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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HairMax LaserComb 2009, 7 Beam | Active Comparator | Lower level laser phototherapy medical device with 7 laser beams |
|
| Control Device | Active Comparator | Identical to the Active device, but with 7 LED's instead of lasers |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HairMax LaserComb 2009, 7 Beam | 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 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 | 16 and 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 |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Abe Marcadis, M.D. | Palm Beach | Florida | 33409 | United States | ||
| Michael Jarratt, MD |
| 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, 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
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
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| ID | Title | Description |
|---|---|---|
| FG000 | LLT Device 2009 7 Beam | |
| FG001 | Control Device |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | LLT Device 2009 7 Beam | |
| BG001 | Control Device | |
| BG002 | Total |
| 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 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 | Posted | Mean | Standard Deviation | change in terminal hair count | 16 and 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 | LLT Device 2009 7 Beam |
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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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| HairMax LaserComb | Device | Device application 3 times week (non-consecutive days), for 26 weeks |
|
|
| Austin |
| Texas |
| 78759 |
| United States |
Total of all reporting groups
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| 0 |
| 24 |
| 0 |
| 0 |
| EG001 | Control Device | 0 | 14 | 0 | 0 |
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| D020763 |
| Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |