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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

Sponsor
Sienna Labs (Industry)
Overall Status
Completed
CT.gov ID
NCT03039634
Collaborator
(none)
76
Enrollment
16
Locations
21
Duration (Months)
4.8
Patients Per Site
0.2
Patients Per Site Per Month

Study Details

Study Description

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 Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    76 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 :
    Aug 1, 2016
    Actual Primary Completion Date :
    May 1, 2018
    Actual Study Completion Date :
    May 1, 2018

    Outcome Measures

    Primary Outcome Measures

    1. Change in Total lesion count by blinded investigator [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 [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 [up to 24 weeks post final treatment]

      Adverse events will be monitored throughout the study

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Scottsdale Arizona United States 85255
    2 Santa Monica California United States 90404
    3 Coral Gables Florida United States 33146
    4 Miami Florida United States 33173
    5 Hunt Valley Maryland United States 21030
    6 Beverly Massachusetts United States 01915
    7 Saint Louis Missouri United States 92691
    8 Hackensack New Jersey United States 07601
    9 Charlotte North Carolina United States 28207
    10 Yardley Pennsylvania United States 19067
    11 Charleston South Carolina United States 29414
    12 Houston Texas United States 77030
    13 Pflugerville Texas United States 78660
    14 San Antonio Texas United States 78229
    15 Jordan Utah United States 84088
    16 Spokane Washington United States 99204

    Sponsors and Collaborators

    • Sienna Labs

    Investigators

    • Study Director: Paul Lizzul, MD, Sienna Biopharmaceuticals

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Sienna Labs
    ClinicalTrials.gov Identifier:
    NCT03039634
    Other Study ID Numbers:
    • SL-2016-01_FA
    First Posted:
    Feb 1, 2017
    Last Update Posted:
    Mar 4, 2019
    Last Verified:
    May 1, 2018
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Additional relevant MeSH terms:
    Acne Vulgaris

    Study Results

    No Results Posted as of Mar 4, 2019