A Pilot Study Evaluating the Safety and Efficacy of a Fractionated Thulium Laser and KeraFactor for the Treatment of Alopecia
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 2
- 主要终点
- Percentage of subjects with score of 2 or 3 on Subject Global Aesthetic Improvement at week 12 of treatment.
研究概览
简要总结
The objective of this clinical study is to assess the safety and efficacy of using a laser and hair growth factors in the treatment of male-pattern hair loss. Participating subjects will receive up to two (2) treatments per month for 6 months with the laser and post-treatment topically applied hair growth factors and will have a 6 month follow-up period.
详细描述
This is a single-center, open-label, baseline-controlled, study evaluating the use of a Thulium laser (1927nm) and post-treatment topically applied KeraFactor, which contain hair-stimulating growth factors, in the treatment of androgenetic alopecia. The study may enroll up to 20 subjects looking for improvement in their hair loss. Multiple treatment areas per subject may be included. Each subject will receive up to two (2) treatments per month over a 3-month period. Follow Up Visits are planned for 3, and 9 months post last treatment. Standardized photography of the treatment areas will be recorded Pre and Post Treatment at each visit. Measurement outcomes will be compared to baseline. During the initial visit, subjects who meet the study's eligibility criteria will receive the first treatment after signing informed consent form.
The follow up phase will consist of before and after photographs graded by blinded observers. Subjects are instructed to inform clinical staff after the treatment if they experience any adverse events.
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
盲法说明
No masking.
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subject must voluntarily sign and date an IRB approved informed consent form
- •Subjects with diagnosis of androgenetic alopecia with hair loss recorded over the past 6 months. (Ludwig Savin Scale: Class I-4, II-1, II-2 for females and Norwood Hamilton Class 3-4 for males
- •Able to read, understand and voluntarily provide written informed consent.
- •Healthy male or female, ≥ 18 years of age at time of informed consent up to 65 years of age, seeking treatment for hair loss.
- •Subject is determined to be healthy, non-smoker who agrees not to make any changes to their daily hair treatment regime during the study.
- •Subjects able and willing to comply with the treatment protocol and follow-up schedule and requirements.
- •Understands and accepts the obligation not to undergo any other procedures in the areas to be treated through the follow-up period.
- •Women of child-bearing age are required to be using a reliable, non-hormonal method of birth control for the duration of the study. Subjects will be asked to have a negative Urine Pregnancy test at baseline.
排除标准
- •Subjects does not have the capacity to consent to the study
- •Subject has other types of alopecia of the scalp (i.g., alopecia areata, scarring alopecia)
- •Use of minoxidil or 5-alpha reductase inhibitors (i.e., finasteride, dutasteride) 3 months prior to screening date.
- •Any medical condition that in the consideration of the investigator, would present an increased risk of a photosensitivity reaction to the subject.
- •Pregnant in the last 12 months, intending to become pregnant, postpartum or nursing in the last 12 months.
- •Any previous surgical procedure in the treatment area in the past 12 months, or major surgery in the last 6 months.
- •History of immunosuppression/immune deficiency disorders (including AIDS and HIV infection), and/or any history of systemic chemotherapy for prior 12 months.
- •History or current use of the following prescription medications: Immunosuppressive medications/biologics, 6 months prior to and during the study. Accutane or other systemic retinoids within the past twelve months.
- •Smoking or vaping in the past 12 months.
- •History of hyperlipidemia, diabetes mellitus, hepatitis, or bleeding disorders.
- •History of major depressive disorders or endocrine disorders including but not limited to; hypothyroidism, Hashimoto's thyroiditis, or hyperthyroidism as well as Polycystic Ovarian Syndrome (PCOS) in females.
结局指标
主要结局
Percentage of subjects with score of 2 or 3 on Subject Global Aesthetic Improvement at week 12 of treatment.
时间窗: 12 weeks
Subject Global Aesthetic Improvement Scale (SGAIS) is a Likert scale, ranging from "greatly decreased (-3)" hair growth to "greatly increased (+3)" hair growth. 1. Greatly decreased (-3) 2. Moderately decreased (-2) 3. Slightly decreased (-1) 4. No change (0) 5. Slightly increased (+1) 6. Moderately increased (+2) 7. Greatly increased (+3) Subjects will be given a hand mirror for self-assessment of post-treatment hair growth compared to subject's pre-treatment scalp photographs.
Percentage of subjects with score of 2 or 3 on Clinician Global Aesthetic Improvement (CGAIS) scale at week 12 of treatment.
时间窗: 12 weeks
Clinician Global Aesthetic Improvement Scale (CGAIS) is a Likert scale, ranging from "greatly decreased (-3)" hair growth to "greatly increased (+3)" hair growth. 1. Greatly decreased (-3) 2. Moderately decreased (-2) 3. Slightly decreased (-1) 4. No change (0) 5. Slightly increased (+1) 6. Moderately increased (+2) 7. Greatly increased (+3) Based on a live assessment of the subject while referring to the subject's pre-treatment scalp photographs, the clinician will make an assessment of post-treatment hair growth.
次要结局
- Reported pain score on Numeric Rating Scale for Pain(12 weeks)
- Percentage of subjects with score of 2 or 3 on Patient Satisfaction Questionnaire at week 12 of treatment.(12 weeks)
研究者
Kseniya Kobets
Assistant Professor, Department of Medicine (Dermatology)
Montefiore Medical Center