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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sham Device | Sham Comparator | Sham device |
|
| LLT Device 2009 12 Beams | Active Comparator | HairMax LaserComb 2009 model 12 beam |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HairMax LaserComb 2009 model 12 beam | Device | HairMax LaserComb |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline, 16 weeks, 26 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Maria Hordinsky, M.D. | University of Minnesota | Principal Investigator |
| Wilma Bergfeld, M.D. | The Cleveland Clinic | Principal Investigator |
| Lawrence Schachner, M.D. | University of Miami | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Miami Miller School of Medicine - Dermatology | Miami | Florida | 33136 | United States | ||
| University of Minnesota, Department of Dermatology |
| 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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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 3 clinical study sites. The recruitment period was from February 1, 2010 to September 28, 2010
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| ID | Title | Description |
|---|---|---|
| FG000 | Sham Device | Sham device |
| FG001 | LLT Device 2009 12 Beams | HairMax LaserComb 2009 model 12 beam |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Sham Device | Sham device |
| BG001 | LLT Device 2009 12 Beams | HairMax LaserComb 2009 model 12 beam |
| 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 | 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. | Posted | Mean | Standard Deviation | hairs per cm^2 | Baseline, 16 weeks, 26 weeks |
|
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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 | Sham Device | Sham device |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| David Michaels | Lexington International, LLC | 5614170200 | las@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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| Sham Device |
| Device |
Sham Device |
|
| Minneapolis |
| Minnesota |
| 55455 |
| United States |
| Cleveland Clinic Foundation - Department of Dermatology | Cleveland | Ohio | 44195 | United States |
| BG002 |
| Total |
Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
This is the active LLLT device
|
|
| 0 |
| 18 |
| 0 |
| 18 |
| EG001 | LLT Device 2009 12 Beams | HairMax LaserComb 2009 model 12 beam | 0 | 39 | 0 | 39 |
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| D020763 |
| Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |