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The purpose of this study is to evaluate the efficacy of the HairMax LaserComb 2009 9 beam model in promoting hair growth in females diagnosed with androgenetic alopecia when treatment is applied as directed.
This is a randomized double-blind, control device clinical study across 5 sites, evaluating changes in terminal hair count in the evaluation zone having evidence of androgenetic alopecia (miniaturized hair).
The trial with 60 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 assess at visit 4 (week 16).
Safety analysis will be assessed based on the reports of adverse events during study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LLT Device 2009 9 Beam | Active Comparator | HairMax LaserComb |
|
| control device | Sham Comparator | control device |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HairMax LaserComb | Device | Device application 3 times week, for 26 weeks |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in Terminal Hair Count Week 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. | Baseline, 16 weeks, 26 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Michael Jarratt, M.D. | DermaResearch, Inc. | Principal Investigator |
| Abe Marcadis, M.D. | Palm Beach Research Center | Principal Investigator |
| David Goldberg, M.D. | Hackensack, NJ | Principal Investigator |
| Neil S Sadick, MD | Sadick Research Group | Principal Investigator |
| Jose Mendez, DO | International Dermatology Research, Inc. | Principal Investigator |
| Janet Hickman, MD | The Education and Researvh Foundation | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jose Mendez, DO | Miami | Florida | 33144 | United States | ||
| Abe Marcadis, MD |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19366270 | Result | 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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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.
This double-blind, device controlled 26 week study was recruited at 6 clinical study sites. The recruitment period was from October 29, 2008 to March 2, 2009
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| ID | Title | Description |
|---|---|---|
| FG000 | HairMax LaserComb 2009 9 Beam | This arm involves the active LLLT device with 9 laser modules. The device is used 3 times a week for 12 minutes per session for full 26 duration of the study. This device was distributed to subjects in a blinded randomized manner. Subjects were evaluated at 8, 16 and 26 weeks, with hair counts performed at week 16 and 26. |
| FG001 | Control Device | This arm involves the use of an inactive control device that emits white light. The device is used 3 times a week for full 26 duration of study. This arm of the study was blinded and dispensed to subjects on a random basis.Subjects were evaluated at 8, 16 and 26 weeks, with hair counts performed at week 16 and 26. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | HairMax LaserComb 2009 9 Beam | This arm involves the active LLLT device with 9 laser modules. The device is used 3 times a week for 12 minutes per session for full length of study. This device was distributed to subjects in a blinded randomized manner |
| BG001 | 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 Week 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. | Posted | Mean | Standard Deviation | hairs per cm^2 | Baseline, 16 weeks, 26 weeks |
|
6 months
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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 | Control Device | This control device is inactive emitting white light |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| David Michaels | Lexington International, LLC | 5614170200 | 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 application 3 times week, for 26 weeks |
|
| Palm Beach |
| Florida |
| United States |
| David Goldberg, MD | Hackensack | New Jersey | United States |
| Sadick Research Group | New York | New York | 10075 | United States |
| Janet Hickman, MD | Lynchburg | Virginia | 24501 | United States |
This arm involves the use of an inactive control device that emits white light. The device is used 3 times a week for full length of study. This arm of the study was blinded and dispensed to subjects on a random basis. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
This device is the active device with 9 laser modules |
|
|
| 0 |
| 22 |
| 0 |
| 22 |
| EG001 | HairMax LaserComb 2009 9 Beam | This device is the active device with 9 laser modules | 0 | 43 | 0 | 43 |
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| D020763 |
| Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |