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

This study has been withdrawn prior to enrollment.
Sponsor:
Information provided by:
L.A.L Clinica Pesquisa e Desenvolvimento Ltda.
ClinicalTrials.gov Identifier:
NCT01125761
First received: May 17, 2010
Last updated: October 25, 2010
Last verified: April 2010
  Purpose

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.


Condition Intervention Phase
Dermatitis
Drug: dexamethasone 0.5 mg and 1.0 mg clemastine cream
Drug: Dexamethasone 0,5 mg cream
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment

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

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

Secondary Outcome Measures:
  • Improvement of the erythema associated with allergic dermatitis. [ Time Frame: 14 days ] [ Designated as safety issue: No ]
  • Improvement of the edema associated with allergic dermatitis. [ Time Frame: 14 days ] [ Designated as safety issue: No ]
  • Improvement of the extension of lesion associated with allergic dermatitis. [ Time Frame: 14 days ] [ Designated as safety issue: No ]
  • Evaluate, through clinical examinations, the effectiveness of the drug association in reducing excoriation associated with allergic dermatitis. [ Time Frame: 14 days ] [ Designated as safety issue: No ]
  • Evaluate, through clinical examinations, the effectiveness of the drug association in reducing exudation associated with allergic dermatitis. [ Time Frame: 14 dyas ] [ Designated as safety issue: No ]
  • Evaluate, through clinical examinations, the effectiveness of the drug association in reducing of scabbing associated with allergic dermatitis. [ Time Frame: 14 days ] [ Designated as safety issue: No ]
  • Evaluate, through clinical examinations, the effectiveness of the drug association in reducing of lichenification associated with allergic dermatitis. [ Time Frame: 14 days ] [ Designated as safety issue: No ]
  • Evaluate the safety of the formulations in relation to the occurrence, type, frequency and intensity of adverse events during treatment. [ Time Frame: 14 days ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 104
Study Start Date: November 2010
Estimated Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: dexamethasone 0.5 mg and 1.0 mg clemastine cream Drug: dexamethasone 0.5 mg and 1.0 mg clemastine cream
The treatment should be administered every 12 hours so that a thin layer is applied on the lesions, for 14 days.
Active Comparator: dexamethasone 0,5 mg cream Drug: Dexamethasone 0,5 mg cream
The treatment should be administered every 12 hours so that a thin layer is applied on the lesions, for 14 days.

  Eligibility

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

Inclusion Criteria:

  • 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
  • urticaria,
  • pharmacodermic,
  • allergic vasculitis,
  • dyshidrosis,

Exclusion Criteria:

  • 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;
  • 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.
  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 ClinicalTrials.gov identifier: NCT01125761

Locations
Brazil
LAL Clinica Pesquisa e Desenvolvimento Ltda
Valinhos, São Paulo, Brazil, 13276-245
LAL Clínica Pesquisa e Desenvolvimento Ltda
Valinhos, São Paulo, Brazil, 13276-245
Sponsors and Collaborators
L.A.L Clinica Pesquisa e Desenvolvimento Ltda.
  More Information

No publications provided

Responsible Party: Dr. Alexandre Frederico, L.A.L Clinica Pesquisa e Desenvolvimento Ltda.
ClinicalTrials.gov Identifier: NCT01125761     History of Changes
Other Study ID Numbers: DECEMS21209
Study First Received: May 17, 2010
Last Updated: October 25, 2010
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
Dermatitis, Atopic
Skin Diseases
Skin Diseases, Genetic
Genetic Diseases, Inborn
Skin Diseases, Eczematous
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Dexamethasone acetate
Dexamethasone
Dexamethasone 21-phosphate
BB 1101
Clemastine
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Central Nervous System Agents
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Protease Inhibitors
Enzyme Inhibitors

ClinicalTrials.gov processed this record on October 19, 2014