The Safety and Efficacy of Fractional Ablative 10, 600nm CO2 Laser-assisted Treatments for Male Pattern Hair Loss: a Randomized Cohort Study Comparing Stand-alone Laser Treatment, Laser Assisted Drug Delivery of Minoxidil 2% Solution , and Laser Assisted Drug Delivery of Minoxidil 2% Solution Plus Self-administration of Minoxidil 5% at Home.
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Hair Growth Assessment (HGA)
研究概览
简要总结
The objective of this study is to evaluate the safety and efficacy of fractionated ablative 10,600nm CO2 laser assisted delivery of 2% minoxidil solution in the treatment of MPHL. In this cohort study, patients will randomly be assigned stand-alone laser treatment, laser assisted drug delivery of minoxidil 2% solution, and laser assisted drug delivery of minoxidil 2% solution plus at home 5% minoxidil treatment. The primary endpoints will be to assess the change from baseline in investigator and subject Hair Growth Assessments (HGA), Hair Growth Index (HGI) and the Hair Growth Satisfaction Scale (HGSS) over 8-12 weeks in each of the three groups. The secondary endpoints will be expert assessment of hair density from baseline and evaluation of safety and adverse events, and pharmacokinetic (PK) data.
详细描述
Male pattern hair loss (MPHL) is a common, frustrating, and difficult to manage scalp disease with few treatment options available. Though the mechanism remains unclear, minoxidil is a well-established treatment for MPHL. With the advent of laser assisted drug delivery, the investigators seek to investigate the use of laser assisted minoxidil delivery to improve bioavailability, and subsequent hair growth for subjects MPHL. With an improved clinical outcome and increased treatment efficiency, patient quality of life would be enhanced and fewer at home topical treatments with minoxidil may be required. Additionally, this study will assist in understanding the effects of stand-alone laser therapy on hair growth and may also be used as a background or framework for a growing number of studies investigating this technology as a drug delivery system.
MPHL, also known as androgenetic alopecia, is a non-scarring alopecia resulting in gradual hair loss localized to the scalp. In men, this progressive hair loss disorder results in characteristic thinning of hair over the vertex and frontal regions.1 The Hamilton-Norwood scale categorizes this typical clinical progression.2 While the pathogenesis of MPHL is not entirely elucidated, it has been proposed to be an age and hormone dependent process with dihydrotestosterone playing a significant role.2,3 Genetic factors may also contribute to the disease.4
Topical minoxidil is an FDA approved treatment for MPHL. Minoxidil 2 and 5% solution are known to increase hair regrowth in men with androgenetic alopecia.7 While the mechanism remains unknown, it has been proposed minoxidil increases the duration of anagen and vascular supply to the follicular structure.8
Topical treatments for MPHL such as minoxidil have limited efficacy, as topical delivery of medication has low bioavailability.9 With the advent of fractionated ablative and non-ablative laser technologies, more efficient drug delivery to the level of the superficial epidermis and dermis is now possible.
The outermost layer of skin, the stratum corneum, impedes the diffusion of topical medications to follicular structures in the dermis and hypodermis. 9 Ablative fractionated laser devices create vertical channels, permitting topical medication to breach the skin's top layer, the stratum corneum, and reach deep skin layers where hair follicles reside.9
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 (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 21 Years 至 65 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Males ages 21-65 years old with MPHL
- •Norwood III vertex-V. The vertex scalp must be involved
- •MPHL diagnosed by a board-certified dermatologist
- •Willing to abstain from use of over the counter products and prescription products other than those supplied in the study
- •Willing to abstain from the use of non-steroidal anti-inflammatory medications, aspirin, St. Johns Wart, and high doses of Vitamin E supplementation
- •Subjects must be capable of giving informed consent
- •Willing to adhere to protocol, including scalp examinations and photography
排除标准
- •Allergy or intolerance to minoxidil
- •Underlying disease that might be adversely affected by minoxidil.
- •Immunosuppressed patients (history of transplantation, cancer, chemotherapy, splenectomy, HIV)
- •Application of topical immunomodulatory or immunosuppressive agent in the preceding 6 weeks
- •Systemic administration of corticosteroid or other systemic treatment (e.g. prednisone) that has immunomodulatory or other immunosuppressive mechanism of action, in the preceding 8 weeks or planned usage at any time throughout the study
- •Clinical evidence of secondary skin infection (e.g. folliculitis)
- •Other inflammatory or infectious skin disease that might interfere with evaluations during the study
- •Investigational medications within the past 30 days
- •Severe allergies manifested by a history of anaphylaxis, or history or presence of multiple severe allergies
- •Oral retinoids within the past 6 months and topical retinoid usage within the past 4 weeks
- •Patients with history of or susceptible to keloid formation
- •Finasteride or dutasteride within the past 6 weeks
- •Spironolactone within the past 6 weeks
- •Active infection
- •Lesions in the treated area suspicious for malignancy
- •Known allergy to hair dye or hair dye components
- •Relevant history of hypotension
- •Hypertension that is untreated or uncontrolled
- •Radiation or chemotherapy to the site
- •Use of topical or oral ketoconazole in the past 6 weeks
- •Hair transplants or weaves
- •Other concomitant types of history of hair loss such as telogen effluvium
- •Medical problems including HIV, connective tissue disorder, PCOS, untreated thyroid disease
- •Psychiatric disease that that may increase risks within the trial
- •Current use of tanning beds or any active tanning
- •Use of antihypertensives or vasodilators following a first-time diagnosis of hypertension within the past 6 months
- •Planned upcoming surgeries
- •Tattoo on scalp
- •Use of oral minoxidil within the past 6 months
- •History of orthostatic hypotension
- •Adults lacking capacity to consent
- •Adults who do not speak English.
- •A medical history or clinical evidence of: acute myocardial infarction, angina, cardiac disease, cardiac tamponade, cerebrovascular disease, coronary artery disease, hypotension, orthostatic hypotension, pericardial effusion, peripheral edema, heart failure, pulmonary hypertension, renal disease, renal failure, renal impairment, pregnancy, breast-feeding, children, pheochromocytoma, skin abrasion, and geriatric.
研究组 & 干预措施
Safety Group
will participate in one visit, receiving laser assisted delivery of minoxidil and PK data. The safety group treatments will follow dose escalation as follows:
- Safety Participant 1: Post-laser 5mg minoxidil (0.25ml of 20mg/ml sterile solution, applied post-laser procedure)
- Safety Participant 2: Post-laser 10mg minoxidil (0.5ml of 20mg/ml sterile solution, applied post-laser procedure)
- Safety Participant 3: Post-laser 20mg minoxidil (1mL of 20mg/mL sterile solution, applied post-laser procedure)
干预措施: Laser (Device)
Safety Group
will participate in one visit, receiving laser assisted delivery of minoxidil and PK data. The safety group treatments will follow dose escalation as follows:
- Safety Participant 1: Post-laser 5mg minoxidil (0.25ml of 20mg/ml sterile solution, applied post-laser procedure)
- Safety Participant 2: Post-laser 10mg minoxidil (0.5ml of 20mg/ml sterile solution, applied post-laser procedure)
- Safety Participant 3: Post-laser 20mg minoxidil (1mL of 20mg/mL sterile solution, applied post-laser procedure)
干预措施: Post-laser 5mg minoxidil (Drug)
Safety Group
will participate in one visit, receiving laser assisted delivery of minoxidil and PK data. The safety group treatments will follow dose escalation as follows:
- Safety Participant 1: Post-laser 5mg minoxidil (0.25ml of 20mg/ml sterile solution, applied post-laser procedure)
- Safety Participant 2: Post-laser 10mg minoxidil (0.5ml of 20mg/ml sterile solution, applied post-laser procedure)
- Safety Participant 3: Post-laser 20mg minoxidil (1mL of 20mg/mL sterile solution, applied post-laser procedure)
干预措施: Post-laser 10mg minoxidil (Drug)
Safety Group
will participate in one visit, receiving laser assisted delivery of minoxidil and PK data. The safety group treatments will follow dose escalation as follows:
- Safety Participant 1: Post-laser 5mg minoxidil (0.25ml of 20mg/ml sterile solution, applied post-laser procedure)
- Safety Participant 2: Post-laser 10mg minoxidil (0.5ml of 20mg/ml sterile solution, applied post-laser procedure)
- Safety Participant 3: Post-laser 20mg minoxidil (1mL of 20mg/mL sterile solution, applied post-laser procedure)
干预措施: Post-laser 20mg minoxidil (Drug)
Placebo
Laser: Fractional ablative, deep mode, 5% fractional coverage
Post-Laser Saline 0.9%: 2ml of sterile saline solution applied post-laser procedure
干预措施: Laser (Device)
Treatment A
Laser: Fractional ablative, deep mode, 5% fractional coverage
Post-Laser Minoxidil 2%: 2ml of 20mg/ml sterile solution, applied post-laser procedure
干预措施: Post-Laser Minoxidil 2% (Drug)
Treatment B
Laser: Fractional ablative, deep mode, 5% fractional coverage
Post-Laser Minoxidil 2%: 2ml of 20mg/ml sterile solution, applied post-laser procedure
At-Home Minoxidil 5%: 2ml of 50mg/ml foam q24 h for duration of study
干预措施: Post-Laser Minoxidil 2% (Drug)
Treatment B
Laser: Fractional ablative, deep mode, 5% fractional coverage
Post-Laser Minoxidil 2%: 2ml of 20mg/ml sterile solution, applied post-laser procedure
At-Home Minoxidil 5%: 2ml of 50mg/ml foam q24 h for duration of study
干预措施: At-Home Minoxidil 5% (Drug)
结局指标
主要结局
Hair Growth Assessment (HGA)
时间窗: End of trial (8-16 weeks)
Scale indicating graded degree of change represented as no change, worse outcome, better outcome.
Hair Growth Index (HGI)
时间窗: End of trial (8-16 weeks)
Hair growth is compared from baseline by three self-report questions on a health outcome questionnaire
Change in Hair Growth Satisfaction Scale (HGSS)
时间窗: Week 0, Week 4(+4), Week 8(+4)
Hair appearance/growth is compared from baseline by five self-report questions that rank satisfaction with hair growth on a scale from -3 (very dissatisfied) to 3 (very satisfied).
Change in Investigator Global Assessment of Photography
时间窗: Week 0, end of trial (8-16 weeks)
Scale from -3 (significant worsening) to 3 (significant improvement) assessing hair loss/growth
次要结局
- Change in Additional Investigator Global Assessment of Photography(Week 0, end of trial (8-16 weeks))
- Change in Scalp Symptom Assessments(Week 0, Week 4(+4), Week 8(+4))