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

Acne Vulgaris Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03039634
• Other study ID #: SL-2016-01_FA
• Status: Completed
• Start date: August 2016
• Est. completion date: May 2018

Study information

• Verified date: May 2018
• Source: Sienna Labs
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 76
• Est. completion date: May 2018
• Est. primary completion date: May 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Acne Vulgaris

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Sienna Labs

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	18 weeks post final treatment
Primary	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).	24 weeks post final treatment
Primary	Safety as assessed by number of adverse events	Adverse events will be monitored throughout the study	up to 24 weeks post final treatment