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临床试验/NCT07267273
NCT07267273招募中不适用

Effect of Betamethasone Phonophoresis in Treatment of Vitiligo

Cairo University1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2025年11月10日最近更新:
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
60
试验地点
1
主要终点
vitiligo Management

研究概览

简要总结

Vitiligo is a skin disorder that results in the formation of depigmented patches or hypopigmented macules due to selective destruction or reduction of melanocytes the cells that produce pigment in our skin.

Vitiligo affects 0.1-2% of the World's population. People of all skin types and all ages can be affecte. In most of the cases, white patches develop or expand slowly overtime, and in some cases it never progress and remains stable . Vitiligo can be segmental or non-segmental depending upon the morphology of the clinical involvement. It can also be classified as stable or unstable based on the activity of disease.

Steroids act as anti-inflammatory and immunosuppressant agents. Even if different classes of steroids are now available, the mid- potent ones (e.g. betamethasone dipropionate 0.05% cream, 0.05% clobetasol propionate ointment) are usually preferred for the treatment of young patients .

Now days, topical corticosteroids are the most commonly prescribed agents in treatment of dermatologic conditions .Almost all treatments of vitiligo have borrowed from therapies whose prime targets have been another disease.

详细描述

Many theories have been put forward to explain the pathogenesis of vitiligo and mechanisms that leads to the loss of functional melanocytes from the epidermis. The important ones include a genetic predisposition, autoimmune destruction of melanocytes, altered redox status and free radical mediated melanocyte damage, heightened sympathetic response and catecholamines/neurotransmitter mediated melanocyte damage, and impaired melanocyte adhesion or melanocytorrhagy.Mode of therapy is based on decreasing the activity, thereby achieving stability and later inducing pigmentation.

Vitiligo is classified into Segmental Vitiligo, Non-Segmental Vitiligo and Unclassified according to Vitiligo Global Issues Consensus Conference.Segmental vitiligo lesions are characterized by generally one and less commonly two or multiple segments. Most common form is Uni-segmental form which consists of one or more macules particularly on one side of the body with the involvement of body hair with early age of onset, and rapid stabilization while non-segmental vitiligo lesions are distributed bilaterally in an acrofacial pattern (i.e. affecting the face, hands or feet) or scattered symmetrically over the entire body .

Non-segmental vitiligo (NVS) comprises of acrofacial, generalized, universal, mixed forms. NVS can initially have an acrofacial distribution, which can later progress to the generalized or universal form. Acrofacial vitiligo can affect face, hands and feet and generally involve the perioral region and tips of the fingers. In a study of latent class analyses, two types of non-segmental vitiligo have been identified; the first is of early onset (i.e. before the 12 years of age) and generally associated with halo naevus with premature greying of hair, while second type is of late onset and is mostly associated with an acrofacial pattern. In generalized vitiligo, patient had a few acrofacial lesions for 10 years that evolved within 6 months into generalized form, spreading to the trunk. Universal Vitiligo affects about 80-90% of body surface area and is the most common form of vitiligo.

Generalized vitiligo usually precedes Universal vitiligo. Mixed vitiligo is defined as the combined involvement of both segmental and non-segmental vitiligo in one patient. Generally segmental vitiligo precedes the non-segmental vitiligo. Rare class is also considered as Un-classified type and consists of Follicular Vitiligo, Vitiligo Punctate and Vitiligo Minor. Vitiligo minor is likely to be limited to dark skinned individuals. The term minor here refers to incomplete pigmentation with pale skin compared with healthy skin .

The presence of focal lesions (i.e., small isolated white macule) with no segmental distribution that have not evolved into non-segmental or segmental vitiligo after 1-2 years but can evolve to segmental vitiligo or non-segmental vitiligo is regarded as unclassifiable vitiligo .

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
25 Years 至 40 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Male and female patients diagnosed with vitiligo.
  • Medically and psychologically stable patients.
  • Good cognitive abilities to understand the requirements of the study.
  • All patients enrolled to the study will have their informed consent.
  • they had no contraindications to the use of therapeutic ultrasound

排除标准

  • Pregnancy or lactation.
  • Immunosuppression.
  • Alcohol abuse.
  • History of spontaneous re-pigmentation of lesions.
  • Presence of skin characteristics that may interfere with study assessment.
  • Active bacterial/viral infection.
  • Patients on other immune suppressants and phototherapy
  • Patients currently participating in any other clinical study
  • Uncooperative patients.

研究组 & 干预措施

Patients Group

Active Comparator

This group of patients composed of 30 Male and female patients who received betamethasone cream then after 20 minutes ultrasound was applied, three times per week for 1 month.

干预措施: Beclomethasone (Drug)

Control Group

Active Comparator

This group of patients composed of 30 Male and female patients who received ultrasound then after 20 minutes patients received betamethasone cream, three times per week for 1 month.

干预措施: Beclomethasone (Drug)

结局指标

主要结局

vitiligo Management

时间窗: 3 Months

Evaluation of the patients whom suffering from vitiligo and using betamethasone phonophoresis for the treatment of vitiligo using Vitiligo noticeability scale (VNC)

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Ola sabry Abd-Elmaksoud tarabya

Resident at Physical Therapy for Surgery

Cairo University

研究点 (1)

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