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The goal of this clinical study is to evaluate the efficacy and safety of the Ultra device for the treatment of hair regrowth by assessing the improvement of hair density and hair shaft diameter.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ultra Treatment | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Low Level Laser Therapy | Device | Study participants received a total of 6 low level laser therapy treatments on their scalp. The treatments occurred 2 weeks apart (+/- 3 days). |
|
| Measure | Description | Time Frame |
|---|---|---|
| Difference in the Change in Hair Density from Baseline vs 90-day Follow-up | To evaluate the difference in the change in hair density at baseline vs 90 day follow up in a pre-determined measurement point in the treatment area as measured with a professional dermascope. | From baseline (treatment 1) to the 90 day follow up after treatment 6. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Charlotte Antoni Clinical Research Coordinator | Contact | 9786276614 | charlotte.antoni@cynosurelutronic.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dy Dermatology | Recruiting | Glenview | Illinois | 60025 | United States |
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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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| ID | Term |
|---|---|
| D028022 | Low-Level Light Therapy |
| ID | Term |
|---|---|
| D053685 | Laser Therapy |
| D013812 | Therapeutics |
| D010789 | Phototherapy |
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| Cynosure Lutronic | Recruiting | Westford | Massachusetts | 01886 | United States |
|
| D020763 |
| Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |