Efficacy and Safety of the Association Drugs in Patients With Allergic Dermatitis

November 1, 2022 updated by: Azidus Brasil

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • São Paulo
      • Valinhos, São Paulo, Brazil, 13276-245
        • LAL Clínica Pesquisa e Desenvolvimento Ltda

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

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

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 Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
14 days

Secondary Outcome Measures

Outcome Measure
Time Frame
Improvement of the erythema associated with allergic dermatitis.
Time Frame: 14 days
14 days
Improvement of the edema associated with allergic dermatitis.
Time Frame: 14 days
14 days
Improvement of the extension of lesion associated with allergic dermatitis.
Time Frame: 14 days
14 days
Evaluate, through clinical examinations, the effectiveness of the drug association in reducing excoriation associated with allergic dermatitis.
Time Frame: 14 days
14 days
Evaluate, through clinical examinations, the effectiveness of the drug association in reducing exudation associated with allergic dermatitis.
Time Frame: 14 dyas
14 dyas
Evaluate, through clinical examinations, the effectiveness of the drug association in reducing of scabbing associated with allergic dermatitis.
Time Frame: 14 days
14 days
Evaluate, through clinical examinations, the effectiveness of the drug association in reducing of lichenification associated with allergic dermatitis.
Time Frame: 14 days
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
14 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Azidus Brasil

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

November 1, 2010

Primary Completion (Anticipated)

November 1, 2010

Study Completion

November 1, 2010

Study Registration Dates

First Submitted

May 17, 2010

First Submitted That Met QC Criteria

May 17, 2010

First Posted (Estimate)

May 18, 2010

Study Record Updates

Last Update Posted (Actual)

November 3, 2022

Last Update Submitted That Met QC Criteria

November 1, 2022

Last Verified

November 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DECEMS21209

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.

Clinical Trials on Dermatitis

Clinical Trials on dexamethasone 0.5 mg and 1.0 mg clemastine cream

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Djibouti

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe