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

Primary Purpose

Impetigo

Status

Completed

Phase

Phase 2

Locations

Israel

Study Type

Interventional

Intervention

Topical Minocycline Foam FXFM244

About this trial

This is an interventional treatment trial for Impetigo focused on measuring topical, minocycline, foam, phase II, impetigo

Eligibility Criteria

2 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

Lev Yasmin Clinic

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Topical Minocycline Foam FXFM244 - 4%

Topical Minocycline Foam FXFM244 - 1%

Arm Description

Minocycline Foam FXFM244 - 4%

Minocycline Foam FXFM244 - 1%

Outcomes

Primary Outcome Measures

Decrease in lesion count

Secondary Outcome Measures

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.

Full Information

NCT ID

NCT01171326

First Posted

July 27, 2010

Last Updated

December 9, 2013

Sponsor

Vyne Therapeutics Inc.

1. Study Identification

Unique Protocol Identification Number

NCT01171326

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

December 2010

Overall Recruitment Status

Completed

Study Start Date

August 2010 (undefined)

Primary Completion Date

March 2012 (Actual)

Study Completion Date

April 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Vyne Therapeutics Inc.

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Impetigo

Keywords

topical, minocycline, foam, phase II, impetigo

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

32 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Topical Minocycline Foam FXFM244 - 4%

Arm Type

Experimental

Arm Description

Minocycline Foam FXFM244 - 4%

Arm Title

Topical Minocycline Foam FXFM244 - 1%

Arm Type

Experimental

Arm Description

Minocycline Foam FXFM244 - 1%

Intervention Type

Drug

Intervention Name(s)

Topical Minocycline Foam FXFM244

Intervention Description

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

Primary Outcome Measure Information:

Title

Decrease in lesion count

Time Frame

7 days

Secondary Outcome Measure Information:

Title

Time Frame

Days 3, 7 and 14

10. Eligibility

Sex

All

Minimum Age & Unit of Time

2 Years

Accepts Healthy Volunteers

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.

Facility Information:

Facility Name

Lev Yasmin Clinic

City

Natanya

Country

Israel

12. IPD Sharing Statement

Learn more about this trial

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

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