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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Foamix Ltd.
ClinicalTrials.gov Identifier:
NCT01171326
First received: July 27, 2010
Last updated: April 25, 2012
Last verified: December 2010
History of Changes
  Purpose

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 Intervention Phase
Impetigo
 Drug: Topical Minocycline Foam FXFM244
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Foamix Ltd.:

Primary Outcome Measures:
  • Decrease in lesion count [ Time Frame: 7 days ] [ Designated as safety issue: Yes ]

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. [ Time Frame: Days 3, 7 and 14 ] [ Designated as safety issue: Yes ]

Enrollment: 32
Study Start Date: August 2010
Study Completion Date: April 2012
Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Topical 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% Drug: Topical Minocycline Foam FXFM244
FXFM244 - 1%, FXFM244 - 4% to be applied twice daily during 7 days

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.

  Eligibility

Ages Eligible for Study:   2 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01171326

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

No publications provided

Responsible Party: Foamix Ltd.
ClinicalTrials.gov Identifier: NCT01171326     History of Changes
Other Study ID Numbers: 005-10LND /FX2010-01
Study First Received: July 27, 2010
Last Updated: April 25, 2012
Health Authority: Israel: Institutional Review Board - Laniado Hospital

Keywords provided by Foamix Ltd.:
topical
minocycline
foam
phase II
impetigo

Additional relevant MeSH terms:
Impetigo
Staphylococcal Skin Infections
Staphylococcal Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Streptococcal Infections
Skin Diseases, Bacterial
Skin Diseases, Infectious
 Infection
Skin Diseases
Minocycline
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on October 17, 2012