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

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.

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01257061

Enrollment

310

Registered

2010-12-09

Start date

2012-09-06

Completion date

2013-08-02

Last updated

2020-07-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Eczema

Keywords

Dermatitis, Dermatitis, Atopic

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

Interventions

DRUGGroup 1

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

DRUGGroup 2

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender

ALL

Age

5 Years to 50 Years

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.

Design outcomes

Primary

Measure	Time frame	Description
Reduction / improvement of signs and symptoms	DAY 22	The reduction of signs an symptoms will be evaluated by OSAAD index.

Secondary

Measure	Time frame	Description
Adverse Events Evaluation	DAY 22	Adverse events will be collected and followed in order to evaluate safety and tolerability.

Countries

Brazil

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026