Skip to main content
OpenTrials
Completed

NCT Number: NCT03039634

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Acne Vulgaris Acneiform Eruptions Sebaceous Gland Diseases Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Scottsdale, Arizona, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Change in Total lesion count by blinded investigator

    Time frame: 18 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 2 of this study (ie, 18 weeks post-final treatment).

  2. Change in Total lesion count by blinded investigator

    Time frame: 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).

  3. Safety as assessed by number of adverse events

    Time frame: up to 24 weeks post final treatment

    Adverse events will be monitored throughout the study

Sponsors and collaborators

Lead sponsor

Sienna Labs

Industry

Registry information

Official study 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

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Feb 1, 2017
Registry last updated
Mar 4, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.