NCT01171326

Study to Evaluate the Safety and Efficacy of Topical Minocycline FXFM244 in Impetigo Patients

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 32 (actual)
• Sponsor: Vyne Therapeutics Inc. · Industry
• Sex: All
• Age: 2 Years
• Healthy volunteers: Not accepted

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 description

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.

Conditions

• Impetigo

Interventions

Type	Name	Description
DRUG	Topical Minocycline Foam FXFM244	FXFM244 - 1%, FXFM244 - 4% to be applied twice daily during 7 days

Timeline

• Start date: 2010-08-01
• Primary completion: 2012-03-01
• Completion: 2012-04-01
• First posted: 2010-07-28
• Last updated: 2013-12-10

Locations

1 site across 1 country: Israel