Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This study evaluates the safety, effectiveness, and maintenance of effect of a novel topical silver particle solution (Sienna 755.1100, 810.1100, or 1064.1100) used in conjunction with a laser for the treatment of Acne Vulgaris.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Measure | Description | Time Frame |
|---|---|---|
| Change in Total lesion count by blinded investigator | Maintenance of effect by comparing lesion counts conducted at the exit visit of the predecessor study (ie, 12 weeks post-final treatment) and visit 2 of this study (ie, 18 weeks post-final treatment). | 18 weeks post final treatment |
| Change in Total lesion count by blinded investigator | Maintenance of effect by comparing lesion counts conducted at the exit visit of the predecessor study (ie, 12 weeks post-final treatment) and visit 3 of this study (ie, 24 weeks post-final treatment). | 24 weeks post final treatment |
| Safety as assessed by number of adverse events | Adverse events will be monitored throughout the study | up to 24 weeks post final treatment |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Up to 165 subjects will be considered for entry into the study. Subjects completing a predecessor facial acne study (755.1100_FA, 810.1100_FA, or 1064.1100_FA) who meet all study inclusion/exclusion criteria will be offered study participation. There will be no treatments administered in this study.
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Paul Lizzul, MD | Sienna Biopharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Scottsdale | Arizona | 85255 | United States | |||
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Santa Monica |
| California |
| 90404 |
| United States |
| Coral Gables | Florida | 33146 | United States |
| Miami | Florida | 33173 | United States |
| Hunt Valley | Maryland | 21030 | United States |
| Beverly | Massachusetts | 01915 | United States |
| St Louis | Missouri | 92691 | United States |
| Hackensack | New Jersey | 07601 | United States |
| Charlotte | North Carolina | 28207 | United States |
| Yardley | Pennsylvania | 19067 | United States |
| Charleston | South Carolina | 29414 | United States |
| Houston | Texas | 77030 | United States |
| Pflugerville | Texas | 78660 | United States |
| San Antonio | Texas | 78229 | United States |
| Jordan | Utah | 84088 | United States |
| Spokane | Washington | 99204 | United States |
| ID | Term |
|---|---|
| D000152 | Acne Vulgaris |
| ID | Term |
|---|---|
| D017486 | Acneiform Eruptions |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D012625 | Sebaceous Gland Diseases |
Not provided
Not provided