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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Topical Minocycline Foam FXFM244 - 4% | Experimental | Minocycline Foam FXFM244 - 4% |
|
| Topical Minocycline Foam FXFM244 - 1% | Experimental | Minocycline Foam FXFM244 - 1% |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Topical Minocycline Foam FXFM244 | Drug | FXFM244 - 1%, FXFM244 - 4% to be applied twice daily during 7 days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Decrease in lesion count | 7 days |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Lev Yasmin Clinic | Netanya | Israel |
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| ID | Term |
|---|---|
| D007169 | Impetigo |
| C562573 | cyclopia sequence |
| ID | Term |
|---|---|
| D013207 | Staphylococcal Skin Infections |
| D013203 | Staphylococcal Infections |
| D016908 | Gram-Positive Bacterial Infections |
| D001424 | Bacterial Infections |
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| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
| D013290 | Streptococcal Infections |
| D017192 | Skin Diseases, Bacterial |
| D012874 | Skin Diseases, Infectious |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |