NCT03039634已完成不适用
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
Sienna Labs0 个研究点目标入组 76 人开始时间: 2016年8月最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 76
- 主要终点
- Change in Total lesion count by blinded investigator
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Change in Total lesion count by blinded investigator
时间窗: 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).
Safety as assessed by number of adverse events
时间窗: up to 24 weeks post final treatment
Adverse events will be monitored throughout the study
次要结局
未报告次要终点
研究者
相似试验
招募中
3 期
Effect of topical silver sulfadiazine-cerium nitrate in treatment of moderate to severe burIRCT20190927044902N1Mashhad University of Medical Sciences112
已完成
3 期
Study About Effectiveness of Silver-Containing Textiles for Treatment of Acute NeurodermatitisNeurodermatitisNCT00196430University Medicine Greifswald32
终止
不适用
Efficacy Study of Antimicrobial Catheters to Avoid Urinary Infections in Spinal Cord Injured PatientsUrinary Tract InfectionNCT01803919Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau489
已完成
4 期
Comparison of Silver Modified and Conventional Atraumatic Restorative Treatment ModalitiesDental CariesNCT03881020Ain Shams University100
已完成
不适用
Efficacy of Silver based antiseptics application for decrease of Central Venous catheter infectionscatheter related infection profilaxis.Other and unspecified infectious diseasesIRCT201009014672N1Tehran Heart Center, Infection Control Section250