Clinical Trial Details
— Status: Withdrawn
Administrative data
NCT number |
NCT03852992 |
Other study ID # |
DERM-2018-27024 |
Secondary ID |
|
Status |
Withdrawn |
Phase |
Phase 2
|
First received |
|
Last updated |
|
Start date |
September 30, 2022 |
Est. completion date |
July 1, 2023 |
Study information
Verified date |
September 2023 |
Source |
University of Minnesota |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial Summary
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.
Description:
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.