Comparision on efficacy of topical Tacrolimus 0 point 1 percent ointment with handheld narrow band ultraviolet B versus topical Calcipotriol 0 point 005 percent ointment with handheld narrow band ultraviolet B in treatment of vitiligo a randomized controlled study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 58
- 试验地点
- 1
- 主要终点
- The primary outcome of the trial is the percentage of repigmentation area in vitiligo patients, which is assessed using the VASI (Vitiligo Area Scoring Index) score
研究概览
简要总结
This study is a randomized controlled trial aimed at comparing the efficacy and safety of topical Tacrolimus 0.1% ointment combined with handheld narrowband ultraviolet B (NBUVB) phototherapy versus topical Calcipotriol 0.005% ointment combined with handheld NBUVB phototherapy in the treatment of vitiligo. The primary purpose is to evaluate which treatment combination offers superior repigmentation and fewer side effects in vitiligo patients. The hypothesis is that both treatment combinations are effective, but the study seeks to determine if one is superior in efficacy and safety profile.
The study aims to provide clearer guidance for optimizing clinical management of vitiligo with these topical and phototherapy combinations.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 6.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients clinically diagnosed with vitiligo.
- •Age above six years.
- •Body surface area involvement less than twenty percent.
- •Willing to provide written informed consent or assent for minors.
排除标准
- •Not willing to participate.
- •Pregnant or lactating women.
- •Other autoimmune dermatological disorders.
- •Allergy to tacrolimus or calcipotriol.
- •Photosensitivity or contraindication to phototherapy.
结局指标
主要结局
The primary outcome of the trial is the percentage of repigmentation area in vitiligo patients, which is assessed using the VASI (Vitiligo Area Scoring Index) score
时间窗: The outcomes are evaluated at multiple timepoints during the study, but the most specific timepoint of primary interest appears to be the 3 months follow-up after initiating treatment
次要结局
- Documentation and assessment of adverse effects such as erythema, edema, itching, hypertrichosis, and acne-like papules.Evaluation of improvement by independent, blind third-party assessment using the Global Photographic Assessment (GPA) scale.The mean improvement in the VASI score by the physician (Mean Improvement Score by Physician, MISP).(3 MONTHS FOLLOW UP)
研究者
PONNAGANTI PARVATHI ANNAPURNA
SRI DEVARAJ URS MEDICAL COLLEGE