Androgenetic Alopecia, Hair Loss, Male Pattern Baldness
Conditions
Keywords
Androgenetic Alopecia, Hair Loss, Male Pattern Baldness
Brief summary
The purpose of this study is to evaluate the change in terminal hair count at 16 and 26 weeks compared to baseline measurements.
Detailed description
This is randomized, double-blind, control device clinical study across 3 sites, evaluating changes in terminal hair-count in the evaluation zone having evidence of androgenetic alopecia (miniaturized hair). The trial will involve approximately 75 male subjects who have been diagnosed with androgenetic alopecia, who are between 25 and 60 years of age, have Fitzpatrick Skin Types I-IV, with classifications of Norwood-Hamilton IIa to V, have active hair loss within the last 12 months. Subjects will use the device on three non-consecutive days a week as directed per device for 26 weeks treatment duration. Safety analysis will be assessed based on the reports of adverse events during study.
Interventions
DEVICEHairMax LaserComb
Device application 3 times week (non-consecutive days), for 26 weeks
DEVICEControl device
Device is used 3 times a week on non-consecutive days
Sponsors
Lexington International, LLC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
MALE
Age
25 Years to 60 Years
Healthy volunteers
Yes
Inclusion criteria
* Diagnosis of androgenetic alopecia * Fitzpatrick Skin Types I-IV * Norwood-Hamilton IIa to V * Active hair loss within last 12 months
Exclusion criteria
* Photosensitivity to laser light * Malignancy in the target area
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes in Terminal Hair Count at 16 and 26 Weeks Compared to Baseline in Men Diagnosed With Androgenetic Alopecia | baseline, 16 and 26 weeks | The primary analysis of effectiveness was an analysis of covariance, which separately modeled terminal hair count at Week 16 and Week 26 as a function of treatment group (HairMax LaserComb 2009 9 Beam vs.control), study center, age (as a continuous variable), and Fitzpatrick Skin Type classification (as a categorical variable with four levels). The active group was compared to the control device using least squares means with a two-sided test at the 5% level of significance. |
Countries
United States
Participant flow
Recruitment details
Male subjects who have been diagnosed with androgenetic alopicia, who are between 25 and 60 years of age, have Fitzpatrick Skin Types i-IV and Norwood Hamilton Classifications of IIa to IV and have active hair loss with the last 12 months
Pre-assignment details
Exclusion criteria: Individuals with photosensitivity to laser light, history of any malignancy in target area, has used phytotherapy (e.g. saw palmetto) with 8 weeks prior to baseline. Subjects who has chronic dermatological conditions (eczema, psoriasis, etc) of the scalp other than male pattern baldness
Participants by arm
| Arm | Count |
|---|---|
| HairMax LaserComb 2009, 12 Beam LLLT Device 2009 12 Beam, Control Device | 28 |
| HairMax LaserComb 2009 9 Beam LLLT Device 2009 9 Beam, Control Device | 25 |
| Control Device Control device emitting LED light | 26 |
| Total | 79 |
Baseline characteristics
| Characteristic | HairMax LaserComb 2009, 12 Beam | HairMax LaserComb 2009 9 Beam | Control Device | Total |
|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 28 Participants | 25 Participants | 26 Participants | 79 Participants |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 28 Participants | 25 Participants | 26 Participants | 79 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 28 | 0 / 25 | 0 / 26 |
| serious Total, serious adverse events | 0 / 28 | 0 / 25 | 0 / 26 |
Outcome results
Primary
Changes in Terminal Hair Count at 16 and 26 Weeks Compared to Baseline in Men Diagnosed With Androgenetic Alopecia
The primary analysis of effectiveness was an analysis of covariance, which separately modeled terminal hair count at Week 16 and Week 26 as a function of treatment group (HairMax LaserComb 2009 9 Beam vs.control), study center, age (as a continuous variable), and Fitzpatrick Skin Type classification (as a categorical variable with four levels). The active group was compared to the control device using least squares means with a two-sided test at the 5% level of significance.
Time frame: baseline, 16 and 26 weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| HairMax LaserComb 2009, 12 Beam | Changes in Terminal Hair Count at 16 and 26 Weeks Compared to Baseline in Men Diagnosed With Androgenetic Alopecia | Change at 16 weeks | 23.5 hairs per cm^2 | Standard Deviation 17.67 |
| HairMax LaserComb 2009, 12 Beam | Changes in Terminal Hair Count at 16 and 26 Weeks Compared to Baseline in Men Diagnosed With Androgenetic Alopecia | Change at 26 weeks | 25.7 hairs per cm^2 | Standard Deviation 16.92 |
| HairMax LaserComb 2009 9 Beam | Changes in Terminal Hair Count at 16 and 26 Weeks Compared to Baseline in Men Diagnosed With Androgenetic Alopecia | Change at 16 weeks | 20.4 hairs per cm^2 | Standard Deviation 14.52 |
| HairMax LaserComb 2009 9 Beam | Changes in Terminal Hair Count at 16 and 26 Weeks Compared to Baseline in Men Diagnosed With Androgenetic Alopecia | Change at 26 weeks | 20.9 hairs per cm^2 | Standard Deviation 14.08 |
| Control Device | Changes in Terminal Hair Count at 16 and 26 Weeks Compared to Baseline in Men Diagnosed With Androgenetic Alopecia | Change at 16 weeks | 4.4 hairs per cm^2 | Standard Deviation 8.38 |
| Control Device | Changes in Terminal Hair Count at 16 and 26 Weeks Compared to Baseline in Men Diagnosed With Androgenetic Alopecia | Change at 26 weeks | 9.4 hairs per cm^2 | Standard Deviation 12.94 |