Effectivness of Topical Tacrolimus 0.03% Monotherapy in Patients With Vitiligo: Arandomized Controlled Trial
试验速览
- 阶段
- 1 期
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Vitiligo Area Scoring Index (VASI)
研究概览
简要总结
The study will evaluate the effectiveness of Tacrolimus 0.03% ointment monotherapy in patients with vitiligo. Patients will be treated for 6 months and followed for 3 months after treatment. All types of vitiligo will be included.
详细描述
Study approval: The study was submitted for approval by Scientific and Ethical Committee at Faculty of Medicine, Sohag University. An informed written consent will be obtained from all participants.
Study design: randomized controlled trial. Study population: the study will include patients who attend the outpatient Clinic of Dermatology & Venereology and Andrology, Faculty of Medicine, Sohag University in corporation with Farshot General Hospital. Women who are pregnant or lactating, children aged 2 years or less and patients with acute or chronic disease that might affect skin barrier function will be excluded.
Patients and methods:
Study participants will be randomly divided into two treatment groups: group A will receive 0.03% tacrolimus ointment and group B will receive hydrocortisone acetate 1% ointment twice daily for 6 months.
Patients will be evaluated at baseline and monthly intervals for 6 months and at 3 months after stopping treatment.
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
- 2 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •all patients with clinical diagnosis of vitiligo
排除标准
- •children =or <2 years old, women who are pregnant or lactating, patients with acute or chronic disease that might affect skin barrier function.
研究组 & 干预措施
Tacrolimus group
Tacrolimus 0.03% ointment twice daily for 6 months
干预措施: Tacrolimus 0.03% Ointment (Drug)
Hydrocortisone group
hydrocortisone acetate 1% ointment twice daily for 6 months
干预措施: Hydrocortisone Acetate 1% Ointment (Drug)
结局指标
主要结局
Vitiligo Area Scoring Index (VASI)
时间窗: basline to 9 months
* The percentage of vitiligo involvement for each body region is calculated by using the palmar method. The palmar method uses the palmar surface area of the patient's hand as an estimation guide and defines the surface of the patient's hand including fingers to be 1% of the total body surface area. * The extent of residual depigmentation is expressed by the following percentages: 0, 10%, 25%, 50%, 75%, 90%, or 100%. * At 100% depigmentation, no pigment is present; at 90%, specks of pigment are present; at 75%, the depigmented area exceeds the pigmented area; at 50%, the depigmented and pigmented areas are equal; at 25%, the pigmented area exceeds the depigmented area; at 10%, only specks of depigmentation are present. * VASI= ∑ \[HAND UNITS\] × \[RESIDUAL DEPIGMENTATION\].
次要结局
- Vitiligo Disease Activity (VIDA) Score(baseline to 9 months)
研究者
Aml Abd Elaziz Ahmed
Dermatology Resident in Farshot General Hospital, Qena, Egypt
Sohag University