Impetigo Clinical Trial
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
Verified date | December 2010 |
Source | Foamix Ltd. |
Contact | n/a |
Is FDA regulated | No |
Health authority | Israel: Institutional Review Board - Laniado Hospital |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 32 |
Est. completion date | April 2012 |
Est. primary completion date | March 2012 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 2 Years and older |
Eligibility |
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. |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Israel | Lev Yasmin Clinic | Natanya |
Lead Sponsor | Collaborator |
---|---|
Foamix Ltd. |
Israel,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Decrease in lesion count | 7 days | Yes | |
Secondary | 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 | Yes |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT00884728 -
Evaluation of a Regional Healthy Skin Program in Remote Aboriginal Communities of Australia's Northern Territory
|
N/A | |
Completed |
NCT02902822 -
Tele-dermatology of Skin Cancer in a Cohort of Local Health Authority Employees in the Province of Bergamo
|
N/A | |
Completed |
NCT01153828 -
EU PV for Retapamulin-Prescribing
|
N/A | |
Active, not recruiting |
NCT05226260 -
Decreasing Antibiotic Duration for Skin and Soft Tissue Infection Using Behavioral Economics in Primary Care
|
N/A | |
Terminated |
NCT00986856 -
Fucidin® Cream in the Treatment of Impetigo
|
Phase 4 | |
Completed |
NCT01397461 -
Efficacy and Safety of Ozenoxacin 1% Cream Versus Placebo in the Treatment of Patients With Impetigo
|
Phase 3 | |
Recruiting |
NCT02090764 -
Efficacy and Safety of Ozenoxacin 1% Cream Versus Placebo in the Treatment of Patients With Impetigo
|
Phase 3 | |
Completed |
NCT02775617 -
Azithromycin - Ivermectin Mass Drug Administration for Skin Disease
|
Phase 4 | |
Not yet recruiting |
NCT01611909 -
Citriodiol® and Impetigo
|
Phase 2/Phase 3 | |
Completed |
NCT03177993 -
Fiji Integrated Therapy (FIT) - Triple Therapy for Lymphatic Filariasis, Scabies and Soil Transmitted Helminths in Fiji
|
N/A | |
Completed |
NCT03429595 -
Study Evaluating the Safety, Tolerability, PK, and Activity of Topical ATx201 Gel in Outpatients With Impetigo
|
Phase 2 | |
Completed |
NCT04287777 -
Safety and Efficacy of Mupirocin Gel in Children With Impetigo
|
Phase 3 | |
Completed |
NCT00626795 -
Efficacy, Safety, and Tolerability of TD1414 2% Cream in Impetigo and Secondarily Infected Traumatic Lesions (SITL)
|
Phase 2 | |
Completed |
NCT00758862 -
The Pharmacokinetics of 2% TD1414 Cream in Adults With Secondarily Infected Traumatic Lesions (SITL) or Impetigo
|
Phase 2 | |
Recruiting |
NCT01943136 -
The Efficacy and Safety of Topical Papaya (Carica Papaya) Leaf Extract 1% Ointment Versus Mupirocin 2% Ointment in the Treatment of Limited Impetigo: a Randomized, Double-blind, Controlled Clinical Trial
|
Phase 1 | |
Completed |
NCT01670032 -
Vehicle Controlled Efficacy and Safety Study of Two Dose Regimens of CD07223 1.5% Topical Gel in Impetigo
|
Phase 2/Phase 3 | |
Completed |
NCT01367314 -
Safety and Efficacy of Topical NVC-422 Gel in Impetigo
|
Phase 2 | |
Completed |
NCT01126268 -
Twice Daily Altabax Application for the Treatment of Uncomplicated Soft Tissue Infection
|
Phase 4 | |
Completed |
NCT00852540 -
Retapamulin Versus Linezolid in the Treatment of SITL and Impetigo Due to MRSA
|
Phase 3 | |
Completed |
NCT00133848 -
Treatment Of Impetigo With Topical SB-275833 Ointment, 1% Versus Topical Placebo Ointment
|
Phase 3 |