Comparative Efficacy of CO2 Laser-Assisted Topical Tofacitinib Delivery Combined with Excimer Laser Versus Topical Tofacitinib with Excimer Laser for Acral Vitiligo: A Randomized, Intraindividual Trial.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- NA
- 入组人数
- 20
- 试验地点
- 1
研究概览
简要总结
Acral vitiligo is among the most treatment resistant forms of vitiligo, largely due to poor drug penetration, low follicular reservoir, and reduced melanocyte density in acral areas. Phototherapy remains central to vitiligo management, but its effectiveness in acral lesions is limited. Tofacitinib, a JAK inhibitor, provides targeted immune modulation by blocking interferon gamma CXCL10 signaling, thereby reducing T cell mediated melanocyte destruction. Tofacitinib also works synergistically with phototherapy, as light promotes melanocyte regeneration and complements immune suppression. Fractional CO2 laser enhances this approach by creating microchannels that improve drug delivery and by stimulating melanocyte proliferation, migration, and repigmentation through wound healing pathways. Therefore, combining fractional CO2 laser assisted topical tofacitinib delivery with excimer laser phototherapy may improve both drug absorption and pigment restoration, offering a potentially superior treatment option compared to topical tofacitinib with excimer therapy alone for resistant acral vitiligo.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 50.00 Year(s)（—）
- 性别
- All
入选标准
- •Phototherapy naïve adults aged 18–50 years with clinically diagnosed acral vitiligo (affecting hands and/or feet).
- •Stable vitiligo for at least 6 months prior to enrolment, defined by no new lesions or expansion of existing lesions.
- •Vitiligo Disease Activity (VIDA) score of 0–1, indicating stable or minimally active disease.
- •Symmetric or comparable bilateral acral lesions suitable for intraindividual comparison
- •Willingness to comply with study procedures and avoid other vitiligo treatments during the trial.
排除标准
- •Active or progressive vitiligo (VIDA score greater than 1).
- •History of hypersensitivity to tofacitinib, laser therapy, or excimer light.
- •Concomitant skin conditions (e.g., psoriasis, eczema) that could interfere with assessments.
- •Systemic immunosuppressive therapy within 4 weeks or topical treatments (including JAK inhibitor) within 4 weeks prior to enrolment.
- •Comorbidities such as active infection, malignancy, or severe hepatic/renal impairment.
- •Pregnancy, lactation, or inadequate contraception in women of childbearing potential.