Comparative Efficacy of Topical Tacrolimus Versus Tyrosine as Co-Therapy to NB-UVB in Vitiligo: A Randomized Intra-Individual Controlled Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 67
- 试验地点
- 1
- 主要终点
- Change in VESTA Score from Baseline to month 3
研究概览
简要总结
The goal of this clinical trial is to learn if adding topical tacrolimus or topical tyrosine to narrowband UVB phototherapy works to treat vitiligo in adults. It will also learn about the safety of both combinations.
The main questions it aims to answer are:
Which combination (UVB + tacrolimus or UVB + tyrosine) leads to greater skin repigmentation (color return) after 3 months of treatment? What side effects do participants experience with each combination? Researchers will compare three groups: UVB + tacrolimus, UVB + tyrosine, and UVB only to see which is more effective and safer.
Participants will:
Receive narrowband UVB phototherapy sessions two times per week at minimal erythema dose Apply either topical tacrolimus or topical tyrosine to their vitiligo patches twice daily Visit the clinic every one month for skin examination and photography Report any side effects or skin reactions
详细描述
Study Design and Setting:
This is a randomized, intra-individual (within-patient) controlled, open-label clinical trial conducted at the outpatient dermatology clinic of a university hospital in Egypt. The study duration is from August 2025 to February 2026. A total of 69 patients with vitiligo were enrolled, with 67 completing the study.
For each enrolled patient, three comparable vitiligo patches were identified on the patient's body. Each patch was randomly assigned to one of three treatment regimens, allowing each patient to serve as their own control.
Phototherapy Procedure:
Narrowband UVB (NB-UVB) phototherapy was administered to all patches simultaneously using a full-body cabinet. Treatment was given twice weekly for 3 months, starting at the minimal erythema dose (MED) with incremental increases of 10-20% per session based on erythema response. The same phototherapy protocol was applied uniformly to all three patches on each patient.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged 18-65 years with vitiligo who are candidates for narrowband UVB (NB-UVB) phototherapy.
排除标准
- •Pregnant or lactating women.
- •Patients who have received any systemic or topical treatment for vitiligo within the preceding three months.
研究组 & 干预措施
NB-UVB only
Narrowband UVB phototherapy twice weekly plus placebo vehicle cream applied twice daily for 3 months.
干预措施: Narrowband UVB Phototherapy (Device)
topical tyrosine 2% + NB-UVB
Narrowband UVB phototherapy twice weekly plus topical tyrosine 2% cream applied twice daily for 3 months.
干预措施: Narrowband UVB Phototherapy (Device)
topical tyrosine 2% + NB-UVB
Narrowband UVB phototherapy twice weekly plus topical tyrosine 2% cream applied twice daily for 3 months.
干预措施: Topical Tyrosine 2% cream (Drug)
topical tacrolimus 0.1% + NB-UVB
Narrowband UVB phototherapy twice weekly plus topical tyrosine 2% cream applied twice daily for 3 months.
干预措施: Narrowband UVB Phototherapy (Device)
topical tacrolimus 0.1% + NB-UVB
Narrowband UVB phototherapy twice weekly plus topical tyrosine 2% cream applied twice daily for 3 months.
干预措施: Topical Tacrolimus 0.1% ointment (Drug)
结局指标
主要结局
Change in VESTA Score from Baseline to month 3
时间窗: Baseline and after 3 months of treatment
The Vitiligo Extent Score by Target Area (VESTA) is a validated assessment tool that calculates the percentage of repigmentation within a target vitiligo patch. It accounts for both marginal and perifollicular repigmentation patterns. The score ranges from 0% (no repigmentation) to 100% (complete repigmentation). Higher scores indicate better treatment response.
次要结局
- Clinical Improvement grade(after 3 months of treatment)
- Incidence of Treatment-Related Adverse Events(From baseline to month 3 (through study completion))
研究者
Almostafa M Ahmed, MD
Lecturer of Dermatology and Venereology
Minia University