Combining Topical Imiquimod 5% Cream With a Pulsed Dye Laser to Treat Port Wine Stain Birthmarks
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 27
- 试验地点
- 1
- 主要终点
- Change From Baseline in a* and E at 8 Weeks
研究概览
简要总结
Port wine stains are red birthmarks that without treatment persist for a lifetime. They are frequently found on the face and can be conspicuous and disfiguring, negatively impacting social interactions for these patients. Treating Port wine stains is difficult. The standard of care is to use laser treatment, but over 80% of patients fail to completely clear despite multiple treatments. The growth of additional blood vessels (angiogenesis) following the Laser treatment is likely an important factor in why these lesions persist despite therapy.
详细描述
Imiquimod is a topical cream that affects the immune response and has been noted to inhibit blood vessel formation. It has been used to successfully treat other vascular growths such as hemangiomas. The research can use imiquimod cream 5% cream apply to port wine stains after laser therapy to improve lightening of port wine stains. The imiquimod 5% cream cream apply to Port wine stains everyday for 8 weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of Port Wine Stain birthmark
- •Male and female subjects of any age who are in good health.
- •Fitzpatrick skin type I-VI
排除标准
- •Pregnant or lactating
- •History of cutaneous photosensitivity
- •History of hypersensitivity to imiquimod 5% cream or any of its components
- •History of photodermatoses
研究组 & 干预措施
Imiquimod
Combining Topical Imiquimod 5% Cream With a Pulsed Dye Laser to Treat Port Wine Stain Birthmarks
干预措施: Imiquimod (Drug)
Placebo
Combining Topical Imiquimod 5% Cream With a Pulsed Dye Laser to Treat Port Wine Stain Birthmarks
干预措施: Placebo (Other)
结局指标
主要结局
Change From Baseline in a* and E at 8 Weeks
时间窗: 8 weeks baseline
Change in a\* and ΔE is a way to quantify PWS treatment outcome: a\* is the erythema of the vascular lesions and varies from +60 for green to -60 for red with a value of +9.28 for Normal Skin. Higher a\* values indicates a greater reduction in erythema hence better treatment outcome. ΔE detects all three dimensions of colorspace (L\*a\*b\*) and represents the difference in color between normal and PWS skin. Range of ΔE is 0 to 100. Higher values indicates improved treatment efficacy by greater skin color improvement.
次要结局
未报告次要终点
研究者
Beckman Laser Institute and Medical Center
Kristen Kelly, M.D., Professor Departments of Dermatology and Surgery
University of California, Irvine