NCT00437151已完成4 期
An Analysis of Adherence and Associated Factors in Subjects Undergoing Differin® Gel, 0.1% Treatment of Moderate to Severe Acne Vulgaris.
适应症
干预措施
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Galderma R&D
- 入组人数
- 61
- 试验地点
- 1
- 主要终点
- Efficacy - Percent adherence calculated from MEMS Caps readings
研究概览
简要总结
The primary objective of this study is to investigate potential differences in treatment adherence by teenagers among four interventions during treatment for acne.
详细描述
Same as above.
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 (Outcomes Assessor)
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
- •Adolescent subjects with a diagnosis of moderate to severe Acne vulgaris
排除标准
- •Subjects with acne conglobata, acne fulminans, secondary acne (chloracne, drug-induced acne, etc.), or severe acne requiring more than topical treatment (e.g. oral isotretinoin)
研究组 & 干预措施
1
Active Comparator
More frequent than normal office visits
干预措施: More frequent than normal office visits (Other)
2
Active Comparator
Electronic reminders (voice, e-mail, text messages)
干预措施: Electronic reminders (voice, e-mail, text messages) (Other)
3
Active Comparator
Parental involvement / intervention reminders
干预措施: Parenteral involvement / intervention reminders (Other)
4
Active Comparator
No intervention or reminders
干预措施: No intervention or reminders (Other)
结局指标
主要结局
Efficacy - Percent adherence calculated from MEMS Caps readings
时间窗: 12 weeks
次要结局
- Safety - tolerability and adverse event reporting(12 weeks)
- Efficacy - lesion counts; percent adherence as calculated by product weights and by Subject's Diary; Global Severity Assessment; Global Assessment of Improvement; Subject questionnaire(12 weeks)
研究者
研究点 (1)
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