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Effectiveness of Clemastine Fumarate + Dexamethasone Compared to Dexchlorpheniramine Maleate in Eczema Treatment

Primary Purpose

Eczema

Status

Completed

Phase

Phase 3

Locations

Brazil

Study Type

Interventional

Intervention

Group 1

Group 2

About this trial

This is an interventional treatment trial for Eczema focused on measuring Dermatitis, Dermatitis, Atopic

Eligibility Criteria

5 Years - 50 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Patients must be able to understand the study procedures agree to participate and give written consent.
Patients with acute or sub-acute eczema.
Presence of symmetric lesions to compare on side to the other.

Exclusion Criteria:

Pregnancy or risk of pregnancy.
Lactation
Use of anti-inflammatory or immunosuppressive drugs (last 30 days prior to the study).
Sunlight over exposure in the last 15 days.
Any pathology or past medical condition that can interfere with this protocol.

Sites / Locations

Medcin instituto da Pele

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Group 1

Group 2

Arm Description

Clemastine fumarate 1,0 mg/g + dexamethasone 0,5/g

Dexchlorpheniramine maleate 10 mg/g

Outcomes

Primary Outcome Measures

Reduction / improvement of signs and symptoms

The reduction of signs an symptoms will be evaluated by OSAAD index.

Secondary Outcome Measures

Adverse Events Evaluation

Adverse events will be collected and followed in order to evaluate safety and tolerability.

Full Information

NCT ID

NCT01257061

First Posted

November 29, 2010

Last Updated

July 1, 2020

Sponsor

EMS

1. Study Identification

Unique Protocol Identification Number

NCT01257061

Brief Title

Effectiveness of Clemastine Fumarate + Dexamethasone Compared to Dexchlorpheniramine Maleate in Eczema Treatment

Official Title

Unicentric Comparing Effectiveness Superiority of to Clemastine Fumarate 1, 0 mg/g + Dexamethasone 0, 5 mg/g to Dexchlorpheniramine Maleate 10 mg/g in Eczema Treatment.

Study Type

Interventional

2. Study Status

Record Verification Date

June 2020

Overall Recruitment Status

Completed

Study Start Date

September 6, 2012 (Actual)

Primary Completion Date

April 30, 2013 (Actual)

Study Completion Date

August 2, 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

EMS

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

Atopic dermatitis is a recurrent pruritic skin disorder which has a significant morbidity and impaired quality of life due specially pruritus and physical visible skin lesions. The propose of this trial is evaluate the effectiveness of clemastine fumarate 1, 0 mg/g + dexamethasone 0, 5 mg/g compared to dexchlorpheniramine maleate 10 mg/g in eczema treatment.

Detailed Description

Study design: • Double blinded, superiority, prospective parallel-group, intend to treat trial. Study design: Experiment duration: 22 days 2 visits (days 1,7,15 and 22) Reducing Eczema Area and severity index evaluation Adverse events evaluation

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Eczema

Keywords

Dermatitis, Dermatitis, Atopic

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigator

Allocation

Randomized

Enrollment

310 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Group 1

Arm Type

Experimental

Arm Description

Clemastine fumarate 1,0 mg/g + dexamethasone 0,5/g

Arm Title

Group 2

Arm Type

Active Comparator

Arm Description

Dexchlorpheniramine maleate 10 mg/g

Intervention Type

Drug

Intervention Name(s)

Group 1

Intervention Description

Clemastine fumarate 1,0 mg/g + dexamethasone 0,5/g applied 2 times / day at lesion

Intervention Type

Drug

Intervention Name(s)

Group 2

Intervention Description

Dexchlorpheniramine maleate 10 mg/g applied 2 times / day at lesion

Primary Outcome Measure Information:

Title

Reduction / improvement of signs and symptoms

Description

The reduction of signs an symptoms will be evaluated by OSAAD index.

Time Frame

DAY 22

Secondary Outcome Measure Information:

Title

Adverse Events Evaluation

Description

Adverse events will be collected and followed in order to evaluate safety and tolerability.

Time Frame

DAY 22

10. Eligibility

Sex

All

Minimum Age & Unit of Time

5 Years

Maximum Age & Unit of Time

50 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Patients must be able to understand the study procedures agree to participate and give written consent. Patients with acute or sub-acute eczema. Presence of symmetric lesions to compare on side to the other. Exclusion Criteria: Pregnancy or risk of pregnancy. Lactation Use of anti-inflammatory or immunosuppressive drugs (last 30 days prior to the study). Sunlight over exposure in the last 15 days. Any pathology or past medical condition that can interfere with this protocol.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Flavia Addor, MD

Organizational Affiliation

Medcin Instituto da Pele

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Felipe Pinho, MD

Organizational Affiliation

EMS

Official's Role

Study Director

Facility Information:

Facility Name

Medcin instituto da Pele

City

Osasco

State/Province

São Paulo

ZIP/Postal Code

060323-000

Country

Brazil

12. IPD Sharing Statement

Learn more about this trial

Effectiveness of Clemastine Fumarate + Dexamethasone Compared to Dexchlorpheniramine Maleate in Eczema Treatment

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