Use of Botulinum Toxin in the Treatment of Androgenic Alopecia

Zel Skin and Laser Specialists1 个研究点分布在 1 个国家目标入组 20 人开始时间: 2022年8月12日最近更新: 2024年3月27日

适应症

干预措施

试验速览

阶段: 2 期
状态: 进行中（未招募）
发起方
入组人数: 20
试验地点: 1
主要终点: Changes from baseline in Average hairs per follicular unit (average number of hairs within a hair follicle).

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

The purpose of this study is to evaluate the effect of using a purified botulinum toxin (Xeomin®, Merz, USA), the same injectable used to improve face wrinkles, to treat a specific type of hair loss seen in men and women not associated with scarring or other internal disease called 'pattern hair loss'. This type of hair loss is medically called 'androgenic or androgenetic alopecia'. In men it is typically called 'male pattern baldness' whereas in women it is called 'female pattern baldness' and in both cases is hereditary meaning there will be a history of relatives that describe having the same condition.

详细描述

Adult volunteers aged 22-55 years presenting with mild to moderate patterned hair loss will be screened for participation. Twenty subjects (10 males and 10 females) meeting the inclusion/exclusion criteria will be recruited to participate. Prior to any injections a global photograph documenting the patterned hair loss will be acquired for each individual utilizing the Canfield global camera system. Each subject will then undergo trichoscopy imaging within the defined treatment area using the Canfield HairMetrix® system. The imaged area is at a higher magnification capable of reliable measurements for hair density (count/cm2), hair shaft diameter, follicular units, among other measurements captured by the software. Individual balding scalps will be outlined and mapped to include up to 30 injection sites evenly distributed within the hair loss area.

At each site, 5 Units of Xeomin® will be injected with a maximum of 150 Units total per subject. This will be a single, one-time treatment session. Consequently, subjects will be contacted by phone or will be asked to come into the clinic for follow up according to a set schedule.

At each follow up visit (monthly) subjects will be asked to report any adverse events. Follow up visits at the clinic will also include photographic documentation, trichoscopy, and investigator and subject subjective reporting of treatment progress.

There will be a total of up to 3 injectors, 1 person taking photographs (including trichoscopy), and 1 investigator assessing treatment outcome.

During this 9 month-long study, subjects cannot utilize other hair loss treatments and must maintain their grooming routine which includes maintaining their hair style.

研究设计

研究类型: Interventional
分配方式: Na
干预模型: Single Group
主要目的: Treatment
盲法: None

入排标准

年龄范围: 22 Years 至 55 Years（Adult）
性别: All
接受健康志愿者: 否

入选标准

•Subjects must be diagnosed by the investigator with mild to moderate degree of hair-pattern loss (androgenic alopecia). Mild to moderate will be defined by investigator assessment of III Vertex-V on the Norwood Scale ( for males) or 3-6 on the Savin Scale (for females).
•Subjects must be between 22-55 years of age with mild to moderate AGA with no known medical conditions that, in the investigator's opinion, may interfere with study participation.
•Subjects must agree to maintain the same hair grooming and style routine during study participation.
•Sexually active females of childbearing potential participating in the study must agree to use a medically-acceptable method of contraception while receiving study product. A woman of childbearing potential is defined as one who is biologically capable of becoming pregnant; including perimenopausal women who are less than 2 years from their last menses. Exception: Sexually inactive females of childbearing potential are not required to practice a reliable method of contraception and may be enrolled at the investigator's discretion, provided that they understand the possible risks involved in getting pregnant during the study and are counseled to remain sexually inactive for the duration of the study or to practice a reliable method of contraception if becoming sexually active during the study.
•Subjects must sign a written informed consent.
•Subjects must sign a photo release form.

排除标准

•Any systemic treatment for hair loss within the last 6 months including hormonal therapy for peri-menopausal females.
•Concurrent therapy with any medication either topical or oral that might, in the investigator's opinion, interfere with the study.
•Subjects under current treatments in study area with light therapy, microneedling, Platelet-rich Plasma, prostaglandin analogues, ketoconazole, hair transplant or any method deemed unacceptable by the investigator.
•Any history of drug interaction, such as, aminoglycoside antibiotics, penicillamine, quinine and calcium channel blockers
•Subjects who have demonstrated a previous hypersensitivity reaction to any of the ingredients of the study products.
•History of allergic reaction to similar products (Botox® or Dysport®)
•Albumin sensitivity (allergy to eggs)
•Subjects with any signs of infection at the injection sites
•Active cold or sinus infection
•Any dermatologic or systemic disorder, which in the investigator's opinion, may interfere with the treatment. Examples of such disorders include neuromuscular disorders, hypertrophic scarring, keloidal scarring, bleeding disorders, subjects on immunosuppressive medications, and lupus erythematosus.
•Subjects who are pregnant, breast feeding or planning a pregnancy during the study period.
•Subjects who are unwilling or unable to comply with the requirements of the protocol.
•Participation in another research study (currently or within the last 30 days).
•All volunteers unwilling to sign the consent forms after being informed of their obligations and risks that they might encounter as a participant in this study.

研究组 & 干预措施

Single treatment with Xeomin® (incobotulinumtoxin A)

Experimental

Individual balding scalps will be outlined and mapped to include up to 30 injection sites evenly distributed within the hair loss area. At each site, 5 Units of Xeomin® will be injected with a maximum of 150 Units total per subject. This will be a single, one-time treatment session.

干预措施: incobotulinumtoxin A (Drug)

结局指标

主要结局

Changes from baseline in Average hairs per follicular unit (average number of hairs within a hair follicle).