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The purpose of this study is to evaluate the tolerability and safety and to determine whether FXFM244 Antibiotic Foam is effective in the treatment of Acne Vulgaris.
This is a phase IIa prospective, multicenter, randomized, double blind, placebo controlled, parallel group, dose range finding clinical study to evaluate the safety, tolerability and efficacy of Minocycline Foam 1% and 4% for the treatment of Acne Vulgaris.
The study consists of a screening / baseline visit, a treatment period where patients will be treated topically on the facial skin areas affected by acne twice daily for 12 weeks, followed by a post-treatment follow up visit 4 weeks after end of treatment. The first dose will be applied in the presence of the study investigator or his assignee. Subsequent applications will be made by the patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Topical Minocycline Foam FXFM244 - 4% | Experimental | Active ingredient: Minocycline Concentration: 4% Route: Topical Dosage schedule: Once daily, evening. |
|
| Topical Minocycline Foam FXFM244 - 1% | Experimental | Active ingredient: Minocycline Concentration: 1% Route: Topical Dosage schedule: Once daily, evening. |
|
| Placebo foam | Placebo Comparator | Active ingredient: None Route: Topical Dosage schedule: Once daily, evening |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Topical Minocycline Foam FXFM244 | Drug | Topically applied once a day. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Decrease in lesions count | The change in lesion count (inflammatory, non-inflammatory, and total) after 12 weeks of treatment compared to baseline | 12 weeks |
| Investigator global assessment | Physician's Global Improvement Assessment | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| % change in lesions count | The % change in lesions count (inflammatory, non-inflammatory, and total) after 12 weeks of treatment compared to baseline | 12 weeks |
| Global assessment of improvement by photographs |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Joseph Shiri, Prof. | Clalit Health Services | Principal Investigator |
| Eli Sprecher, MD | Sourasky Medical Center | Principal Investigator |
| Avner Shemer, Prof. | Lev Yasmin clinic, Netanya, Israel | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Lev Yasmin clinic | Netanya | Israel | ||||
| Sourasky medical center |
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| ID | Term |
|---|---|
| D000152 | Acne Vulgaris |
| C562573 | cyclopia sequence |
| ID | Term |
|---|---|
| D017486 | Acneiform Eruptions |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D012625 | Sebaceous Gland Diseases |
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The photographs will assist in comparison of efficacy at subsequent visits compared to baseline
| 12 weeks |
| Subject-reported outcome assessment | 12 weeks |
| Subjects safety | safety parameters will be assessed by
| 12 weeks |
| Tel Aviv |
| Israel |
| Tel-Nordau Clalit health services | Tel Aviv | Israel |