Androgenetic Alopecia Clinical Trial
Official title:
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.
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.
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 Both ablative and non-ablative fractionated laser treatments augment collagen deposition and cause growth factor mediated changes to skin ultrastructure.10 Non-ablative fractionated laser therapy in MPHL patients improves hair density with and without topical administration of growth factor.10 Our proposed study confers an additional mode of treatment beyond laser-only therapy by using an ablative fractionated laser to deliver minoxidil 2% solution percutaneously. Herein, the investigators seek to further optimize patient treatment by investigating a combination of these treatment modalities for management of MPHL. The investigators hypothesize that fractionated ablative 10,600nm CO2 laser treatment and laser assisted drug delivery of minoxidil 2% solution will result in increased hair growth. With this improved clinical outcome and increased treatment efficiency, patient quality of life will be enhanced and fewer at home topical treatments may be required. ;
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT02591355 -
Evaluate the Clinical Effectiveness of RegenKit Platelet-rich Plasma (PRP) in Androgenetic Alopecia Treatment
|
N/A | |
Recruiting |
NCT06239207 -
Efficacy and Safety of Exosomes Versus Platelet Rich Plasma in Patients of Androgenetic Alopecia
|
Phase 2 | |
Completed |
NCT04945226 -
A Clinical Trial to Assess Pharmacokinetic/Pharmacodynamic Profiles and Safety of IVL3001
|
Phase 1/Phase 2 | |
Completed |
NCT01548066 -
The Efficacy and Safety of Topical Valproic Acid in Preventing Hair Loss
|
Phase 2 | |
Completed |
NCT01437163 -
Treatment of Androgenetic Alopecia in Males and Females
|
N/A | |
Completed |
NCT01226459 -
Clinical Trial in Females for Female Pattern Hair Loss
|
Phase 3 | |
Recruiting |
NCT06118866 -
A Study to Assess the Efficacy and Safety of HMI-115 in Male Subjects With Androgenetic Alopecia
|
Phase 2 | |
Completed |
NCT06149221 -
Penetration-enhanced Direct DBD Non-thermal Plasma for Hair Loss
|
N/A | |
Withdrawn |
NCT04882969 -
Thulium Laser and KeraFactor for the Treatment of Androgenetic Alopecia
|
N/A | |
Completed |
NCT01231607 -
Dutasteride Versus Placebo and Finasteride in Men With Androgenetic Alopecia
|
Phase 3 | |
Completed |
NCT04446429 -
Anti-Androgen Treatment for COVID-19
|
N/A | |
Completed |
NCT02729415 -
Point-of-Care Adipose-derived Cells for Hair Growth
|
N/A | |
Completed |
NCT02279823 -
A Phase 2 Study to Evaluate the Safety and Efficacy of CB-03-01 Solution, a Comparator Solution and Vehicle Solution in Males With Androgenetic Alopecia
|
Phase 2 | |
Not yet recruiting |
NCT01227031 -
Pharmacogenomic Study of Androgenetic Alopecia
|
N/A | |
Completed |
NCT00981461 -
Treatment of Androgenetic Alopecia in Females, 9 Beam
|
N/A | |
Completed |
NCT01451021 -
A Study to Evaluate and Compare Injections of Autologous Dermal and Epidermal Cells Into the Balding Scalp of Subjects With Hair Loss
|
Phase 2 | |
Completed |
NCT00151515 -
A Study to Evaluate the Effectiveness and Safety of 5 Percent Minoxidil Foam in the Treatment of Male Pattern Hair Loss
|
Phase 3 | |
Completed |
NCT03694067 -
Androgenetic Alopecia and the JAK-STAT Pathway
|
||
Completed |
NCT03689452 -
The Effect of Platelet Rich Plasma on Non-scarring Alopecia
|
N/A | |
Completed |
NCT03753113 -
Evaluating the Topical Herbal Solution on the Treatment of Male Pattern Hair Loss and Comparison With Minoxidil 5%
|
Phase 3 |