Clinical Trial: Study to Evaluate the Safety and Efficacy of Topical Minocycline FXFM244 in Impetigo Patients
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
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
Brief Summary:
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.
Detailed Summary:
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.
Sponsor: Foamix Ltd.
Current Primary Outcome: Decrease in lesion count [ Time Frame: 7 days ]
Original Primary Outcome: Same as current
Current Secondary Outcome: The severity of the overall impetigo condition will be measured at baseline and at all follow-up visits. The severity will be assessed and graded based on the scales for Investigator's Global Assessment and bacteriological testing. [ Time Frame: Days 3, 7 and 14 ]
Original Secondary Outcome: Same as current
Information By: Foamix Ltd.
Dates:
Date Received: July 27, 2010
Date Started: August 2010
Date Completion:
Last Updated: December 9, 2013
Last Verified: December 2010
