Long-term Follow-up Study of Subjects Who Completed Clinical Studies 755.1100_FA, 810.1100_FA, or 1064.1100_FA
Completed
- Conditions
- Acne Vulgaris
- Registration Number
- NCT03039634
- Lead Sponsor
- Sienna Labs
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 76
Inclusion Criteria
- Subject has participated in study 755.1100_FA, 810.1100_FA, or 1064.1100_FA and fulfilled that study's exit criteria (ie, completion of the final visit [visit 7] of that study).
- Subject has followed predecessor study restrictions prior to study entry.
- Subject is able to provide informed consent and Health Insurance Portability and Accountability Act (HIPAA); minors will in addition have parent or legal guardian provide consent.
- Subject is willing to comply with the schedule, procedures, and restrictions of the study.
Exclusion Criteria
- Subjects who have had any treatments or conditions (eg, pregnancy or metabolic disease) that may affect assessment of the safety or efficacy since enrollment in the predecessor study.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Change in Total lesion count by blinded investigator 24 weeks post final treatment 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).
Safety as assessed by number of adverse events up to 24 weeks post final treatment Adverse events will be monitored throughout the study
- Secondary Outcome Measures
Name Time Method