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临床试验/NCT03707236
NCT03707236撤回不适用

The Use of Teledermatology in the Treatment of Patients With Severe Acne on Isotretinoin: A Randomized-controlled Trial

Massachusetts General Hospital0 个研究点开始时间: 2023年4月1日最近更新:
适应症

试验速览

阶段
不适用
状态
撤回
主要终点
Change in total inflammatory lesion count

研究概览

简要总结

This is a non-blinded randomized controlled non-inferiority trial designed to assess the efficacy and role of teledermatology visits in the treatment of patients with severe acne starting isotretinoin. Males and females 16 years or older will be randomized to either the control arm (monthly office visits during treatment weeks 8-20) or treatment arm (teledermatology visits during treatment weeks 8-20). The primary outcome is the change in total inflammatory lesion count. Secondary outcomes include changes in acne severity based on the Leeds scale, patient satisfaction, acne severity as perceived by the patient, cost and time-lost to patients and families, need for interim and unexpected urgent appointments, adverse medication effects. The investigators are hypothesizing that patients randomized to the treatment arm will have no statistically significant difference in total inflammatory lesion count or acne severity than the control arm. The investigators also hypothesize that adverse events will be equivalent in both groups and the treatment arm will report less cost associated with visits.

详细描述

The role of telemedicine in dermatology is ever-expanding. Currently, teledermatology has been shown to be advantageous in disease processes that require frequent office follow-up visits such as psoriasis. In 2010, Watkins et al. demonstrated that teledermatology was effective in treating patients 16 years and older with moderate acne and demonstrated equivocal clinical outcomes as traditional office visits along with equivocal patient and provider satisfaction scores. More recently, Fruhauf et al. conducted a small study examining patients with severe acne on isotretinoin and found similar results in terms of safety and efficacy. Patients with severe acne on isotretinoin therapy currently are scheduled for monthly office visits in the dermatology clinic for at least six consecutive months during which time the severity of their acne is assessed by a dermatologist and dose adjustments are made accordingly. Patients are also required to get monthly laboratory studies immediately before, during, or after their visit, and this must be reviewed by the provider prior to prescription renewal according to iPledge guidelines. Given the fact that this medication is typically prescribed to teenagers or young adults, the high frequency of office visits put a significant burden on both patients and their families and results in unnecessary time missed from work or school.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
None

入排标准

年龄范围
16 Years 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients must have a diagnosis of severe acne by a dermatologist with a plan of initiating treatment with isotretinoin
  • Patients must first be enrolled in iPledge prior to eligibility

排除标准

  • Patients who have baseline hepatic dysfunction or hypertriglyceridemia
  • Patients with a history of depression, suicide attempts or suicidal ideation
  • Patients without access to internet or a camera (including portable camera and/or smart phone) at home
  • Patients who are pregnant - absolute contraindication

结局指标

主要结局

Change in total inflammatory lesion count

时间窗: Up to 24 weeks

Lesion counting involves counting the number of inflammatory lesions on the face, chest, or back. This excludes comedonal acne.

次要结局

  • Patient satisfaction(Up to 24 weeks)
  • Changes in acne severity(Up to 24 weeks)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Daniela Kroshinsky

Director of Inpatient Dermatology, Associate Professor of Dermatology

Massachusetts General Hospital

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