Safety and Efficacy of Quadriderme® in the Treatment of Impetiginous Eczema (Study P05134AM4)
Merck Sharp & Dohme Corp.
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
- 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
Safety and Efficacy of Gentamicin Topical Gel (AppliGel-G) for Treatment of Mild to Moderately Infected Diabetic Foot Ulcers
Royer Biomedical, Inc.
Phase 1/Phase 2
The purpose of this study is to determine whether AppliGel-G (Gentamicin topical gel) plus
oral Ciprofloxacin / Doxycycline are safe and effective in the treatment of mild to
moderately infected foot ulcers in diabetic patients.
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