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临床试验/NCT02905851
NCT02905851已完成不适用

Teledermatology and Modulation of Antibiotic Dose in Acne Vulgaris

University of California, Davis2 个研究点 分布在 1 个国家目标入组 4 人开始时间: 2016年5月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
4
试验地点
2
主要终点
Reduced antibiotic use

研究概览

简要总结

To see if teledermatology can be used to reduce antibiotic burden in patients on doxycycline or minocycline for acne vulgaris

详细描述

The investigators are going to ascertain if antibiotic burden can be reduced with tele dermatology use.

There are two arms of the study:

  1. Feedback group
  2. Non feedback group

All subjects will be randomised to either group, all subjects will take photos of their face and answer questions at baseline, visit 2 (1 month), visit 3 (2 months), visit 4 (3 months).

The investigators will then use measurements of acne grading (patient grading, investigator global assessment, lesion counting, global acne grading) to reduce/taper antibiotics in the feedback group.

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
15 Years 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Subjects aged 15 years and older
  • Subjects who have been prescribed doxycycline or minocycline by their physician for acne vulgaris but have not initiated treatment yet.

排除标准

  • Subjects who have used isotretinoin in the last 6 weeks
  • Those who have used oral antibiotics within the last 4 weeks
  • Those who have been initiated or changed brand of oral contraceptive pill within the last one month.
  • Those subjects who cannot engage with the teledermatology platform
  • Prisoners
  • Adults unable to consent

研究组 & 干预措施

Non Feedback

Placebo Comparator

No feedback given to this group regarding their antibiotic use Subjects take images and answer questions during the study like the feedback group, but in this group no feedback re dosing is given.

干预措施: Non Feedback group (Other)

Feedback group

Active Comparator

Feedback given to this group regarding their antibiotic use after baseline.

If the subject is in the feedback group, after this visit, a dermatologist will review all images and the survey results and give the patient information about whether they should:

  1. Continue current dose
  2. Reduce dose if there is at least a one point improvement in both the investigator acne global assessment AND the patient acne global assessment scores: A dose reduction will be such that the dose is halved from the previous dose. For example if the subject is on minocycline or doxycycline 100 mg twice daily, they will be reduced to minocycline or doxycycline 100 mg daily.
  3. Increase dose if had been previously reduced, dose will not be increased beyond the initial starting dose.

干预措施: Feedback group (Other)

结局指标

主要结局

Reduced antibiotic use

时间窗: Assessed at 4, 8, 12 weeks

The difference in antibiotic exposure in the physician feedback group compared to those not receiving feedback

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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