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The purpose of this study is to evaluate the change in terminal hair count at 16 and 26 weeks compared to baseline measurements.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HairMax LaserComb 2009, 12 Beam | Active Comparator | Low Level Laser Medical Device 2009 with 12 laser beams |
|
| HairMax LaserComb 2009 9 Beam | Active Comparator | Low Level Laser Mecial Device 2009 with 9 laser beams |
|
| Control device | Active Comparator | The control device appears identical to the active device, but utilizes 9 LED lights instead of laser lights. The randomized devices are blinded to the study investigator and distributed in a blinded manner to the participants. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HairMax LaserComb | Device | Device application 3 times week (non-consecutive days), for 26 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | baseline, 16 and 26 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Zoe Draelos, MD | High Point, NC | Principal Investigator |
| David Goldberg, M.D. | Skin & Laser | Principal Investigator |
| Abe Marcadis, M.D. | Palm Beach Research | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Abe Marcadis, M.D. | West Palm Beach | Florida | 33409 | United States | ||
| David Goldberg, M.D. |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19366270 | Background | Leavitt M, Charles G, Heyman E, Michaels D. HairMax LaserComb laser phototherapy device in the treatment of male androgenetic alopecia: A randomized, double-blind, sham device-controlled, multicentre trial. Clin Drug Investig. 2009;29(5):283-92. doi: 10.2165/00044011-200929050-00001. |
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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
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
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| ID | Title | Description |
|---|---|---|
| FG000 | HairMax LaserComb 2009, 12 Beam | LLLT Device 2009 12 Beam, Control Device |
| FG001 | HairMax LaserComb 2009 9 Beam | LLLT Device 2009 9 Beam, Control Device |
| FG002 | Control Device | Control device emitting LED light |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | HairMax LaserComb 2009, 12 Beam | LLLT Device 2009 12 Beam, Control Device |
| BG001 | HairMax LaserComb 2009 9 Beam | LLLT Device 2009 9 Beam, Control Device |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Mean | Standard Deviation | hairs per cm^2 | baseline, 16 and 26 weeks | hairs per cm^2 | Participants |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | HairMax LaserComb 2009, 12 Beam | LLLT Device 2009 12 Beam, Control Device |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| David Michaels | Lexington International, LLC | 561-417-0200 | dm@hairmax.com |
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| ID | Term |
|---|---|
| D000505 | Alopecia |
| ID | Term |
|---|---|
| D007039 | Hypotrichosis |
| D006201 | Hair Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| Control device | Device | Device is used 3 times a week on non-consecutive days |
|
| Hackensack |
| New Jersey |
| 07601 |
| United States |
| Zoe Draelos, M.D. | High Point | North Carolina | 27262 | United States |
| BG002 | Control Device | Control device emitting LED light |
| BG003 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| HairMax LaserComb 2009 9 Beam |
the active LLLT Device 2009 9 laser modules |
| OG002 | Control Device | Control device emitting white light |
|
|
| 0 |
| 28 |
| 0 |
| 28 |
| EG001 | HairMax LaserComb 2009 9 Beam | LLLT Device 2009 9 Beam, Control Device | 0 | 25 | 0 | 25 |
| EG002 | Control Device | Control device emitting LED light | 0 | 26 | 0 | 26 |
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| D020763 |
| Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |