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

Vyne Therapeutics

Status and phase

Completed

Phase 2

Conditions

Impetigo

Treatments

Drug: Topical Minocycline Foam FXFM244

Study type

Interventional

Funder types

Industry

Identifiers

NCT01171326

005-10LND /FX2010-01

Details and patient eligibility

About

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.

Full 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.

Enrollment

32 patients

Sex

All

Ages

2+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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 criteria

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.