg creamThe treatment should be administered every 12 hours so that a thin layer is applied on the lesions, for 14 days. | Drug | dexamethasone 0,5 mg cream |
Primary outcome
Through clinical examinations, evaluating the efficacy of the cream composed by 0.5 mg dexamethasone and clemastine 1mg compared with the cream of 0.5 mg dexamethasone in improving the signs and symptoms associated with allergic dermatitis.
Time frame: 14 days
8 secondary outcomes
Improvement of the erythema associated with allergic dermatitis.
Time frame: 14 days
Improvement of the edema associated with allergic dermatitis.
Time frame: 14 days
Improvement of the extension of lesion associated with allergic dermatitis.
Time frame: 14 days
Evaluate, through clinical examinations, the effectiveness of the drug association in reducing excoriation associated with allergic dermatitis.
Time frame: 14 days
Evaluate, through clinical examinations, the effectiveness of the drug association in reducing exudation associated with allergic dermatitis.
Time frame: 14 dyas
Evaluate, through clinical examinations, the effectiveness of the drug association in reducing of scabbing associated with allergic dermatitis.
Time frame: 14 days
Evaluate, through clinical examinations, the effectiveness of the drug association in reducing of lichenification associated with allergic dermatitis.
Time frame: 14 days
Evaluate the safety of the formulations in relation to the occurrence, type, frequency and intensity of adverse events during treatment.
Time frame: 14 days
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
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.
The record lists no contact. Use the official record to reach the sponsor.
2 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 dexamethasone 0.5 mg and 1.0 mg clemastine cream and Dexamethasone 0,5 mg cream in people with Dermatitis, run by Azidus Brasil at 2 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 10 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: withdrawn, 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.
Where is the study taking place?
The record lists 2 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 withdrawn before enrolling participants, so there are no results.
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?
Through clinical examinations, evaluating the efficacy of the cream composed by 0.5 mg dexamethasone and clemastine 1mg compared with the cream of 0.5 mg dexamethasone in improving the signs and symptoms associated with allergic dermatitis. (time frame: 14 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 3 Nov 2022.