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临床试验/NCT04793945
NCT04793945Unknown4 期

The Efficacy of Combining 308 Nm-Excimer Light and Topical Steroid in the Treatment of Alopecia Areata

Assiut University0 个研究点目标入组 30 人开始时间: 2021年4月1日最近更新:
适应症

试验速览

阶段
4 期
入组人数
30
主要终点
digital photographs

研究概览

简要总结

Alopecia areata is a polygenic autoimmune disease causing hair loss, particularly during the anagen phase of hair growth This condition has a lifetime risk of about 2.1% of the world population and the cumulative incidence seems to rise linearly with age .

Patchy non scarring hair loss on the scalp is the most common clinical presentation, although it can also occur elsewhere . In addition to patchy Alopecia Areata , a more severe form, alopecia totalis , presents with diffuse hair loss across the scalp. In the most severe form, alopecia universalis , hair loss occurs on all areas of the body, including the beard, eyelashes, and extremities .

详细描述

Alopecia Areata can have a large impact on patients' quality of life, causing both cosmetic and psychosocial distress. Studies on the impact of hair loss have shown high levels of self-consciousness, jealousy, embarrassment, depression, introversion, and decreased self-esteem .

Alopecia Areata can occur at any age, but it is most common among young and middle-aged people . Both sexes are equally affected. Several environmental factors have been suggested as triggering Alopecia Areata, including infection, drugs, trauma, and stress. Thyroid autoimmune disease, atopy, and vitiligo are commonly associated. Diverse physical or psychological insults may trigger the episodes of Alopecia Areata, but there is no evidence that they influence prognosis.

Etiology of Alopecia Areata is not completely understood, and the majority of evidence suggests that genetically predisposed individuals, when exposed to an unknown trigger, develop a predominantly autoimmune reaction, leading to acute hair loss.

Although many patients improve spontaneously or respond to standard therapy, treatment can be quite challenging in those with more severe and refractory disease .

Topical corticosteroids are often the first line of treatment for mild patchy alopecia, with the underlying mechanism being containment of inflammation and hastening of the recovery of damaged hair follicles . Additionally, corticosteroids may be delivered via intralesional injection with slightly better effects (63% with complete regrowth within 4 months in one study . However, this method cannot be used for rapidly progressing variants and does not prevent hair loss at other sites . Furthermore, both topical and intralesional steroids increase the risk of cutaneous atrophy at the site of treatment, and intralesional steroids may decrease bone mineral density .

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
16 Years 至 40 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • aged 16-40 years,
  • Good general health,
  • A clinical diagnosis of multiple Alopecia Areata of the scalp.
  • Hair loss <25 percent of the total scalp.
  • No use of drugs or hair care products influencing hair growth in the last 2 months.

排除标准

  • Other causes of hair loss (like endocrine or immunological diseases).
  • Skin disease in the treatment area.
  • Pregnant or lactating patients.
  • Hair transplantation history.
  • Photosensitivity history.
  • Malignant tumor history.

结局指标

主要结局

digital photographs

时间窗: 9months

using identical camera settings, lighting, patient positioning and background.

The hair regrowth in the patches of alopecia

时间窗: 9months

0 = no hair regrowth, 1. = 1-25percent hair regrowth, 2. = 26-50percent hair regrowth, 3. = 51-75percent hair regrowth, and 4. = 76-100 percent hair regrowth.

A patient satisfaction score

时间窗: 9months

0 to 25percent change = not satisfied, 26 to 50percent = mildly satisfied, 51 to 75percent = moderately satisfied, 76 to 100percent = very satisfied

adverse effects

时间窗: 9months

Any encountered adverse effects in terms of pain, erythema, edema and crusts will be recorded.

Severity of ALopecia Tool score

时间窗: 9months

The scalp is divided into four parts on the basis of surface area as follows: vertex or top = 40 percent (0.40), right side = 18 percent (0.18), left side = 18 percent (0.18) and the posterior aspect = 24 percent (0.24). Percentage of hair loss in any of the four areas was multiplied by the percentage of the scalp covered in that area. The Severity of Alopecia Tool score is the sum of the percentage of hair loss in all the areas mentioned above.\[10\]

Dermoscopic evaluation

时间窗: 9months

Dermoscopy will be used to analyze the change in the count of hair at intervals of 4 weeks. The number of hair (total, vellus, and terminal hairs) will be calculated by dermoscopy .

dermoscopic evaluation

时间窗: 9months

The mean diameter of hair will be recorded for analysis.

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

fatma magdy zidan taraaf

principle investigator

Assiut University

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