Status:
COMPLETED
Study to Evaluate the Safety and Efficacy of Topical Minocycline FXFM244 in Impetigo Patients
Lead Sponsor:
Vyne Therapeutics Inc.
Conditions:
Impetigo
Eligibility:
All Genders
2+ years
Phase:
PHASE2
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 ...
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...
Eligibility Criteria
Inclusion
- Patients with clinical diagnosis of pure impetigo, impetigo contagiosa, or uncomplicated blistering impetigo
- Patients 2 years of age or older, and in general good health
- Patients with no less than two lesions and no more than seven lesions, area 0.5x0.5cm.
- No known medical conditions that, in the Investigator's opinion could interfere with study participation
- Patient / Patient's guardian (in the case of children) willing and able to comply with all requirement of the protocol
- Patient / Patient's guardian willing and able to give written informed consent prior to participation in the study
Exclusion
- Presence of skin diseases at or near the investigational area
- Immunosuppressed state or other serious systemic disease
- Signs and/or symptoms of systemic infection
- Presence of skin infection/disorder not amenable to topical antibacterial treatment only
- Presence of secondarily-infected animal/human bite
- Presence of secondarily infected burn wound
- Topical or systemic use of medicinal or other products before or during the study (oral or topical antibiotics, oral or topical corticosteroids and immuno modulators); or other drugs, which in the Investigators opinion could confound the evaluation of the effect of the study drugs
- Known or suspected hypersensitivity to Minocycline or any of the excipients in the study medication
- Participation in any other investigational drug study or use of (an) investigational drug(s) within the 30 days or 5 half-lives (whichever is longer) prior to randomization
- Patients previously enrolled/randomized in this study
- Use of another investigational drug within 30 days prior to entry into this study.
- Pregnant or lactating women.
Key Trial Info
Start Date :
August 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2012
Estimated Enrollment :
32 Patients enrolled
Trial Details
Trial ID
NCT01171326
Start Date
August 1 2010
End Date
April 1 2012
Last Update
December 10 2013
Active Locations (1)
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1
Lev Yasmin Clinic
Netanya, Israel