CClinicalTrials.gg
CompletedNCT03039634Updated Mar 4, 2019

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

An observational study in Acne Vulgaris, sponsored by Sienna Labs. Completed at 16 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-03-04.

Sponsored by Sienna Labs · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
76
Ages
18 Years and older
Sex
All
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Study 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.

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Conditions studied

  • Acne Vulgaris

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03

In context

Acne Vulgaris

730 studies on the registry are indexed under Acne Vulgaris; 86 are open to participants now.

This study's enrollment of 76 is below the median of 90 across 81 observational studies indexed under Acne Vulgaris.

Browse Acne Vulgaris studies →

Lead sponsor

This is the only study on the registry with Sienna Labs as lead sponsor.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
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.

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

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.
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
76 participants (actual)
Patient registry
No
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What researchers measure

Primary outcomes

  1. 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).

    Time frame: 18 weeks post final treatment

  2. 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).

    Time frame: 24 weeks post final treatment

  3. Safety as assessed by number of adverse events

    Adverse events will be monitored throughout the study

    Time frame: up to 24 weeks post final treatment

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Study locations

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

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 4, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03039634
Lead sponsor
Sienna Labs
Responsible party
Sponsor
First posted
Feb 1, 2017
Start date
Aug 2016
Primary completion
May 2018
Completion
May 2018
Last update
Mar 4, 2019

Study contacts

Paul Lizzul, MD
study director · Sienna Biopharmaceuticals

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2018. You cannot join it, but the record below documents what was studied.

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