- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01239719
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
January 27, 2011 updated by: Azidus Brasil
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 Overview
Status
Unknown
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
96
Phase
- Phase 3
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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
- drug eruption
- allergic vasculitis
- dyshidrosis, Note: The above clinical conditions are diagnosed from clinical examination.
Exclusion Criteria:
- 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
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Dexamethasone + Clemastine
Dexamethasone + clemastine fumarate cream
|
Dexamethasone 0.5 mg clemastine fumarate: 01 tablet every 12 hours.
|
ACTIVE_COMPARATOR: Dexamethasone
Dexamethasone 0.5 mg
|
Dexamethasone 0.5 mg: 01 tablet every 12 hours.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
14 days of treatment.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Evaluation of the efficacy.
Time Frame: 14 days of treatment.
|
Constitute secondary signals of efficacy including excoriation, oozing, crusting and lichenification.
|
14 days of treatment.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2011
Primary Completion (ANTICIPATED)
July 1, 2011
Study Completion (ANTICIPATED)
December 1, 2011
Study Registration Dates
First Submitted
April 8, 2010
First Submitted That Met QC Criteria
November 10, 2010
First Posted (ESTIMATE)
November 11, 2010
Study Record Updates
Last Update Posted (ESTIMATE)
January 28, 2011
Last Update Submitted That Met QC Criteria
January 27, 2011
Last Verified
January 1, 2011
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Skin Diseases
- Dermatitis
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Autonomic Agents
- Peripheral Nervous System Agents
- Enzyme Inhibitors
- Anti-Inflammatory Agents
- Antineoplastic Agents
- Antiemetics
- Gastrointestinal Agents
- Glucocorticoids
- Hormones
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Antineoplastic Agents, Hormonal
- Protease Inhibitors
- Dermatologic Agents
- Anti-Allergic Agents
- Histamine H1 Antagonists
- Histamine Antagonists
- Histamine Agents
- Antipruritics
- Dexamethasone
- Dexamethasone acetate
- BB 1101
- Clemastine
Other Study ID Numbers
- DECEMS11209
- Version 02 - Amendment 02
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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