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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01171326
Recruitment Status : Completed
First Posted : July 28, 2010
Last Update Posted : December 10, 2013
Information provided by (Responsible Party):
Foamix Ltd.

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.

Condition or disease Intervention/treatment Phase
Impetigo Drug: Topical Minocycline Foam FXFM244 Phase 2

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  (Clinical Trial)
Actual Enrollment : 32 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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 Start Date : August 2010
Actual Primary Completion Date : March 2012
Actual Study Completion Date : April 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Impetigo

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

Primary Outcome Measures :
  1. Decrease in lesion count [ Time Frame: 7 days ]

Secondary Outcome Measures :
  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 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   2 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   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:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01171326

Lev Yasmin Clinic
Natanya, Israel
Sponsors and Collaborators
Foamix Ltd.

Responsible Party: Foamix Ltd. Identifier: NCT01171326     History of Changes
Other Study ID Numbers: 005-10LND /FX2010-01
First Posted: July 28, 2010    Key Record Dates
Last Update Posted: December 10, 2013
Last Verified: December 2010

Keywords provided by Foamix Ltd.:
phase II

Additional relevant MeSH terms:
Staphylococcal Skin Infections
Staphylococcal Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Streptococcal Infections
Skin Diseases, Bacterial
Skin Diseases, Infectious
Skin Diseases
Anti-Bacterial Agents
Anti-Infective Agents