Long-term Follow-up Study of Subjects Who Completed Clinical Studies 755.1100_FA, 810.1100_FA, or 1064.1100_FA

Sienna Labs

Status: Completed

Conditions: Acne Vulgaris

Study type: Observational

Funder types: Industry

Identifiers

NCT03039634

SL-2016-01_FA

Details and patient eligibility

About

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.

Enrollment: 76 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.