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CompletedNCT01171326Updated Dec 10, 2013

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

A Phase 2 interventional study of Topical Minocycline Foam FXFM244 in Impetigo, sponsored by Vyne Therapeutics Inc.. Completed at 1 site in Israel. Open to participants aged 2 Years and older. Per ClinicalTrials.gov, last updated 2013-12-10.

Sponsored by Vyne Therapeutics Inc. · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
32
Allocation
Randomized
Ages
2 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Impetigo

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Keywords

  • topical
  • minocycline
  • foam
  • phase II
  • impetigo
03

In context

Impetigo

26 studies on the registry are indexed under Impetigo; 3 are open to participants now.

This study's enrollment of 32 is below the median of 314 across 22 interventional studies indexed under Impetigo.

Browse Impetigo studies →

Lead sponsor

Vyne Therapeutics Inc. is the lead sponsor of 32 studies on the registry; none are open to participants now.

Of its 22 completed or terminated interventional studies of FDA-regulated products, 13 (59%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
2 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
32 participants (actual)

Study arms

  • Experimental
    Topical Minocycline Foam FXFM244 - 4%

    Minocycline Foam FXFM244 - 4%

    Drug: Topical Minocycline Foam FXFM244

  • Experimental
    Topical Minocycline Foam FXFM244 - 1%

    Minocycline Foam FXFM244 - 1%

    Drug: Topical Minocycline Foam FXFM244

Interventions

  • DrugTopical Minocycline Foam FXFM244

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

06

What researchers measure

Primary outcomes

  1. Decrease in lesion count

    Time frame: 7 days

Secondary outcomes

  1. 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.

    Time frame: Days 3, 7 and 14

07

Study locations

1 site
  • Lev Yasmin Clinic
    Natanya, Israel
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 10, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01171326
Lead sponsor
Vyne Therapeutics Inc.
Responsible party
Sponsor
First posted
Jul 28, 2010
Start date
Aug 2010
Primary completion
Mar 2012
Completion
Apr 2012
Last update
Dec 10, 2013

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2010. You cannot join it, but the record below documents what was studied.

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