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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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2011 by L.A.L Clinica Pesquisa e Desenvolvimento Ltda..
Recruitment status was  Not yet recruiting
Information provided by:
L.A.L Clinica Pesquisa e Desenvolvimento Ltda. Identifier:
First received: April 8, 2010
Last updated: January 27, 2011
Last verified: January 2011

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.

Condition Intervention Phase
Drug: Dexamethasone + clemastine
Drug: Dexamethasone
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Resource links provided by NLM:

Further study details as provided by L.A.L Clinica Pesquisa e Desenvolvimento Ltda.:

Primary Outcome Measures:
  • 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. ] [ Designated as safety issue: No ]
    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.

Secondary Outcome Measures:
  • Evaluation of the efficacy. [ Time Frame: 14 days of treatment. ] [ Designated as safety issue: No ]
    Constitute secondary signals of efficacy including excoriation, oozing, crusting and lichenification.

Estimated Enrollment: 96
Study Start Date: March 2011
Estimated Study Completion Date: December 2011
Estimated Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Dexamethasone + Clemastine
Dexamethasone + clemastine fumarate cream
Drug: Dexamethasone + clemastine
Dexamethasone 0.5 mg clemastine fumarate: 01 tablet every 12 hours.
Active Comparator: Dexamethasone
Dexamethasone 0.5 mg
Drug: Dexamethasone
Dexamethasone 0.5 mg: 01 tablet every 12 hours.


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01239719

Contact: Alexandre Frederico, Physician 55 19 3829-3822

Sponsors and Collaborators
L.A.L Clinica Pesquisa e Desenvolvimento Ltda.
  More Information

No publications provided

Responsible Party: Alexandre Frederico, LAL Clínica Identifier: NCT01239719     History of Changes
Other Study ID Numbers: DECEMS11209, Version 02 - Amendment 02
Study First Received: April 8, 2010
Last Updated: January 27, 2011
Health Authority: Brazil: National Health Surveillance Agency

Keywords provided by L.A.L Clinica Pesquisa e Desenvolvimento Ltda.:
Allergic dermatitis

Additional relevant MeSH terms:
Dermatitis, Atopic
Genetic Diseases, Inborn
Hypersensitivity, Immediate
Immune System Diseases
Skin Diseases
Skin Diseases, Eczematous
Skin Diseases, Genetic
BB 1101
Dexamethasone 21-phosphate
Dexamethasone acetate
Anti-Allergic Agents
Anti-Inflammatory Agents
Antineoplastic Agents
Antineoplastic Agents, Hormonal
Autonomic Agents
Central Nervous System Agents
Dermatologic Agents
Enzyme Inhibitors
Gastrointestinal Agents
Histamine Agents
Histamine Antagonists
Histamine H1 Antagonists
Hormones processed this record on November 27, 2014