Impetigo Clinical Trial
Official title:
A Randomized, Parallel-group, Double Blind, Clinical Trial, to Assess the Safety and Efficacy of Topically Applied FXFM244 Antibiotic Foam in the Treatment of Impetigo
Impetigo is a common, highly infectious skin disease caused by bacterial infection and
characterized by crusting skin lesions. It is most common in children, particularly children
in unhealthy living conditions. In adults, it may follow other skin disorders. Impetigo is
caused primarily by the bacteria Streptococcus pyogenes and/or Staphylococcus aureus, which
can also be isolated from impetigo lesions.
This is a pilot phase II study to evaluate the tolerability and safety and to monitor the
clinical efficacy of Topical Minocycline Foam FXFM244 in impetigo patients.
A randomized, parallel-group, double (Investigator, patient) blind, comparative dose range
finding clinical trial.
The study will involve two treatment groups. Eligible patients will be randomized to receive
either FXFM244 - 1%, FXFM244 - 4% , in a blinded fashion. Patients will be treated twice
daily for 7 days. Following the screening period and baseline visit, study subjects will
return at days 3, 7 and 14. At each visit, patients will be evaluated via lesion count,
global assessment tolerability and safety.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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