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临床试验/NCT05577637
NCT05577637已完成1 期

Comparitive Study Between Uvb Phototherapy Alone and Uvb Photothearpy With Topical 0.03% Tacrolimus for Treatment of Vitiligo

Combined Military Hospital Abbottabad1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2021年5月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
1 期
状态
已完成
发起方
入组人数
60
试验地点
1
主要终点
effectiveness of 0.03% topical tacrolimus with uvb phototherapy and placebo with uvb photothreapy is calculated through repigmentation using a formula {% re-pigmentation = Present % depigmentation ÷ Baseline % depigmentation x 100}

研究概览

简要总结

Vitiligo is a skin disorder that causes substantial social and psychological distress due to multiple patches of depigmentation.Disease can target at any age, but it appears to affect various parts of body due to loss of melanin. Although the exact cause of the disease is unknown, several theories suggest that genetic predisposition, autoimmunity, and increased vulnerability of melanocytes to the deleterious effects of harmful metabolites all play a role in disease causation. It impacts 0.1%-2% of the general population, with a 30% familial prevalence rate.

Vitiligo treatment still presents a therapeutic challenge for dermatologists despite a variety of therapeutic modalities. Topical steroids, ultraviolet B phototherapy (UVB 280nm-320nm), and photochemotherapy (PUVA i.e., psoralen plus UVA 329nm-400nm) are traditional treatment options. Topical calcipotriol and excimer laser are also used. According to research, narrowband UVB (NB-UVB) is effective when used alone.

Few studies, however also, have reported more than 75% re-pigmentation in patients treated with NB-UVB in conjunction with other modalities. Topical immunomodulators (tacrolimus, pimecrolimus) are considered safe and effective long-term treatments for vitiligo because they do not cause skin atrophy, which is associated with long-term use of topical corticosteroids. Tacrolimus is an effective treatment for vitiligo when used alone; in one study, 61% of patients showed more than 75% repigmentation when treated with tacrolimus alone. Another study found that when tacrolimus was combined with NB-UVB, 73% of patients experienced more than 50% repigmentation.

The objective of this research was to present a comparatively new mode of treatment that may be beneficial to vitiligo patients.

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
20 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • patients having 20-60 years of age
  • non pregnant
  • no history of photosensitivity
  • no history of immunosuppression or immunosuppressive drugs
  • no histry of steroids use oral or topical in last four weeks

排除标准

  • pregnancy
  • lactation
  • history of photosensitivity
  • photo-aggravated dermatoses
  • history of any immunosuppressive disorder or use of immunosuppressive medicine
  • history of using steroids either oral or injectable within the previous one month
  • history of skin malignancy

研究组 & 干预措施

group A topical tacrolimus 0.03% with uvb phototherapy

Active Comparator

Group A :contain 30 patients who have been treated with topical 0.03% tacrolimus twice daily at night and then received uvb phototherapy thrice weekly for 12 weeks

干预措施: 0.03% tacrolimus twice daily was applied on group A patients with uvb phototherapy thrice daily (Drug)

Group B topical placebo twice daily with uvb phototherapy thrice weekly

Active Comparator

Group B :contain 30 patients received uvb phototherapy only thrice weekly for 12 weeks

干预措施: 0.03% tacrolimus twice daily was applied on group A patients with uvb phototherapy thrice daily (Drug)

结局指标

主要结局

effectiveness of 0.03% topical tacrolimus with uvb phototherapy and placebo with uvb photothreapy is calculated through repigmentation using a formula {% re-pigmentation = Present % depigmentation ÷ Baseline % depigmentation x 100}

时间窗: 12 weeks

repigmentation assesed by {% re-pigmentation = Present % depigmentation ÷ Baseline % depigmentation x 100}

次要结局

未报告次要终点

研究者

发起方
Combined Military Hospital Abbottabad
申办方类型
Other
责任方
Principal Investigator
主要研究者

Rohida Rahmat

principle investigator

Combined Military Hospital Abbottabad

研究点 (1)

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