临床试验/CTRI/2024/01/062101

CTRI/2024/01/062101已完成4 期

Spirinolactone versus Bicalatumide in female pattern hair loss; a randomised clinical trial

Abhijeet Kumar Jha1 个研究点分布在 1 个国家目标入组 200 人开始时间: 2024年12月2日最近更新: 2025年2月27日

适应症

试验速览

阶段: 4 期
状态: 已完成
发起方
入组人数: 200
试验地点: 1
主要终点: Increase in hair density in 200 patients

研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

Female Pattern hair loss is characterised by decreased scalp hair density and progressive miniaturization of hair. follicles.

Aims: To compare safety and efficacy of Spirinolactone versus Bicalatumide in Female Pattern Hair Loss [FPHL]

Methods: All eligible female aged18 to 50 years with grade 2-5 Sinclair grade of FPHL will be recruited by randomisation. All treatment naive cases will be included. Global photographic assessment along with trichoscopic images will be captured at each follow up to study any change in hair density and number at each 4 week follow up.

研究设计

研究类型: Interventional
分配方式: Computer generated randomization
盲法: Investigator Blinded

入排标准

年龄范围: 18.00 Year(s) 至 50.00 Year(s)（—）
性别: Female

入选标准

•Treatment naive Grade 2-5 Female Pattern Hair loss.

排除标准

•Nursing and pregnant females History of topical minoxidil application History of malignancy History of any SSRI, antihypertensive, potassium supplement Any other hormonal therapy, oral contraceptive pills.

结局指标

主要结局

Increase in hair density in 200 patients

时间窗: 24 weeks

Adverse effects in 200 patients

时间窗: 24 weeks

次要结局

Increase in hair density in 200patients(Averse effects in 200 patients)

研究者

发起方

Abhijeet Kumar Jha

申办方类型

Government medical college

研究点 (1)

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