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 efficacy of the HairMax LaserComb 2009 7 Beam model in promoting hair growth in males diagnosed with androgenetic alopecia when treatment is applied as directed.
Detailed description
This is randomized, double-blind, control device clinical study across 2 sites, evaluating changes in terminal hair-count in the evaluation zone having evidence of androgenetic alopecia (miniaturized hair). The trial will involve 45 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 nonconcurring days a week as directed per device for 26 weeks treatment 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, 7 Beam
Device application 3 times week (non-consecutive days), for 26 weeks
DEVICEHairMax LaserComb
Device application 3 times week (non-consecutive days), for 26 weeks
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 Over Baseline | 16 and 26 weeks | Results of terminal hair count will be compared to baseline for each user between active and control devicea at 26 weeks with an interim evaluation at week 16. Terminal hair count, which is non-vellus/non-miniaturized hair counts, will be assessed in the target region |
Countries
United States
Participant flow
Recruitment details
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 Norwood Hamilton Classifications of IIa-V, have active hair loss with the last 12 months
Pre-assignment details
Exclusion Criteria: Individuals with photosensitivity to laser light, histor of any malignancy in target area. Also, use of phytotherapy (e.g. saw palmetto) within 8 weeks prior to baseline and use of retinoids in past year, chronic dermatological condtion (eczema , psoriasis, infection, etc.) of the scalp other than male pattern baldness
Participants by arm
| Arm | Count |
|---|---|
| LLT Device 2009 7 Beam | 33 |
| Control Device | 16 |
| Total | 49 |
Baseline characteristics
| Characteristic | LLT Device 2009 7 Beam | Control Device | 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 | 33 Participants | 16 Participants | 49 Participants |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 33 Participants | 16 Participants | 49 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 24 | 0 / 14 |
Outcome results
Primary
Changes in Terminal Hair Count at 16 and 26 Weeks Over Baseline
Results of terminal hair count will be compared to baseline for each user between active and control devicea at 26 weeks with an interim evaluation at week 16. Terminal hair count, which is non-vellus/non-miniaturized hair counts, will be assessed in the target region
Time frame: 16 and 26 weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| LLT Device 2009 7 Beam | Changes in Terminal Hair Count at 16 and 26 Weeks Over Baseline | Change at 16 weeks | 17.7 change in terminal hair count | Standard Deviation 12.83 |
| LLT Device 2009 7 Beam | Changes in Terminal Hair Count at 16 and 26 Weeks Over Baseline | Change at 26 weeks | 18.4 change in terminal hair count | Standard Deviation 16.6 |
| Control Device | Changes in Terminal Hair Count at 16 and 26 Weeks Over Baseline | Change at 16 weeks | 2.8 change in terminal hair count | Standard Deviation 6.89 |
| Control Device | Changes in Terminal Hair Count at 16 and 26 Weeks Over Baseline | Change at 26 weeks | 1.6 change in terminal hair count | Standard Deviation 8.6 |