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

NCT ID: NCT03039634

Last Updated: 2019-03-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

76 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-08-31

Study Completion Date

2018-05-31

Brief Summary

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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.

Detailed Description

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Conditions

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Acne Vulgaris

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sienna Labs

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Paul Lizzul, MD

Role: STUDY_DIRECTOR

Sienna Biopharmaceuticals

Locations

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Scottsdale, Arizona, United States

Site Status

Santa Monica, California, United States

Site Status

Coral Gables, Florida, United States

Site Status

Miami, Florida, United States

Site Status

Hunt Valley, Maryland, United States

Site Status

Beverly, Massachusetts, United States

Site Status

St Louis, Missouri, United States

Site Status

Hackensack, New Jersey, United States

Site Status

Charlotte, North Carolina, United States

Site Status

Yardley, Pennsylvania, United States

Site Status

Charleston, South Carolina, United States

Site Status

Houston, Texas, United States

Site Status

Pflugerville, Texas, United States

Site Status

San Antonio, Texas, United States

Site Status

Jordan, Utah, United States

Site Status

Spokane, Washington, United States

Site Status

Countries

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United States

Other Identifiers

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SL-2016-01_FA

Identifier Type: -

Identifier Source: org_study_id

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