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

EMS

Status and phase: Completed; Phase 3

Conditions: Eczema

Treatments: Drug: Group 1; Drug: Group 2

Study type: Interventional

Funder types: Industry

Identifiers

NCT01257061

DECEMS1010

Details and patient eligibility

About

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.

Full 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

Enrollment: 310 patients

Sex: All

Ages: 5 to 50 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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310 participants in 2 patient groups

Group 1

Experimental group

Description:

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

Treatment:

Drug: Group 1

Group 2

Active Comparator group

Description:

Dexchlorpheniramine maleate 10 mg/g

Treatment:

Drug: Group 2