Safety and Efficacy of Quadriderme® in the Treatment of Impetiginous Eczema (Study P05134AM4)

Study Overview
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Brief Summary
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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. Note: This study was terminated early due to lack of recruitment (only 3 of the 207 planned participants were enrolled). Statistical analyses were not performed. Further, 7 sites were planned, but only 4 sites were approved out of which 3 sites were initiated.

Official Title
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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

Conditions
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Dermatitis, Atopic, Eczema, Atopic, Skin Diseases, Eczematous

Intervention / Treatment
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* Drug: Cream (betamethasone diproprionate, clotrimazole, and gentamicin sulfate)
* Drug: Cream (betamethasone diproprionate and gentamicin)
* Drug: Cream (betamethasone diproprionate)


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

Ages Eligible for Study
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Minimum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: QUADRIDERME® cream<br>QUADRIDERME® cream (betamethasone diproprionate, clotrimazole, and gentamicin sulfate) | Drug: Cream (betamethasone diproprionate, clotrimazole, and gentamicin sulfate)<br>* Betamethasone diproprionate 0.05%, clotrimazole 1%, and gentamicin sulfate 0.1% cream applied in a thin layer that covers the affected and surrounding area 2 times a day (BID), 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.<br>* Other names: QUADRIDERME® cream, SCH 000411;|
| Active Comparator: Betamethasone and Gentamicin<br>Combination of betamethasone diproprionate cream and gentamicin sulfate cream | Drug: Cream (betamethasone diproprionate and gentamicin)<br>* Betamethasone diproprionate 0.05% and gentamicin sulfate 0.1% cream applied in a thin layer that covers the affected and surrounding area BID, 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.<br>|
| Active Comparator: Betamethasone<br>Betamethasone diproprionate cream | Drug: Cream (betamethasone diproprionate)<br>* Betamethasone diproprionate 0.05% cream applied in a thin layer that covers the affected and surrounding area BID, 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent Improvement of Individually Measured Signs of the Disease | Percent improvement of individually measured signs of the disease (erythema, vesiculation, scaling, pruritis) in a given target area that was chosen by the investigator was assessed objectively & quantified on a scale of 0-5 (0-absent, 5-very intense). Overall assessment reflected the changes in the disease & was carried out by the investigator. The following scale was used: Cure- Complete remission > 75% reduction: Marked improvement 50-75% reduction: Moderate improvement 25-50% reduction: Slight improvement <25% reduction: Ineffectiveness Worsening of signs & symptoms | Days 1 (prior to start of treatment), 8, 15, 21, and 28. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Days Required to Achieve Total Remission | The speed of action, measured as the number of days required to achieve total remission of all signs and symptoms of the disease. | Up to 28 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Impetiginous