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

2014-08-27 03:30:53 | BioPortfolio

Summary

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 Design

Allocation: Randomized, Control: Active Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Conditions

Dermatitis, Atopic

Intervention

Cream (betamethasone diproprionate, clotrimazole, and gentamicin sulfate), Cream (betamethasone diproprionate and gentamicin), Cream (betamethasone diproprionate)

Location

Investigational Site 2
Leiria
Portugal
2410-197

Status

Recruiting

Source

Schering-Plough

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:30:53-0400

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