Daily Topical Rapamycin Therapy for the Treatment of Vitiligo
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Number of lesions with no response
研究概览
简要总结
In current Dermatology practice, options for vitiligo remain limited. The purpose of this study is to determine if once daily dosed topical rapamycin is effective for the treatment of patients with vitiligo. Participants will apply either 0.1% topical rapamycin or 0.001% topical rapamycin for six months to a lesion on one side of the body, and topical placebo to a corresponding lesion on the opposite side of the body. The study also aims to evaluate patient satisfaction and identify any adverse effects on these dosing regimens.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
The pharmacy will distribute medications in unlabeled, 60-gram tubes following patient enrollment. Tubes will be marked as "Left" and "Right." The association between tube label and treatment type will only be known to pharmacy staff. The pharmacy staff will allocate 10 patients to receive 0.001% rapamycin and 10 patients to receive 0.1% rapamycin.
入排标准
- 年龄范围
- 13 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients 13 years of age and older
- •Patients with nonsegmental vitiligo
排除标准
- •Patients with segmental or mucosal vitiligo
- •Patients with contraindication to use of rapamycin
- •Patients with history of transplant
- •Patients with a history of natural immunodeficiency
- •Patients with a history of artificially induced immunodeficiency
- •Patients with a history of a serious or life-threatening infection
- •Patients taking CYP3A4 inhibiting medications
- •Patients taking strong CYP3A4 inducers
- •Patients undergoing current treatment for vitiligo
- •Women that are or may become pregnant
研究组 & 干预措施
Topical rapamycin 0.001%
Patients randomized to this arm of the study will apply 2 finger tip units (FTU) or 0.5 cc topical rapamycin 0.001% cream daily for 6 months
干预措施: Rapamycin (Drug)
Topical rapamycin 0.1%
Patients randomized to this arm of the study will apply 2 FTU (0.5 cc) topical rapamycin 0.1% cream daily for 6 months
干预措施: Rapamycin (Drug)
Placebo
All patients will apply 2 FTU (0.5 cc) topical placebo cream daily for 6 months to the corresponding anatomic location on the opposite side of the body where the experimental drug is not being applied
干预措施: Placebo (Drug)
结局指标
主要结局
Number of lesions with no response
时间窗: 6 months
Absence of change in appearance of targeted lesion. Vitiligo is a depigmenting disease and treatment responses are graded by percentage of repigmentation on a 5-point scale
Numbers of lesions with complete response
时间窗: 6 months
Targeted lesion is no longer grossly visible.
Number of lesions with partial response
时间窗: 6 months
There is change in the size of dyspigmentation as compared to its appearance and symptoms at the initial visit, but the lesion remains grossly visible. Vitiligo is a depigmenting disease and treatment responses are graded by percentage of repigmentation on a 5-point scale. Changes in the characteristics of the targeted lesions will be evaluated by a dermatologist and documented via photographs at follow-up visits at 2, 4, and 6-months, with the final outcome measured at the 6-month visit.
次要结局
- Average score of Dermatology Quality of Life questionnaire (or Teenager Quality of Life Index)(6 months)
研究者
Chelsea Shope
Medical/Dental Resident
Medical University of South Carolina