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临床试验/NCT05926882
NCT05926882已完成4 期

Efficacy of Oral Apremilast in the Treatment of Alopecia Areata at the Tertiary Care Hospital, Karachi.

Jinnah Postgraduate Medical Centre1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2022年8月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
入组人数
30
试验地点
1
主要终点
Efficacy of Oral Apremilast in the treatment of Alopecia Areata at the Tertiary Care Hospital, Karachi

研究概览

简要总结

Alopecia areata (AA) is a disease characterized by hair cycle dysfunction and the presence of peribulbar and perifollicular mononuclear cell infiltrate.1 The majority of patients report the rapid onset of one or several well-defined, usually round, 1 to 4 cm areas of scalp hair loss. A common feature is the presence of "exclamation-mark" hairs that are broken and short hairs that taper proximally.

Commonly used treatment modalities are steroids (intra-lesional, topical or systemic), contact immunotherapy, anthraline, minoxidil, calcineurine inhibitors, topical retinoids, systemic immune modulating agents, photo-chemotherapy, dermatography wigs and hypnotherapy etc Apremilast is a newer drug. It is an oral small-molecule inhibitor of phosphodiesterase 4 (PDE4), this may be effective treatment for a variety of inflammatory skin disorders such as alopecia areata.

详细描述

Due to its increasing prevalence and lack of local data on its long term management, the investigators designed current study On Efficacy of Oral Apremilast in Alopecia areata in-order to evaluate its effectiveness.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
20 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Either gender.
  • Age 20-70 years.

排除标准

  • Patients with history of connective tissue disorder, vasculitis, seropositive and seronegative arthritis
  • Patients with history of psoriasis.
  • Patients excluded from the study will be patients having history of previous treatments with some systemic agents

研究组 & 干预措施

Apremilast tablet

Experimental

Patients will be given Oral Apremilast 30 mg twice daily after 05 days initial titration dose. The effect of treatment will be evaluated using photographs of the patients before and after the study and clinical evaluation of patients.

干预措施: Apremilast 30mg (Drug)

结局指标

主要结局

Efficacy of Oral Apremilast in the treatment of Alopecia Areata at the Tertiary Care Hospital, Karachi

时间窗: It will be assessed upto 12 weeks

Efficacy of Oral Apremilast for 12 weeks in alopecia areata will be assessed by using SALT score ( Severity of Alopecia Tool). The SALT score is computed by measuring the percentage of hair loss in each of 4 areas of the scalp-vertex (40%), right profile (18%), left profile (18%), and posterior (24%)-and adding the total to achieve a composite score

次要结局

  • Mean difference of Salt score before and after the treatment(it will be assessed upto 12 weeks)

研究者

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

Dr. Parisa Sanawar

Principal Investigator

Jinnah Postgraduate Medical Centre

研究点 (1)

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