Clinical trial NCT03039634: Long-term Follow-up Study of Subjects Who Completed Clinical Studies 755.1100_FA, 810.1100_FA, or 1064.1100_FA
Official title: A Multicenter, Double-blind, Nontreatment, Long-term, Follow-up Study of Subjects Who Completed Clinical Studies 755.1100_FA, 810.1100_FA, or 1064.1100_FA of a Topical Silver Particle Solution Followed by Laser for the Treatment of Facial Acne Vulgaris
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acne Vulgaris
Lead sponsor: Sienna Labs
Sponsor class: INDUSTRY
First posted: 2017-02-01
Enrollment: 76
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Change in Total lesion count by blinded investigator
timeFrame: 18 weeks post final treatment
measure: Change in Total lesion count by blinded investigator
timeFrame: 24 weeks post final treatment
measure: Safety as assessed by number of adverse events
timeFrame: up to 24 weeks post final treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Scottsdale
country: United States
state: Arizona
city: Santa Monica
country: United States
state: California
city: Coral Gables
country: United States
state: Florida
city: Miami
country: United States
state: Florida
city: Hunt Valley
country: United States
state: Maryland
city: Beverly
country: United States
state: Massachusetts
city: Saint Louis
country: United States
state: Missouri
city: Hackensack
country: United States
state: New Jersey
city: Charlotte
country: United States
state: North Carolina
city: Yardley
country: United States
state: Pennsylvania
city: Charleston
country: United States
state: South Carolina
city: Houston
country: United States
state: Texas
city: Pflugerville
country: United States
state: Texas
city: San Antonio
country: United States
state: Texas
city: Jordan
country: United States
state: Utah
city: Spokane
country: United States
state: Washington
Study officials:
affiliation: Sienna Biopharmaceuticals
name: Paul Lizzul, MD
role: STUDY_DIRECTOR
References: