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

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

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.

Study Overview

• Status: Completed
• Conditions: Acne Vulgaris

• Study Type: Observational
• Enrollment (Actual): 76

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Scottsdale, Arizona, United States, 85255
  • California
    • Santa Monica, California, United States, 90404
  • Florida
    • Coral Gables, Florida, United States, 33146
    • Miami, Florida, United States, 33173
  • Maryland
    • Hunt Valley, Maryland, United States, 21030
  • Massachusetts
    • Beverly, Massachusetts, United States, 01915
  • Missouri
    • Saint Louis, Missouri, United States, 92691
  • New Jersey
    • Hackensack, New Jersey, United States, 07601
  • North Carolina
    • Charlotte, North Carolina, United States, 28207
  • Pennsylvania
    • Yardley, Pennsylvania, United States, 19067
  • South Carolina
    • Charleston, South Carolina, United States, 29414
  • Texas
    • Houston, Texas, United States, 77030
    • Pflugerville, Texas, United States, 78660
    • San Antonio, Texas, United States, 78229
  • Utah
    • Jordan, Utah, United States, 84088
  • Washington
    • Spokane, Washington, United States, 99204

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Sienna Labs
• Investigators: Study Director: Paul Lizzul, MD, Sienna Biopharmaceuticals

Study record dates

Study Major Dates

• Study Start: August 1, 2016
• Primary Completion (Actual): May 1, 2018
• Study Completion (Actual): May 1, 2018

Study Registration Dates

• First Submitted: January 25, 2017
• First Submitted That Met QC Criteria: January 30, 2017
• First Posted (Estimate): February 1, 2017

Study Record Updates

• Last Update Posted (Actual): March 4, 2019
• Last Update Submitted That Met QC Criteria: February 28, 2019
• Last Verified: May 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Acneiform Eruptions; Sebaceous Gland Diseases; Acne Vulgaris
• Other Study ID Numbers: SL-2016-01_FA

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO