A comparative study to evaluate the efficacy and safety of oral spironolactone versus oral bicalutamide for the treatment of adult female acne-a randomised control trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
研究概览
简要总结
This is a prospective, open-label, randomized controlled trial conducted to compare the efficacy and safety of oral spironolactone and oral bicalutamide in adult female patients with moderate to severe acne. A total of 60 eligible participants will be randomized in a 1:1 ratio to receive either oral spironolactone 100 mg once daily or oral bicalutamide 25 mg once daily for 12 weeks. Patients will be followed up at regular intervals up to 16 weeks. Efficacy will be assessed using the Clinician Global Assessment (CGA) score for acne, and safety will be evaluated by monitoring adverse drug reactions and relevant laboratory parameters. The study aims to generate evidence to guide optimal hormonal therapy for adult female acne.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 25.00 Year(s) 至 45.00 Year(s)（—）
- 性别
- Female
入选标准
- •Adult female patients aged more than 25 years with clinically diagnosed moderate to severe acne vulgaris as assessed by the Clinician Global Assessment score, willing to provide written informed consent and comply with follow-up visits.
排除标准
- •Pregnant or lactating women; patients aged less than 25 years; patients unwilling to provide informed consent or comply with follow-up; patients with renal impairment, hyperkalemia, liver dysfunction or known hypersensitivity to spironolactone or bicalutamide; patients who have received systemic antiandrogens, oral isotretinoin or systemic antibiotics for acne in the preceding 3 months; patients who have received topical acne therapy in the preceding 1 month; and patients planning pregnancy within the next 6 months.
研究者
Dr Bhavya Kaliki
Bangalore Medical College and Research Institute