NCT05536882撤回3 期
Randomized Controlled Trial Comparing the Efficacy of Adapalene 0.1% Gel to 10% Benzoyl Peroxide in Treating Molluscum Contagiosum.
适应症
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Complete clearance at 12 weeks
研究概览
简要总结
Non-blinded randomized controlled trial comparing efficacy of topical benzoyl peroxide 10% (vehicle choice per patient preference: e.g. gel, cream, lotion, wash) to topical adapalene 0.1% gel in the treatment of molluscum contagiosum in children aged 1 year old to 14 years old.
- Two treatment wings: topical benzoyl peroxide 10% (vehicle choice per patient preference) applied 1-2x daily as tolerated vs adapalene 0.1% gel applied 1-2x daily as tolerated.
- Primary outcome: Complete clearance at 12wks (defined as lack of identifiable papular molluscum contagiosum lesions on physical exam)
- Secondary outcomes: % change in lesion count at 12wks.
详细描述
- During the course of their normal workday, OU dermatology faculty and residents will be responsible for identifying and recruiting treatment-naïve patients being seen at the OU dermatology clinic for the diagnosis of molluscum contagiosum. These same faculty and residents will be responsible for approaching these patients regarding participation in the study. Chart review will not be a part of this selection process aside from what would naturally be done in the course of the patients' care. The same faculty and residents would be responsible for explaining the risks and benefits of study participation, obtaining written consent for study participation from a parent or guardian, obtaining verbal assent from patients aged 7-14 years old (as well as written assent for those capable of reading/writing), and randomizing patients to respective treatment wings using an online random number generator.
-
of MC lesions counted at time of recruitment, re-assessed at single follow up appointment at 12wks
- List of enrolled patients kept in excel spreadsheet on encrypted department shared drive. Data points added alongside patient names until all data points collected for an individual patient, then identifying information removed and replaced with a study number which will be used to refer to their de-identified data set going forward.
- Patients/caregivers would be responsible for obtainment and application of respective medications (both medications available over the counter for < $15)
- Primary and secondary outcomes will be assessed via Chi-square test
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
- 1 Year 至 14 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children aged 1 year to 14 years old seen in an OU Dermatology resident or faculty clinic and diagnosed with molluscum contagiosum who have not received prior treatment for this condition, and whose parent/guardian(s) desire treatment for this condition.
排除标准
- •Patients who have received prior treatment for molluscum contagiosum.
- •Patients with a history of adverse reaction to any topical retinoid, benzoyl peroxide, cinnamon, or other benzoic derivatives (e.g., salicylic acid, hydroquinone, catechol, vanillin).
- •Pregnant females.
- •Patients with caregivers who do not speak English.
- •Patients with caregivers who are unable to provide consent.
- •Patients who decline to assent for participation.
研究组 & 干预措施
Benzoyl peroxide
Experimental
topical benzoyl peroxide 10% (vehicle choice per patient preference) applied 1-2x daily as tolerated until complete clearance or 12 week follow up
干预措施: Benzoyl peroxide (Drug)
Adapalene
Active Comparator
adapalene 0.1% gel applied 1-2x daily as tolerated until complete clearance or 12 week follow up
干预措施: Adapalene Gel (Drug)
结局指标
主要结局
Complete clearance at 12 weeks
时间窗: 12 weeks
Defined as lack of identifiable papular molluscum contagiosum lesions on physical exam at 12 week follow up visit
次要结局
- % change in lesion count at 12 weeks(12 weeks)
研究者
研究点 (1)
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