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

Eczema Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01257061
• Other study ID #: DECEMS1010
• Status: Completed
• Phase: Phase 3
• Start date: September 6, 2012
• Est. completion date: August 2, 2013

Study information

• Verified date: June 2020
• Source: EMS
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 310
• Est. completion date: August 2, 2013
• Est. primary completion date: April 30, 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 5 Years to 50 Years

Eligibility

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.

Related Conditions & MeSH terms

• Eczema

Intervention

Drug:
• Group 1
Clemastine fumarate 1,0 mg/g + dexamethasone 0,5/g applied 2 times / day at lesion
• Group 2
Dexchlorpheniramine maleate 10 mg/g applied 2 times / day at lesion

Locations

Country	Name	City	State
Brazil	Medcin instituto da Pele	Osasco	São Paulo

Sponsors (1)

Lead Sponsor	Collaborator
EMS

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reduction / improvement of signs and symptoms	The reduction of signs an symptoms will be evaluated by OSAAD index.	DAY 22
Secondary	Adverse Events Evaluation	Adverse events will be collected and followed in order to evaluate safety and tolerability.	DAY 22