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The overall purpose of this clinical investigation is to collect data to support a marketing application for over the counter use of the X5 HairLaser with an indication for hair growth. The goal of this protocol is to demonstrate that the intended users of the X5 HairLaser can safely and effectively perform self-use application by following written instructions.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| X5 HairLaser | Active Comparator |
| |
| X5 HairLaser Sham Device | Sham Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| X5 HairLaser | Device | Treatment consists of three, 10-15 minute, at-home treatments per week (on nonconcurrent days) for 26 weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Difference in terminal hair count in the target region | A circular haircount target area approximately 1.9 cm in diameter will be identified between 10 and 2 o'clock in the leading edge of an actively balding area of the vertex. The target area will be clipped short (approximately 1 mm in length). A small dot tattoo will be placed in the center of the target area and will be used as a reference point. The same circular haircount area will be clipped and photographed at subsequent study visits. All hairs >30 μM will be classified as terminal hairs. The number of terminal hair counts (n/cm2) and width of terminal hairs (μM/cm2) in the hair count area will be measured at the baseline, subsequent study visits and at 26 weeks. | 26 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Subject's static self global assessment of hair regrowth | Subject will report on the following questions, on the following scale: Not at all, Slight Improvement, Moderate Improvement, Good Improvement, Greatly Improved Has your rate of hair loss slowed down? Do your believe your hair is growing faster? Does your hair feel thicker or fuller? How would you rate the overall improvement of your hair? The following question will use this scale: No growth, Minimal Growth, Moderate Growth, Dense Growth How would you rate your overall hair regrowth? |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Burke Pharmaceutical Research | Hot Springs | Arkansas | 71913 | United States | ||
| Hilltop Research |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24559020 | Derived | Blum K, Han D, Madigan MA, Lohmann R, Braverman ER. "Cold" X5 Hairlaser used to treat male androgenic alopecia and hair growth: an uncontrolled pilot study. BMC Res Notes. 2014 Feb 24;7:103. doi: 10.1186/1756-0500-7-103. |
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| X5 Hair Laser Sham Device | Device | Treatment consists of three, 10-15 minute, at-home treatments per week (on nonconcurrent days) for 26 weeks. |
|
| 26 weeks |
| St. Petersburg |
| Florida |
| 33710 |
| United States |
| NYU School of Medicine | New York | New York | 10003 | United States |
| ID | Term |
|---|---|
| D000505 | Alopecia |
| ID | Term |
|---|---|
| D007039 | Hypotrichosis |
| D006201 | Hair Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
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