A Randomized Controlled Trial Investigating the Pediatric Patient Experience of Subantimicrobial Dose Doxycycline for Acne Treatment
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 22
- 试验地点
- 1
- 主要终点
- Patient Perceptions of Their Acne Treatment
研究概览
简要总结
Antibiotic resistance is a public health problem that worsens the more physicians prescribe standard dose antibiotics for acne. Regardless of race, acne vulgaris is one of the most common dermatologic conditions among pediatric populations. As such, clinicians can make a large impact by practicing good antibiotic stewardship while still addressing the impact of acne on adolescents' self-esteem. Subantimicrobial doxycycline maintains its anti-inflammatory effects while eliminating antimicrobial properties and associated risks of drug resistance. Few studies, focused primarily on adults, have shown that subantimicrobial doxycycline is efficacious in treating acne from a physician standpoint. The investigators aim to investigate the patient experience of acne treatment with subantimicrobial dose doxycycline in the pediatric population.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 13 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Documented moderate to severe facial acne
排除标准
- •Other skin conditions on the face
- •Previous antibiotic treatment for acne
- •Use of antibiotics for any reason within the past month
- •Use of new prescription regiment for acne within the last 3 months
- •Positive pregnancy test in the clinic
- •Cognitive impairments
研究组 & 干预措施
100 mg standard dose doxycycline BID
Oral, 12 weeks
干预措施: Doxycycline Hyclate (Drug)
20 mg sub-antimicrobial dose doxycycline BID
Oral, 12 weeks
干预措施: Doxycycline Hyclate (Drug)
结局指标
主要结局
Patient Perceptions of Their Acne Treatment
时间窗: 12 weeks
Biweekly Qualtrics surveys were administered to identify changes in the self-reported severity of facial acne lesions using a 10-point ordinal Likert-type scale at 7 post-prescription time point (week 0, week 2, week 4, week 6, week 8, week 10, week 12). The minimum value is 1 and the maximum value is 10, with increasing acne severity (i.e. 10 is most severe acne). * In the table below, participants are labelled by a letter (A, B, etc.) to differentiate the different time points (rows) but participants in each treatment group (100 mg vs 20 mg) are different and not related. * Data is missing for timepoints when surveys were not submitted
次要结局
未报告次要终点
研究者
Michelle Gallagher
Assistant Professor
Michigan State University