Đánh giá hiệu quả điều trị viêm da dầu ở đầu của dầu gội Thái Dương 3 và Thái Dương 7 (A Randomized, Double Blind, Placebo Controlled, Parallel Group, Phase 3 Trial to Evaluate the Safety and Efficacy Shampoos TD03 and TD07 in Scalp Diseases)
试验速览
- 阶段
- 3 期
- 入组人数
- 366
- 试验地点
- 1
- 主要终点
- Change from baseline in IGA scale at 4 week-treatment
研究概览
简要总结
Scalp Conditions are common chronic skin inflamations with the occurence rate of 1 - 5 % among the population. TD03 shampoo and TD07 shampoo are widely used to avoid hair loss with successful rate reaching nearly 95%. This trial is going to evaluate the efficacy of getting rid of dandruff as well as the safety of the investigational products in comparison to a reference (ketoconazole 2%) during a 4-week treatment period.
详细描述
Scalp Conditions are common chronic skin inflamations with the occurence rate of 1 - 5 % among the population. TD03 shampoo and TD07 shampoo are widely used to avoid hair loss with successful rate reaching nearly 95%. With herbal ingredients including Gleditsia, Morus alba, Ocimum tenuiflorum, Oroxylum indicum, Ageratum conyzoides, the investigational products could reduce the severity of inflamation, infection and help to prevent hair loss. This trial is planning to evaluate the efficacy of the IPs in terms of inflamation reduction, dandruff reduction on subjects using the IPs compared to a reference (ketoconazole 2%).
The trial is intended to last for 18 months with subject visits and 3 arms (122 subjects per arm). The first arm receive TD3 while TD7 is provided to the second arm in comparison to the placebo of the last arm. It will be conducted at National Hospital of Dermato - Venerology, Vietnam.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •> 18 years old and signed the ICF.
- •Diagnosed with head skin inflamtion with IGA <=
- •Voluntary sign the ICF before any procedures.
- •No hypersentivity to the IP.
排除标准
- •Use oral antifungal 1 month prior to the trial participation or topical antifungal 2 weeks prior to the trial participation.
- •Suffering chronic or acute diseases that may affect the trial.
研究组 & 干预措施
TD3
TD3, bi-daily x 4 weeks
干预措施: TD03 (Other)
TD7
TD7, bi-daily x 4 weeks
干预措施: TD07 (Other)
Ketoconazole 2%
Ketoconazole 2% shampoo bi-daily x 4 weeks
干预措施: Ketoconazole 2% Shampoo (Drug)
结局指标
主要结局
Change from baseline in IGA scale at 4 week-treatment
时间窗: 4 weeks
Change from baseline in IGA scale at 4 week-treatment of TD3 and TD7 compared to that of Ketoconazole 2% shampoo.
The numbers of subjects with AE/SAE
时间窗: 4 weeks
The numbers of subjects with AE/SAE as defined in the protocol.
次要结局
未报告次要终点