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临床试验/NCT05954104
NCT05954104已完成不适用

Evaluation of the Effect of Topical Calcipotriol Versus Platelet-Rich Plasma Versus Combined of Both on Serum Adiponectin Level in Alopecia Areata

Egymedicalpedia1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2023年7月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
80
试验地点
1
主要终点
Efficacy of topical calcipotriol and platelet Rich Plasma in Alopecia Areata treatment

研究概览

简要总结

Alopecia areata (AA) is a common, immune-mediated non scarring alopecia and can be associated with severe psychological consequences . Alopecia Areata affects 2% of the global population. Alopecia Areata prevalence is lower in adults than children, is increasing over time, and significantly differs by region.

Its etiology is unknown but it was hypothesized to be an autoimmune disease mediated by T-lymphocytes. It has been suggested that inflammatory T cells induce growth arrest in hair bulbs in the anagen phase of the hair cycle . Cytotoxic T cells secrete tumor necrosis factor, granzymes, and Fas ligand which trigger apoptosis in affected hair follicle and disrupt hair growth

详细描述

Clinically, Alopecia Areata presents as a well-circumscribed patch of sudden hair loss. It affects any hair bearing area. The most common affected site is the scalp .

Dermoscopy is a highly valuable tool in diagnosis and follow-up of Alopecia Areata. The most common trichoscopic features of Alopecia Areata are yellow dots, micro exclamation mark hairs, tapered hairs, black dots, broken hairs, and regrowing upright or regrowing coiled hairs .

The diagnosis of alopecia areata is commonly established based on clinical appearance, In cases of ambiguity, trichoscopy may be useful to avoid invasive procedures such as biopsy.

Treatment of alopecia areata is dependent on age of patient as well as the extent and duration of scalp involvement. Treatments include steroids, topical immunotherapy, topical minoxidil, anthralin, and immunosuppressants. Each case must be dealt with on a customized individual basis.

Platelets rich plasma (PRP) is an autologous preparation of platelets in concentrated plasma. Injection of PRP improves cutaneous ischemic conditions, increases vascular structures around hair follicles and induces the proliferation of dermal papilla cells by up regulating fibroblast growth factor 7 (FGF-7) .Anagen-associated angiogenesis has been suggested as one of the important factors in active hair growth, due to the secretion of vascular endothelial growth factor by the keratinocytes of the outer root sheath and fibroblasts of the dermal papilla .

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
Triple (Participant, Investigator, Outcomes Assessor)

入排标准

年龄范围
5 Years 至 50 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Patients with non-severe alopecia areata , a severity of alopecia tool (SALT) score up to 2 with less than 50% of scalp involvement.
  • No restriction of age , race, nor occupation

排除标准

  • Pregnant and lactating women, immunocompromised patients.
  • Patients having active scalp inflammation.
  • Patients who received systemic treatment for Alopecia Areata in the last 3 months or applied any topical or intradermal treatments in the last 4 weeks .

研究组 & 干预措施

Group A

Active Comparator

About 20 patients suffering from Alopecia areata , they will receive topical vit D3 analogue (calcipotriol) 0.005% twice daily for 3 months with follow up

干预措施: Calcipotriol (Drug)

Group B

Active Comparator

About 20 patients suffering from Alopecia areata , they will be injected by PRP intra lesional for 3 consecutive sessions 4weeks apart.

干预措施: Calcipotriol (Drug)

Group C

Active Comparator

About 20 patients suffering from Alopecia areata they will receive combined therapy ( PRP and topical vit D3 analogue).

干预措施: Calcipotriol (Drug)

Group D

Active Comparator

About 20 of Healthy control group .

干预措施: Calcipotriol (Drug)

结局指标

主要结局

Efficacy of topical calcipotriol and platelet Rich Plasma in Alopecia Areata treatment

时间窗: from baseline to 3 months

Evaluating the patients suffering from Alopecia Areata clinically, with Severity of Alopecia Tool (SALT) score. As score of 0 means no hair loss, while a SALT score of 100 is complete hair loss. and this evaluation will be done by trichoscopy

次要结局

  • serum adiponectin level.(from baseline to 3 months)
  • serum Adiponectin level in Alopecia Areata(from baseline to 3 months)

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (1)

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