A Randomised, Evaluator-Blinded, Two-Arm Study To Evaluate The Safety And Efficacy of a Novel Microneedle and Laser-Based Medical Device For The Treatment of Androgenetic Alopecia in Adult Males
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 82
- 试验地点
- 2
- 主要终点
- Change in terminal hair density
研究概览
简要总结
The purpose of this 24-week study is to see if the SAGA-001 device is safe and effective at helping people with male pattern hair loss.
Two different device configurations are being explored as part of this study. Device A has novel microneedles, lasers, and additional metal microneedles, while Device B only has novel microneedles and lasers.
Participants will receive 12 treatments with either Device A or Device B over the course of 24 weeks. Treatments will be performed on-site every two weeks.
详细描述
Participants will have the medical tests or procedures described below:
- Subjects will be asked about their previous medical history and current medications.
- Brief physical examinations will be performed, including a visual inspection of the scalp.
- Questions about medical history (including previous and current medication use) will be asked.
- Two types of photos will be taken: 1) "global photos", which are general photos of the subject's scalp, and 2) "macro photos", which are close-up photos of a part of the subject's scalp.
- Questions about treatment-related issues or unpleasantness will be asked.
- Subjects will be asked to rate the improvement they see in their photos.
- Subjects will be asked to rate their satisfaction with the treatment.
Participants will also be asked to record changes in medications, changes in medical treatments, and major life changes (such as major dietary changes, exercise changes, changes in life stressors, etc.) in a diary for the duration of treatment. They should also make note of any suspected side effects or issues they believe are related to the treatment.
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
- Double (Participant, Investigator)
盲法说明
Participants will be randomly allocated at a 1:1 ratio to receive treatment with Device type A or B.
入排标准
- 年龄范围
- 22 Years 至 55 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Subject is willing to sign an informed consent form
- •Subject is within the age group of 22-55 years (including both ages)
- •Subject is male
- •Subject has AGA with a Stage IIa-V Hamilton-Norwood classification
- •Subject's skin is within Fitzpatrick Skin Types I-IV
排除标准
- •Subjects who have used any formulation or application/administration or type of treatment for disorders of the skin or scalp within 180 days prior to screening, including but not limited to the following treatments:
- •Anti-inflammatory medications, including topical steroids
- •Skin, nail, hair rejuvenation supplementation, or IV infusions (includes vitamin, minerals, herbals, etc.)
- •Hair growth shampoos, conditioners, and topicals
- •Topical, dermal or oral minoxidil, finasteride, or dutasteride
- •Hair growth stimulation treatments, i.e. PRP, stem cells, exosomes, growth factors, microneedling, mesotherapy
- •LED or low level laser therapy treatments, ie. laser helmets, laser caps, and laser combs
- •Infrared saunas
- •Subjects with alopecia other than AGA, such as alopecia areata, alopecia totalis, telogen effluvium, anagen effluvium, and acquired cicatricial alopecia
- •Subjects with a history of bleeding disorders
- •Subjects on anticoagulant medications (aspirin, warfarin, heparin)
- •Subject on autoimmune suppressant medications or suffering autoimmune diseases (e.g. humira)
- •Subjects with an active infection at the local site
- •Subjects with keloidal tendencies
- •Subjects with chronic dermatological conditions affecting the scalp (e.g. eczema, psoriasis, etc.)
- •Subjects with hepatic or renal disease, epilepsy, or any other major medical illness*
- •Subjects that have undergone evaluation to rule out other causes of hair loss, because underlying causes (e.g., iron deficiency, lupus, thyroid disease, telogen effluvium, post-pregnancy, polycystic ovary, chemotherapy, etc.) would preclude assessment of performance in an androgenetic alopecia trial
- •Subjects who are photosensitive or are using photosensitive drugs or topicals.
- •Subjects who are taking anxiolytics medications
- •Subjects who have been on hormone inhibitors or on hormone replacement therapy in the last 180 days
- •Subjects who are at high risk of seizures
- •Subjects who have a malignancy or a history of malignancies affecting the scalp
- •Subjects that have undergone hair transplantation, scalp reduction, radiation to the scalp or chemotherapy within their lifetime.
- •Subjects with current hair weaves, hair extensions, scalp tattoos, or who use occlusive wigs.
- •Subjects who have used semi-permanent hair products (e.g. color, texturizers or relaxers) within 30 days prior to screening.
- •Subjects with hair shorter than one-half inch (approximately 1.2 cm).
- •Subjects who are unable to make regular follow-up visits.
- •Subjects who are immediate family members (spouse, parent, child, or sibling; biological or legally adopted) of personnel directly affiliated with the study at the investigative sites, or individuals who are directly affiliated with the study at the investigative sites, or individuals directly affiliated with the study sponsor.
结局指标
主要结局
Change in terminal hair density
时间窗: 16 weeks
Changes in terminal hair density at the 16-week time point compared to baseline will be investigated using a binomial test for one proportion at a one-sided alpha with a 95% exact confidence interval, considering pi ≥ 60%, where pi is the true percentage of responders in the study population.
次要结局
- Change in hair thickness(24 weeks)