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

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ClinicalTrials.gov Identifier: NCT03039634
Recruitment Status : Recruiting
First Posted : February 1, 2017
Last Update Posted : May 23, 2018
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease
Acne Vulgaris

Study Type : Observational
Estimated Enrollment : 165 participants
Observational Model: Cohort
Time Perspective: Prospective
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 Start Date : August 2016
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Acne




Primary Outcome Measures :
  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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03039634


Contacts
Contact: Nicole Miller 443-308-5825 emacy@cssienroll.com

Locations
United States, Arizona
Recruiting
Scottsdale, Arizona, United States, 85255
United States, California
Recruiting
Santa Monica, California, United States, 90404
United States, Florida
Recruiting
Coral Gables, Florida, United States, 33146
Recruiting
Miami, Florida, United States, 33173
United States, Maryland
Recruiting
Hunt Valley, Maryland, United States, 21030
United States, Massachusetts
Recruiting
Beverly, Massachusetts, United States, 01915
United States, Missouri
Recruiting
Saint Louis, Missouri, United States, 92691
United States, New Jersey
Recruiting
Hackensack, New Jersey, United States, 07601
United States, North Carolina
Recruiting
Charlotte, North Carolina, United States, 28207
United States, Pennsylvania
Recruiting
Yardley, Pennsylvania, United States, 19067
United States, South Carolina
Recruiting
Charleston, South Carolina, United States, 29414
United States, Texas
Recruiting
Houston, Texas, United States, 77030
Recruiting
Pflugerville, Texas, United States, 78660
Recruiting
San Antonio, Texas, United States, 78229
United States, Utah
Recruiting
Jordan, Utah, United States, 84088
United States, Washington
Recruiting
Spokane, Washington, United States, 99204
Sponsors and Collaborators
Sienna Labs
Investigators
Study Director: Paul Lizzul, MD Sienna Biopharmaceuticals

Responsible Party: Sienna Labs
ClinicalTrials.gov Identifier: NCT03039634     History of Changes
Other Study ID Numbers: SL-2016-01_FA
First Posted: February 1, 2017    Key Record Dates
Last Update Posted: May 23, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Acne Vulgaris
Acneiform Eruptions
Skin Diseases
Sebaceous Gland Diseases