NCT06355856尚未招募4 期
Phase IV, National, Unicentric, Comparative, Double-Blind, Randomized, Non- Inferiority Clinical Trial to Evaluate the Efficacy and Safety of DNN.22.17.036 Compared to 10573048700 in the Treatment of Androgenetic Alopecia
Ache Laboratorios Farmaceuticos S.A.0 个研究点目标入组 196 人开始时间: 2024年4月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 196
- 主要终点
- Percentage variation of hairs in the hair loss phase
研究概览
简要总结
Evaluation of the efficacy and safety of DNN.22.17.036 versus 10573048700 in the treatment of male pattern hair loss.
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
- 25 Years 至 60 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Ability to understand and consent to participate in this clinical research, expressed by signing the Informed Consent Form (ICF)
- •Male participants age 25 or older and 60 age or younger
- •Participants who have an intact scalp in the area of product analysis
- •Participants with androgenetic alopecia (AGA) with AGA Norwood-Hamilton Scale > II
- •Participants with at least 20% telogen effluvium of evaluated by Tricholab
排除标准
- •Participants who have used immunosuppressants in the 3 months prior to signing the ICF
- •Participants with other causes of hair loss or scalp dermatoses
- •Participants who have received hair loss treatment in the last 6 months
- •Participants with uncontrolled medical conditions, kidney and liver disease
- •Participants with a history of hair transplantation, malignancy, hematologic disorders, thyroid dysfunction, malnutrition, and other dermatologic disorders that contribute to hair loss
研究组 & 干预措施
DNN.22.17.036
Experimental
Apply 1 ml to the bald area of the scalp, twice a day for 180 days.
干预措施: DNN.22.17.036 (Drug)
10573048700
Active Comparator
Apply 1 ml to the bald area of the scalp, twice a day for 180 days.
干预措施: 10573048700 (Drug)
结局指标
主要结局
Percentage variation of hairs in the hair loss phase
时间窗: 180 days
Percentage variation of hairs in the hair loss phase (telogen hairs), by image analysis with the FotoFinder Leviacam®, after 180 days of treatment.
次要结局
未报告次要终点
研究者
相似试验
已完成
2 期
An Effectiveness And Safety Study Of PD 0299685 For The Treatment Of Symptoms Associated With Interstitial CystitisInterstitial CystitisPainful Bladder SyndromeNCT00739739Pfizer161
已完成
3 期
Clinical Trial to Evaluate the Efficacy and Safety of D064 and D702 Combination TherapyEssential HypertensionNCT05931224Chong Kun Dang Pharmaceutical346
已完成
2 期
Subcutaneous Treatment In Randomized Subjects To Evaluate Safety And Efficacy In Generalized Lupus ErythematosusLupus Erythematosus, SystemicNCT01405196Pfizer183
已完成
2 期
To Reverse ENDocrine Resistance Trial - PD 0332991 Monotherapy vs PD 0332991 in Combination With the Endocrine TherapyBreast CancerNCT02549430Fondazione Sandro Pitigliani115
Unknown
3 期
Evaluate the Efficacy and Safety of DWJ1506 and DWJ1507DyslipidemiasNCT04772443Daewoong Pharmaceutical Co. LTD.280