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

NCT ID: NCT01171326

Last Updated: 2013-12-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 32 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-08-31
• Study Completion Date: 2012-04-30

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 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

Keywords

topical; minocycline; foam; phase II; impetigo

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Topical Minocycline Foam FXFM244 - 4%

Minocycline Foam FXFM244 - 4%

Group Type: EXPERIMENTAL

Topical Minocycline Foam FXFM244

Intervention Type: DRUG

FXFM244 - 1%, FXFM244 - 4% to be applied twice daily during 7 days

Topical Minocycline Foam FXFM244 - 1%

Minocycline Foam FXFM244 - 1%

Group Type: EXPERIMENTAL

Topical Minocycline Foam FXFM244

Intervention Type: DRUG

FXFM244 - 1%, FXFM244 - 4% to be applied twice daily during 7 days

Interventions

Topical Minocycline Foam FXFM244

FXFM244 - 1%, FXFM244 - 4% to be applied twice daily during 7 days

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 2 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Vyne Therapeutics Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Lev Yasmin Clinic

Netanya, , Israel

Countries

Israel

Other Identifiers

005-10LND /FX2010-01

Identifier Type: -

Identifier Source: org_study_id