Evaluation of a non-steroidal peripherally selective androgen receptor antagonist: oral bicalutamide in female pattern hair loss
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 84
- 试验地点
- 1
- 主要终点
- Change in hair density number of terminal hairs per cm square from baseline to the end of the treatment period measured by standardized global scalp photography and dermoscopy
研究概览
简要总结
This study titled Evaluation of a Non Steroidal Peripherally Selective Androgen Receptor Antagonist Oral Bicalutamide in Female Pattern Hair Loss aims to assess the efficacy of oral bicalutamide alone and in combination with topical minoxidil in improving hair growth among female patients aged 20 to 50 years diagnosed with FPHL Existing treatments such as minoxidil and oral antiandrogens have variable outcomes and notable side effects highlighting the need for safer more effective alternatives The study will be conducted over 18 months and will include 84 participants divided into three groups bicalutamide alone minoxidil alone and combination therapy Baseline and follow-up assessments will be done at 8 12 and 20 weeks including clinical photography trichoscopy hair density measurement and patient satisfaction scoring using standardized scales Sinclair Ludwig and Patient Global Assessment By comparing changes in hair density grading scores and patient reported outcomes the study seeks to establish the therapeutic potential and safety of oral bicalutamide as a novel treatment option for female pattern hair loss
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Outcome Assessor Blinded
入排标准
- 年龄范围
- 20.00 Year(s) 至 50.00 Year(s)（—）
- 性别
- Female
入选标准
- •Female patients diagnosed with FPHL.
- •Willingness to comply treatment and follow- up schedule.
排除标准
- •Pregnant or lactating women.
- •Prior use of antiandrogens or hormone therapies in the last 6 months.
- •Patients with other types of alopecia, both cicatricial and non cicatricial.
- •Patients with uncontrolled diabetes, uncontrolled hypertension, and other medical disorders (cardiac, renal, hepatic, immunocompromised, epilepsy).
结局指标
主要结局
Change in hair density number of terminal hairs per cm square from baseline to the end of the treatment period measured by standardized global scalp photography and dermoscopy
时间窗: 8 weeks 12 weeks and 20 weeks
次要结局
- To compare changes in Sinclair and Ludwig grading scores across the three groups(8 weeks 12 weeks and 20 weeks)
研究者
Dr Shaik Sana Sultana
Alluri Sitarama Raju Academy of Medical Sciences