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

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.

Study Overview

• Status: Completed
• Conditions: Impetigo
• Intervention / Treatment: Drug: Topical Minocycline Foam FXFM244

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.

• Study Type: Interventional
• Enrollment (Actual): 32
• Phase: Phase 2

Contacts and Locations

Study Locations

• Israel
  • Natanya, Israel
    • Lev Yasmin Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Topical Minocycline Foam FXFM244 - 4%; Minocycline Foam FXFM244 - 4%	Drug: Topical Minocycline Foam FXFM244; FXFM244 - 1%, FXFM244 - 4% to be applied twice daily during 7 days
Experimental: Topical Minocycline Foam FXFM244 - 1%; Minocycline Foam FXFM244 - 1%	Drug: Topical Minocycline Foam FXFM244; FXFM244 - 1%, FXFM244 - 4% to be applied twice daily during 7 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Decrease in lesion count	7 days

Secondary Outcome Measures

Outcome Measure	Time Frame
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.	Days 3, 7 and 14

Collaborators and Investigators

• Sponsor: Vyne Therapeutics Inc.

Study record dates

Study Major Dates

• Study Start: August 1, 2010
• Primary Completion (Actual): March 1, 2012
• Study Completion (Actual): April 1, 2012

Study Registration Dates

• First Submitted: July 27, 2010
• First Submitted That Met QC Criteria: July 27, 2010
• First Posted (Estimate): July 28, 2010

Study Record Updates

• Last Update Posted (Estimate): December 10, 2013
• Last Update Submitted That Met QC Criteria: December 9, 2013
• Last Verified: December 1, 2010

More Information

Terms related to this study

• Keywords: phase II; topical; minocycline; foam; impetigo
• Additional Relevant MeSH Terms: Skin Diseases; Infections; Bacterial Infections; Bacterial Infections and Mycoses; Streptococcal Infections; Gram-Positive Bacterial Infections; Skin Diseases, Infectious; Staphylococcal Infections; Skin Diseases, Bacterial; Staphylococcal Skin Infections; Impetigo; Anti-Infective Agents; Anti-Bacterial Agents; Minocycline
• Other Study ID Numbers: 005-10LND /FX2010-01