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The purpose of this study is to assess the pharmakokinetic profile of Minocycline in FMX-101 4% foam product in male and female some of which are with acne
This is an open-label, single-center, non-randomized, multiple-administrations study in males and females, some of which are with acne.
Twelve (12) subjects will be enrolled to receive a daily dose of topical FMX-101 minocycline (4%) foam for sixteen consecutive days.
Each subject will undergo screening procedures within 21 days prior to dosing, to assess his eligibility to participate in the study, including a dermatological assessment of the acne severity and distribution (for subjects with acne).
On Days 1, 2, 3, 7, 9, 11, 14, 16 and 17 blood will be drawn for PK An End-of Study/Safety Follow-up visit will take place on 7-10 days after last dose, which will also include a dermatological assessment of response to treatment
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| FMX101 Minocycline 4% foam | Experimental | FMX101, 4% applied to the face, upper chest, upper back and shoulders for sixsteen consecutive days in subjects either with acne or with normal skin |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| FMX101, Minocycline 4% foam | Drug | FMX101, Minocycline 4% foam to be applied twice daily for 16 consecutive days |
|
| Measure | Description | Time Frame |
|---|---|---|
| adverse events | AEs will be assessed starting from informed consent signature until end of study) | 22-25 days |
| irritation and local reaction | The application area will be examined for irritation and local reaction | 16 days |
| Change from baseline in vital signs | sitting BP, HR, RR, oral temperature | 22-25 days |
| Cmax | will be assessed after 1 and 16 days of dosing | 16 days |
| Tmax | will be assessed after 1 and 16 days of dosing | 16 days |
| AUCT | will be assessed after 1 and 16 days of dosing | 16 days |
| T½ | will be assessed after 1 and 16 days of dosing | 16 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jacob Atsmon, MD | Sourasky Medical center, Tel-aviv, Israel | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sourasky Medical Center, Clinical Research Center | Tel Aviv | Israel |
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| ID | Term |
|---|---|
| D000152 | Acne Vulgaris |
| ID | Term |
|---|---|
| D017486 | Acneiform Eruptions |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D012625 | Sebaceous Gland Diseases |
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| ID | Term |
|---|---|
| D008911 | Minocycline |
| ID | Term |
|---|---|
| D013754 | Tetracyclines |
| D009279 | Naphthacenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
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| D006844 |
| Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011083 | Polycyclic Compounds |