Androgenetic Alopecia, Female Pattern Baldness, Hair Loss
Conditions
Keywords
Androgenetic Alopecia, Hair Loss, Female Pattern Baldness
Brief summary
The purpose of this study is to evaluate the efficacy of the HairMax LaserComb 2009 12 beam model for androgenetic alopecia in females when treatment is applied as directed.
Detailed description
This is a randomized double-blind, sham controlled clinical study, evaluating changes in terminal hair count in the evaluation zone having evidence of androgenetic alopecia (miniaturized hair). The trial with 63 female 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 Ludwig I-4, II-1, II-2, or frontal, have active hair loss within the last 12 months. Subjects will use the device on three non-concurring days a week as directed per device for 26 weeks duration. Initial efficacy endpoint for each subject will be assessed at visit 4 (week 16). Safety analysis will be assessed based on the reports of adverse events during study.
Interventions
DEVICEHairMax LaserComb 2009 model 12 beam
HairMax LaserComb
DEVICESham Device
Sham Device
Sponsors
Lexington International, LLC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
25 Years to 60 Years
Healthy volunteers
Yes
Inclusion criteria
* Diagnosis of androgenetic alopecia * Fitzpatrick Skin types I-IV * Ludwig I-4, II-1, II-2, or frontal * Active hair loss within last 12 months
Exclusion criteria
* Photosensitivity to laser light * Malignancy in the target area * Pregnancy * Lactating females
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Hair Count at 16 and 26 Weeks Over Baseline | Baseline, 16 weeks, 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
This double-blind, device controlled 26 week study was recruited at 3 clinical study sites. The recruitment period was from February 1, 2010 to September 28, 2010
Pre-assignment details
Key exclusion criteria was pregnancy, malignancy in target area, an no hair transplants, scalp reductions, or hair weaves. Active hair loss less than 12 months.
Participants by arm
| Arm | Count |
|---|---|
| Sham Device Sham device | 21 |
| LLT Device 2009 12 Beams HairMax LaserComb 2009 model 12 beam | 42 |
| Total | 63 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 3 | 3 |
Baseline characteristics
| Characteristic | Sham Device | LLT Device 2009 12 Beams | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 21 Participants | 42 Participants | 63 Participants |
| Sex: Female, Male Female | 21 Participants | 42 Participants | 63 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 18 | 0 / 39 |
| serious Total, serious adverse events | 0 / 18 | 0 / 39 |
Outcome results
Primary
Change in Hair Count at 16 and 26 Weeks Over Baseline
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 weeks, 26 weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Sham Device | Change in Hair Count at 16 and 26 Weeks Over Baseline | Change at 16 weeks | -0.8 hairs per cm^2 | Standard Deviation 7.87 |
| Sham Device | Change in Hair Count at 16 and 26 Weeks Over Baseline | Change at 26 weeks | 3.0 hairs per cm^2 | Standard Deviation 9.33 |
| LLT Device 2009 12 Beams | Change in Hair Count at 16 and 26 Weeks Over Baseline | Change at 16 weeks | 12.5 hairs per cm^2 | Standard Deviation 11.35 |
| LLT Device 2009 12 Beams | Change in Hair Count at 16 and 26 Weeks Over Baseline | Change at 26 weeks | 20.6 hairs per cm^2 | Standard Deviation 11.55 |