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

NCT ID: NCT01257061

Last Updated: 2020-07-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 310 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-09-06
• Study Completion Date: 2013-08-02

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

Conditions

Eczema

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Group 1

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

Group Type: EXPERIMENTAL

Group 1

Intervention Type: DRUG

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

Group 2

Dexchlorpheniramine maleate 10 mg/g

Group Type: ACTIVE_COMPARATOR

Group 2

Intervention Type: DRUG

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

Interventions

Group 1

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

Intervention Type: DRUG

Group 2

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

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Patients must be able to understand the study procedures agree to participate and give written consent.

2. Patients with acute or sub-acute eczema.

3. Presence of symmetric lesions to compare on side to the other.

Exclusion Criteria

1. Pregnancy or risk of pregnancy.

2. Lactation

3. Use of anti-inflammatory or immunosuppressive drugs (last 30 days prior to the study).

4. Sunlight over exposure in the last 15 days.

5. Any pathology or past medical condition that can interfere with this protocol.

• Minimum Eligible Age: 5 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

EMS

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Flavia Addor, MD

Role: PRINCIPAL_INVESTIGATOR

Medcin Instituto da Pele

Felipe Pinho, MD

Role: STUDY_DIRECTOR

EMS

Locations

Medcin instituto da Pele

Osasco, São Paulo, Brazil

Countries

Brazil

Other Identifiers

DECEMS1010

Identifier Type: -

Identifier Source: org_study_id