NCT07166354尚未招募1 期
Clinical Study of mTOR Inhibitor as a Treatment for Grey Hair (Canities)
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 入组人数
- 100
- 主要终点
- Greying Severity Score
研究概览
简要总结
Clinical Study to Assess the Safety and Efficacy of CS-002 (mTOR inhibitor) as a treatment for Canities (Grey Hair)
详细描述
CS-002 is a small molecule that is an mTOR ("mammalian target of rapamycin ") inhibitor. In vitro and a small pilot study demonstrated re-pigmentation of grey hair following CS-002 application. The aim of this study is to assess the safety and efficacy of CS-002 as a treatment for grey hair.
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
- 30 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 30 to 65
- •Diagnosed with Grey Hair (Canities)
- •Willing and able to apply the treatment as directed, comply with study
- •Otherwise healthy
- •Able to give informed consent
排除标准
- •A medical history that may interfere with study objectives
- •Women who are pregnant, lactating, or planning to become pregnant during the study period
- •Subjects who have experienced a clinically important medical event within 90 days of the visit (e.g., stroke, myocardial infarction, etc)
- •Subjects who have known allergies to any excipient in CS-001
- •Subjects who are currently participating in another clinical study or have completed another clinical study with an investigational drug or device in the treatment area within 30 days prior to study treatment initiation
- •Subjects who have used any topical prescription medications in the treatment area within 30 days prior to study treatment initiation
- •Subjects who have had a dermatological procedure such as surgery in the treatment area within 30 days prior to study treatment initiation
- •Subject is unable to provide consent or make the allotted clinical visits
研究组 & 干预措施
CS-002
Experimental
CS-002 Topical Treatment
干预措施: CS-002 (Drug)
Placebo
Placebo Comparator
Placebo Topical Treatment
干预措施: Placebo Topical Solution (Drug)
结局指标
主要结局
Greying Severity Score
时间窗: Week [0,24]
Greying Severity Score (GSS). Mild Greying score between 0-5, Moderate Greying score between 6-10 and Severe Greying score between 11-15
次要结局
未报告次要终点
研究者
相似试验
终止
1 期
Phosphatidylinositol 3 Kinase and Mammalian Target of Rapamycin (PI3K-mTOR) in Advanced Cancer PatientsAdvanced CancersNCT00877773M.D. Anderson Cancer Center44
已完成
2 期
Study of RAD001 in Adenoid Cystic CarcinomaAdenoid Cystic CarcinomaNCT01152840Seoul National University Hospital33
已完成
3 期
Efficacy and Safety of the Mammalian Target of Rapamycin (mTor Rapamycin) Inhibitor in Vascular MalformationsCardiovascular AbnormalitiesNCT01811667Cliniques universitaires Saint-Luc- Université Catholique de Louvain19
已完成
2 期
CCI-779 in Treating Patients With Stage IIIB (With Pleural Effusion) or Stage IV Non-Small Cell Lung CancerRecurrent Non-small Cell Lung CancerStage IIIB Non-small Cell Lung CancerStage IV Non-small Cell Lung CancerNCT00079235National Cancer Institute (NCI)50
已完成
1 期
Vaccine Therapy With or Without Sirolimus in Treating Patients With NY-ESO-1 Expressing Solid TumorsAnaplastic AstrocytomaAnaplastic OligoastrocytomaAnaplastic OligodendrogliomaEstrogen Receptor NegativeEstrogen Receptor PositiveHormone-Resistant Prostate CancerMetastatic Prostate CarcinomaMetastatic Renal Cell CancerRecurrent Adult Brain NeoplasmRecurrent Bladder CarcinomaRecurrent Breast CarcinomaRecurrent Colorectal CarcinomaRecurrent Esophageal CarcinomaRecurrent Gastric CarcinomaRecurrent Hepatocellular CarcinomaRecurrent Lung CarcinomaRecurrent MelanomaRecurrent Ovarian CarcinomaRecurrent Prostate CarcinomaRecurrent Renal Cell CarcinomaGlioblastomaRecurrent Uterine Corpus CarcinomaResectable Hepatocellular CarcinomaStage IA Breast CancerStage IA Ovarian CancerStage IA Uterine Corpus CancerStage IB Breast CancerStage IB Ovarian CancerStage IB Uterine Corpus CancerStage IC Ovarian CancerStage II Uterine Corpus CancerStage IIA Breast CancerStage IIA Lung CarcinomaStage IIA Ovarian CancerStage IIB Breast CancerStage IIB Esophageal CancerStage IIB Lung CarcinomaStage IIB Ovarian CancerStage IIB Skin MelanomaStage IIC Ovarian CancerStage IIC Skin MelanomaStage IIIA Breast CancerStage IIIA Esophageal CancerStage IIIA Lung CarcinomaStage IIIA Ovarian CancerStage IIIA Skin MelanomaStage IIIA Uterine Corpus CancerStage IIIB Breast CancerStage IIIB Esophageal CancerStage IIIB Ovarian CancerStage IIIB Skin MelanomaStage IIIB Uterine Corpus CancerStage IIIC Breast CancerStage IIIC Esophageal CancerStage IIIC Ovarian CancerStage IIIC Skin MelanomaStage IIIC Uterine Corpus CancerStage IV Bladder Urothelial CarcinomaStage IV Esophageal CancerStage IV Ovarian CancerStage IV Prostate CancerStage IV Skin MelanomaStage IVA Uterine Corpus CancerStage IVB Uterine Corpus CancerSarcomaNCT01522820Roswell Park Cancer Institute18