Minoxidil Response Testing in Females With Female Pattern Hair Loss
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 300
- 试验地点
- 5
- 主要终点
- Sensitivity and specificity of the minoxidil response in-vitro diagnostic kit to predict at baseline the change in Target Area Hair Count
研究概览
简要总结
The primary purpose of this study is to evaluate the clinical validity of the minoxidil response in-vitro diagnostic kit.
详细描述
Topical minoxidil is the only US FDA approved drug used for the treatment of AGA in females. While topical minoxidil exhibits a good safety profile, the efficacy in the overall population remains relatively low i.e., 30-40% re-grow hair. To observe significant improvement in hair growth, minoxidil is typically used once daily for a period of at least 24 weeks. Due to the significant time commitment and low response rate, a diagnostic test to identify non-responders prior to initiating therapy would be advantageous.
Minoxidil is converted in the scalp to its active form, minoxidil sulfate, by the sulfotransferase enzyme SULT1A1. The enzyme expression is variable among individuals. We have demonstrated in two prior feasibility studies that the SULT1A1 enzyme activity in plucked hair follicles correlates with minoxidil response in the treatment of AGA and thus can server as a predictive biomarker.
Consequently, we developed a minoxidil response in-vitro diagnostic kit intended to identify non-responders prior to initiating therapy with 5% topical minoxidil foam.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Females in overall good health
- •Age: 18 or older
- •Female pattern hair loss
- •Willing to have a mini dot tattoo placed in the target area of the scalp
- •Willing to maintain the same hair style, color, shampoo and hair products use, and approximate hair length throughout the study
- •Able to give informed consent
- •Able to comply with the study requirements for 24 consecutive weeks
- •Willing to use an adequate method of birth control (if applicable)
- •Negative urine pregnancy test
排除标准
- •Previous adverse event from topical minoxidil treatment
- •History of hypotension
- •Uncontrolled hypertension
- •Pregnant, nursing, or planning a pregnancy during the study
- •Prior hair transplant
- •Uses wigs or hair weaves
- •Have used minoxidil (topical or oral) anytime during the past 6 months
- •Chronic scalp disorders that require medications
- •Uses medication known to cause hair thinning such as Coumadin and anti-depressants/anti-psychotics
- •Folliculitis
- •Scalp psoriasis
- •Seborrheic dermatitis
- •Inflammatory scalp conditions such as lichen planopilaris
- •Enrolled in any other medical study or has been enrolled in any medical study in the past 6 months
研究组 & 干预措施
Predicted as non-responders
Patients that the minoxidil response in-vitro diagnostic kit predicted as non-responders. 5% minoxidil topical foam will be administered to subjects in this group.
干预措施: 5% minoxidil topical foam (Drug)
Predicted as responders
Patients that the minoxidil response in-vitro diagnostic kit predicted as responders. 5% minoxidil topical foam will be administered to subjects in this group.
干预措施: 5% minoxidil topical foam (Drug)
结局指标
主要结局
Sensitivity and specificity of the minoxidil response in-vitro diagnostic kit to predict at baseline the change in Target Area Hair Count
时间窗: baseline to week 24
Number of hairs measured in the target area by macrophotography.
Sensitivity and specificity of the minoxidil response in-vitro diagnostic kit to predict at baseline the subjects ratings
时间窗: baseline to week 24
次要结局
- Sensitivity and specificity of the minoxidil response in-vitro diagnostic kit to predict at baseline the change in Target Area Hair Count(baseline to week 12)
- Mean change in minoxidil sulfotransferase activity in plucked hairs as measured by the minoxidil response in-vitro diagnostic kit(baseline to week 24)
- Sensitivity and specificity of the minoxidil response in-vitro diagnostic kit to predict at baseline the treatment efficacy evaluated by expert panel review of global photographs assessing hair regrowth(baseline to week 24)
- Sensitivity and specificity of the minoxidil response in-vitro diagnostic kit to predict at baseline the mean change in non-vellus hair diameter in the target region(baseline to week 24)