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

NCT01171326 | Completed Phase 2

• 1 other identifier: 005-10LND /FX2010-01
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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.

Conditions

Impetigo

Keywords

topical; minocycline; foam; phase II; impetigo

Outcome Measures

Primary Outcomes (1)

• Decrease in lesion count

  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.

  Days 3, 7 and 14

Study Arms (2)

Topical Minocycline Foam FXFM244 - 4%

EXPERIMENTAL

Minocycline Foam FXFM244 - 4%

Drug: Topical Minocycline Foam FXFM244

Topical Minocycline Foam FXFM244 - 1%

EXPERIMENTAL

Minocycline Foam FXFM244 - 1%

Drug: Topical Minocycline Foam FXFM244

Interventions

Topical Minocycline Foam FXFM244 DRUG

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

Topical Minocycline Foam FXFM244 - 1%; Topical Minocycline Foam FXFM244 - 4%

Eligibility Criteria

• Age: 2 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Vyne Therapeutics Inc.: lead

Study Sites (1)

Lev Yasmin Clinic

Netanya, Israel

Location

MeSH Terms

Conditions

Impetigo; cyclopia sequence

Condition Hierarchy (Ancestors)

Staphylococcal Skin Infections; Staphylococcal Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Streptococcal Infections; Skin Diseases, Bacterial; Skin Diseases, Infectious; Skin Diseases; Skin and Connective Tissue Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 27, 2010
• First Posted: July 28, 2010
• Study Start: August 1, 2010
• Primary Completion: March 1, 2012
• Study Completion: April 1, 2012
• Last Updated: December 10, 2013

Record last verified: 2010-12

Locations

IL (1)