A Novel Method for Improving Acne Outcomes
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- The Measured Adherence by the MEMS Cap in Relation to the Patient Reported Adherence Via the Internet Survey.
研究概览
简要总结
This is an investigator-blinded, prospective study of 20 subjects aged 13 through 18 with mild to moderate acne. Study subjects will be randomized to an internet survey group, in which an email link for a survey ascertaining the status of the subject's acne is sent weekly, or to a control group. All study subjects will use benzoyl peroxide 5% gel, and adherence and clinical improvement will be monitored over 12 weeks. The investigators hypothesis is that subjects in the internet survey group will have improved adherence to the study medication and clinical outcomes, because the weekly survey will remind subjects to use their medication.
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
- Single (Investigator)
入排标准
- 年龄范围
- 13 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •male or female 13 to 18 years of age with a diagnosis of mild to moderate acne vulgaris by a dermatologist.
- •written consent of participation must be given by parent or guardian and child.
排除标准
- •Age less than 13 or greater than 18 years of age.
- •Known allergy or sensitivity to topical benzoyl peroxide gel in the subject.
- •Inability to complete all study-related visits.
- •Introduction of any other prescription medication, topical or systemic, for acne vulgaris while participating in the study.
- •Subjects may not use topical retinoids or other benzoyl peroxide products, including Proactiv® or topical prescription medications while enrolled in the study.
- •Women that are actively trying to become pregnant or wish to become pregnant during the time frame the study is to take place will be excluded.
- •Subjects will be carefully selected for this study and only those deemed appropriate for treatment with benzoyl peroxide will be placed on this medication.
研究组 & 干预措施
Internet survey
Subjects will receive a weekly email link to complete an internet survey about their acne and use of the study medication.
干预措施: Internet survey (Behavioral)
Internet survey
Subjects will receive a weekly email link to complete an internet survey about their acne and use of the study medication.
干预措施: Benzoyl peroxide 5% gel (Drug)
Control
Subjects will receive standard-of-care treatment with the study medication, without internet surveys.
干预措施: Benzoyl peroxide 5% gel (Drug)
结局指标
主要结局
The Measured Adherence by the MEMS Cap in Relation to the Patient Reported Adherence Via the Internet Survey.
时间窗: 12 weeks
Adherence will be objectively measured with the Medication Event Monitoring System (MEMS) cap and the percentage of prescribed doses taken will be reported. Study subjects' self-reported adherence (in the intervention group, via the weekly internet survey) will be compared to objectively measured adherence via MEMS caps. Adherence was monitored objectively with electronic monitors that recorded the date and time when the medication containers were opened (medication event monitoring system caps). Adherence was rated as a percentage of days the medication container was opened; adherence could be greater than 100% if the container was opened more than once per day.
次要结局
- The Change (Dynamic Assessment) in the Acne Global Assessment From Baseline to End of Study.(Baseline to 12 weeks)
- The Change (Dynamic Assessment) From Baseline to End of Treatment in Lesion Counts.(Baseline to 12 weeks)
- The Measured Adherence by the MEMS Cap in Relation to the Change (Dynamic Assessment) in the Acne Global Assessment.(12 weeks)