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OpenTrials
Completed

NCT Number: NCT01257061

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

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.

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Key information

Conditions

Eczema Congenital, Hereditary, and Neonatal Diseases and Abnormalities Dermatitis Dermatitis, Atopic Genetic Diseases, Inborn Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Skin Diseases Skin Diseases, Eczematous Skin Diseases, Genetic Skin and Connective Tissue Diseases

Age range

5 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Medcin instituto da Pele

Osasco, São Paulo, 060323-000, Brazil

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients must be able to understand the study procedures agree to participate and give written consent.
  • Patients with acute or sub-acute eczema.
  • Presence of symmetric lesions to compare on side to the other.

Exclusion criteria

  • Pregnancy or risk of pregnancy.
  • Lactation
  • Use of anti-inflammatory or immunosuppressive drugs (last 30 days prior to the study).
  • Sunlight over exposure in the last 15 days.
  • Any pathology or past medical condition that can interfere with this protocol.

Treatment and study plan

Group 1

Drug

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

Group 2

Drug

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

Primary outcomes

  1. Reduction / improvement of signs and symptoms

    Time frame: DAY 22

    The reduction of signs an symptoms will be evaluated by OSAAD index.

Secondary outcomes

  1. Adverse Events Evaluation

    Time frame: DAY 22

    Adverse events will be collected and followed in order to evaluate safety and tolerability.

Sponsors and collaborators

Lead sponsor

EMS

Industry

Registry information

Official study 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.

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Dec 9, 2010
Registry last updated
Jul 7, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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