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This study has been withdrawn prior to enrollment.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

May 17, 2010
October 25, 2010
November 2010
November 2010   (final data collection date for 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 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01125761 on ClinicalTrials.gov Archive Site
  • 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 ]
  • Improvement in the erythema associated with allergic dermatitis. [ Time Frame: 14 days ] [ Designated as safety issue: No ]
  • Improvement in the edema associated with allergic dermatitis. [ Time Frame: 14 days ] [ Designated as safety issue: No ]
  • Improvement in the extesion 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 ]
Not Provided
Not Provided
 
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
Not Provided

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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Dermatitis
  • 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.
  • 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.
  • Experimental: dexamethasone 0.5 mg and 1.0 mg clemastine cream
    Intervention: Drug: dexamethasone 0.5 mg and 1.0 mg clemastine cream
  • Active Comparator: dexamethasone 0,5 mg cream
    Intervention: Drug: Dexamethasone 0,5 mg cream
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withdrawn
104
Not Provided
November 2010   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Brazil
 
NCT01125761
DECEMS21209
No
Dr. Alexandre Frederico, L.A.L Clinica Pesquisa e Desenvolvimento Ltda.
L.A.L Clinica Pesquisa e Desenvolvimento Ltda.
Not Provided
Not Provided
L.A.L Clinica Pesquisa e Desenvolvimento Ltda.
April 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP