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

Overview

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 Title of Study: “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

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Triple (Participant, Care Provider, Investigator)
  • Study Primary Completion Date: April 30, 2013

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

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

Arms, Groups and Cohorts

  • Experimental: Group 1
    • Clemastine fumarate 1,0 mg/g + dexamethasone 0,5/g
  • Active Comparator: Group 2
    • Dexchlorpheniramine maleate 10 mg/g

Clinical Trial Outcome Measures

Primary Measures

  • Reduction / improvement of signs and symptoms
    • Time Frame: DAY 22
    • The reduction of signs an symptoms will be evaluated by OSAAD index.

Secondary Measures

  • Adverse Events Evaluation
    • Time Frame: DAY 22
    • Adverse events will be collected and followed in order to evaluate safety and tolerability.

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 5 Years

Maximum Age: 50 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • EMS
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Flavia Addor, MD, Principal Investigator, Medcin Instituto da Pele
    • Felipe Pinho, MD, Study Director, EMS

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