Official Title: “Double-Blind Evaluation of the Safety and Efficacy of Quadriderme® (Betamethasone Diproprionate, Clotrimazole and Gentamicin) Compared With Betamethasone Diproprionate Combined With Gentamicin Sulfate and With Betamethasone Diproprionate in the Treatment of Impetiginous Eczema”

This is a parallel-group, randomized, active-controlled, double-blind, Phase 4 trial comparing three creams in the treatment of impetiginous eczema: - Arm A: QUADRIDERME® cream (betamethasone diproprionate, clotrimazole and gentamicin sulfate) - Arm B: Combination of betamethasone diproprionate cream and gentamicin sulfate cream - Arm C: Betamethasone diproprionate cream

At 7 sites, in Portugal, a total of 207 subjects will be randomized using a 1:1:1 randomization ratio to receive one of the three possible treatments for a maximum period of 28 days or until 5 days after total remission of the signs and symptoms, but never more than 28 days. Assessments will be made of level of improvement of the target area in each treatment group, number of days for total remission, and safety profile.

Study Type: Interventional

Study Design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Safety/Efficacy Study

Study Primary Completion Date: November 2009

Intervention(s) in this Clinical Trial

• Drug: Cream (betamethasone diproprionate, clotrimazole, and gentamicin sulfate)
  • Cream [betamethasone 0.05% (in the form of diproprionate), clotrimazole 1%, and gentamicin 0.1% (in the form of sulfate)] applied in a thin layer that covers the affected and surrounding area 2 times a day, morning and night for a maximum period of 28 days or until 5 days after total remission of the signs and symptoms, but never more than 28 days.
• Drug: Cream (betamethasone diproprionate and gentamicin)
  • Cream [betamethasone 0.05% (in the form of diproprionate) and gentamicin 0.1% (in the form of sulfate)] applied in a thin layer that covers the affected and surrounding area 2 times a day, morning and night for a maximum period of 28 days or until 5 days after total remission of the signs and symptoms, but never more than 28 days.
• Drug: Cream (betamethasone diproprionate)
  • Cream [betamethasone 0.05% (in the form of diproprionate)] applied in a thin layer that covers the affected and surrounding area 2 times a day, morning and night for a maximum period of 28 days or until 5 days after total remission of the signs and symptoms, but never more than 28 days.

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: Arm A
  • QUADRIDERME® cream (betamethasone diproprionate, clotrimazole, and gentamicin sulfate)
• Active Comparator: Arm B
  • Combination of betamethasone diproprionate cream and gentamicin sulfate cream
• Active Comparator: Arm C
  • Betamethasone diproprionate cream

Primary Measures

• Percent improvement of individually measured signs of the disease (in a given target area) assessed objectively by the investigator according to predefined scales: 0 to 5 for Erythema, Vesiculation, Scaling, and Pruritis; 1 to 6 for Overall Assessment.
  • Time Frame: Days 1, 8, 15, 21, and 28.
    Safety Issue?: No

Secondary Measures

• The speed of action, measured as the number of days required to achieve total remission.
  • Time Frame: Up to 28 days of treatment.
    Safety Issue?: No
• Safety profile (adverse events, clinical laboratory tests, physical examination, and vital signs)
  • Time Frame: For adverse events, up to 30 days after last dose of study medication; for clinical laboratory tests, Days 1 and 28; for physical examination and vital signs, Days 1, 8, 15, 21, and 28.
    Safety Issue?: Yes

Inclusion Criteria:

• Minimum age: 12 years
• 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 - hemogram with leukogram and platelet count, creatinine, glucose, sed. rate, IgE level and transaminases; along with plasma cortisol and ACTH levels prior to the start of the treatment. These results must all be within normal limits or not clinically relevant in order to be included in the trial.

Exclusion Criteria:

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 12 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Schering-Plough

Information obtained from ClinicalTrials.gov on August 29, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00671528

Study ID Number: P05134

ClinicalTrials.gov Identifier: NCT00671528

Health Authority: Portugal: National Pharmacy and Medicines Institute