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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
3
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.
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.
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.
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: 1. Cure- Complete remission 2. \> 75% reduction: Marked improvement 3. 50-75% reduction: Moderate improvement 4. 25-50% reduction: Slight improvement 5. \<25% reduction: Ineffectiveness 6. Worsening of signs \& symptoms
Time frame: Days 1 (prior to start of treatment), 8, 15, 21, and 28.
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.
Time frame: Up to 28 days
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