Double-Blind evaluation of the safety and efficacy of Quadriderme cream (betamethasone dipropionate, clotrimazole and gentamicin sulphate ) compare with betamethasone dipropionate combined with gentamicin sulphate and with betamethasone dipropionate in the treatment of Impetiginous Eczema.

• Conditions: Impetiginous Eczema; MedDRA version: 9.1Level: LLTClassification code 10051890Term: Eczema impetiginous

• Registration Number: EUCTR2007-004980-23-PT
• Lead Sponsor: Schering-Plough Farma, Lda.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-11-20
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Mininum age 12 years old
Good general health confirmed by clinical history and a physical and skin examination (excluding area of skin with impetiginous eczema)
Diagnosis of impetiginous eczema.
Ability to understand the procedures of the protocol and follow the requirements during the course of the study.
Results of routine laboratory tests.
This results must all be within normal limits or not clinically relevant in order to be included in the trial.
Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Pregnant patients or women of childbearing age who are not using birth control methods considered reliable by the attending physician.
Patients with history of hypersensitivity to any of the components of the medication being studied.
Patients in whom the extent or severity of the legions requires treatment of a different type than what is planned for this trial.
Patients who need anyother type of topical or systemic medications during the trial that might affect the course of the disease.
Patients who have been treated with other topical medication during the 14-day period prior to the start of the trial.
Patients who have received systemic corticosteroids or any other immunosuppressant medication suring the 28-day period prior to the start of the study.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To assess and compare the eficacy (percent improvement) of each treatment with regard to individually measured signs of the disease (in a given target area) and assessed objectively by the investigator according to predefined scales.;Secondary Objective: To assess the speed of action, measured as the number of days required to achieve total remission. <br>Safety evaluations, including microbiological evaluation of impetiginous eczema lesion and cutaneous surrounding area and photographic records of the target area will also be done.;Primary end point(s): Total remission of signs and symptoms after 5-28 days after treatment.<br>The number of days to complete remission in each group will be compared using the One-Way ANOVA or a nonparametric test.<br>Comparison of the safety profiles of the three therapeutic arms will be done using the chi-square test and One-Way ANOVA depending on each situation.