NCT06840470已完成4 期
Investigating the Effect of Topical Imiquimod on Sebaceous Hyperplasia
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 11
- 试验地点
- 1
- 主要终点
- Complete and 75% clearance rates (clearance refers to reduction in total lesional area) at 16 weeks of treated lesions
研究概览
简要总结
This study is being completed to determine if 8 weeks of treatment with imiquimod can shrink sebaceous hyperplasia.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient has sebaceous hyperplasia lesions on both sides of the face. At least one sebaceous hyperplasia lesion on each side of the face is 1 mm or more in size.
- •If of child-bearing potential, subject agrees to the use of highly effective contraception during study participation. For women of childbearing potential, acceptable pregnancy prevention measures will include abstinence, barrier methods, chemical methods, or surgical.
- •Ability to understand and willingness to sign a written informed consent
排除标准
- •Current use or prior use of a retinoid (e.g. tretinoin) within the last 4 weeks.
- •Prior use of imiquimod on the treated area.
- •Concurrent use of 5-fluorouracil, aminolevulinic acid (photodynamic therapy), or psoralen therapy, or use of any of these within the last 4 weeks.
- •Concurrent facial peels or cosmetic laser therapy on the treated areas.
- •Nursing, pregnant or planning to become pregnant.
- •Immunocompromised status (e.g. organ transplantation recipients or patients on cyclosporine).
- •Current participation in other investigational trials.
- •Known or suspected history of a clinically significant systemic disease (e.g., immunological deficiencies), unstable medical disorders (e.g., unstable diabetes), life-threatening disease or current malignancies.
- •Known hypersensitivity to any of the following (in any dosage form): imiquimod or any component of the study medications.
- •Received radiation therapy and/or anti-neoplastic agents within 3 months prior to study entry.
研究组 & 干预措施
Imiquimod
Experimental
Will be applied 3 times weekly ((i.e. Monday, Wednesday, and Friday prior to bedtime) to one side of the face.
干预措施: Imiquimod 5% Topical Cream (Drug)
No treatment
No Intervention
Lesions on the other side of the face will not be treated. Participants will have baseline and follow-up visits that will include photographs of the lesions.
结局指标
主要结局
Complete and 75% clearance rates (clearance refers to reduction in total lesional area) at 16 weeks of treated lesions
时间窗: 16 weeks
次要结局
- Mean change in Sebaceous Hyperplasia (SH) count(16 weeks)
- Mean change in Sebaceous Hyperplasia (SH) diameter(16 weeks)
- Adverse events (AE) associated with imiquimod 5% cream when used in the treatment of sebaceous hyperplasia(Up to 8 weeks)
研究者
Sunny Wong
Associate Professor of Dermatology
University of Michigan
研究点 (1)
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