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This is a prospective, randomized double-blind, multi-center study to evaluate the efficacy of low level laser therapy over-the-counter at home device Theradome LH80 PRO, compared to SHAM for promoting hair growth in males diagnosed with androgenetic alopecia, and a usability study to assess subject ability to self-assess hair loss and understanding use of the device.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LH80 PRO | Active Comparator | Low level laser therapy |
|
| Sham device | Sham Comparator | No low level laser therapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LH80 PRO | Device |
| ||
| Sham Device |
| Measure | Description | Time Frame |
|---|---|---|
| Hair growth | Determination of hair growth vs baseline through global photographic review by a blinded reviewer(s). | 26 weeks |
| Quantitative Hair Growth | Change from baseline in non-vellus Terminal Hair count (≥ 30 μm) as measured with macrophotography (aka trichogram). | 26 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Subject Self Assessment | Determination of subject ability to self-assess hair loss and correctly use the device via direct observation and use of diary. | 26 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Axis Clinical Tirals | Los Angeles | California | 90036 | United States | ||
| MedaPhase, Inc. |
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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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|
| Newnan |
| Georgia |
| 30263 |
| United States |
| NW Dermatology & Research Center, LLC | Portland | Oregon | 97210 | United States |
| Tennessee Clinical Research Center | Nashville | Tennessee | 37215 | United States |
| D020763 |
| Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |