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The purpose of this study is to evaluate the efficacy of Low Level Laser and Light Therapy system configured in a novel product called the TopHat 655 system, for promoting hair growth in males and females diagnosed with androgenetic alopecia of the head.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Red Incandescent light source | Sham Comparator |
| |
| TopHat 655 | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TopHat 655 rejuvenation system | Device | TopHat 655 system is to be applied every other day for 16 weeks for a pre-programmed time period |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage Increase of Terminal Hairs from Pre-treatment, Baseline Count | After 16 weeks of therapy |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Raymond J. Lanzafame, MD | Raymond J. Lanzafame, MD | Study Director |
| Peter S. Halperin, MD | Peter S. Halperin, MD | Principal Investigator |
| Adolfo Fernandez-Obregon, MD | Adolfo Fernandez-Obregon, MD | Principal Investigator |
| Jeffrey A Sklar, MD | Center for Aesthetic Dermatology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Adolfo Fernandez-Obregon, MD | Hoboken | New Jersey | 07030 | United States | ||
| Peter S. Halperin, MD |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25124964 | Derived | Lanzafame RJ, Blanche RR, Chiacchierini RP, Kazmirek ER, Sklar JA. The growth of human scalp hair in females using visible red light laser and LED sources. Lasers Surg Med. 2014 Oct;46(8):601-7. doi: 10.1002/lsm.22277. Epub 2014 Aug 13. | |
| 24078483 | Derived | Lanzafame RJ, Blanche RR, Bodian AB, Chiacchierini RP, Fernandez-Obregon A, Kazmirek ER. The growth of human scalp hair mediated by visible red light laser and LED sources in males. Lasers Surg Med. 2013 Oct;45(8):487-95. doi: 10.1002/lsm.22173. |
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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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| Laser and/or Light Hair Rejuvenation System | Device | A red incandescent light source replaces all lasers and light emitting diodes. |
|
| New York |
| New York |
| 10065 |
| United States |
| Raymond J. Lanzafame, MD | Rochester | New York | 14617 | United States |
| Jeffrey A. Sklar, MD | Woodbury | New York | 11797 | United States |
| D020763 |
| Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |