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Photobiomodulation is a form of non-ionizing light therapy has been shown to stimulate cellular processes and reduce inflammation as well as improve pain and wound healing. Photobiomodulation has also been found to enhance fibroblast growth factor production. A challenge in clinic is to answer the patients' questions regarding which FDA-cleared device is the best to purchase. Therefore, this study was designed to gain experience with the use of the following devices and to clinically evaluate their efficacy: iGrow Hair Growth System, Capillus352, Hair Max Ultima 12 LaserComb, and HairMax Laserband 82. The purpose of this pilot research study is to clinically compare and evaluate FDA-cleared photobiomodulation devices after four months of treatment and one-month follow-up in subjects with alopecia.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| iGrow Hair Growth System | Experimental | male or female subjects ages 21-85 with alopecia randomized to use iGrow Hair Growth System photobiomodulation device. |
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| Capillus352 | Active Comparator | male or female subjects ages 21-85 with alopecia randomized to use Capillus352 photobiomodulation device. |
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| HairMax Ultima 12 Lasercomb | Experimental | male or female subjects ages 21-85 with alopecia randomized to use HairMax Ultima 12 Lasercomb photobiomodulation device. |
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| HairMax Laserband 82 | Experimental | male or female subjects ages 21-85 with alopecia randomized to use HairMax Laserband 82 photobiomodulation device. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| iGrow Hair Growth System | Device | has a helmet-design and headphones to allow for hands-free use and music listening capabilities. Treatment is 25 minutes every other day. three to four times per week for 4 months. |
| Measure | Description | Time Frame |
|---|---|---|
| Investigator's Global Assessment Score (IGA score) | Units on a scale. Standardized rating system used in research to assess various dermatologic conditions, including hair loss (-3-+3). It involves visual examination by trained board-certified dermatologists to evaluate specific criteria assessing the overall severity of hair loss. | baseline to 5 months |
| Savin score | Units on a scale. Classification systems for female pattern hair loss (I-1-III) severity, assessed during monthly examinations. | baseline to 5 months |
| Ludwig score | Units on a scale. Classification system for female pattern hair loss (I-III) severity, assessed during monthly examinations. | baseline to 5 months |
| Hamilton-Norwood score | Units on a scale. Classification systems for male pattern hair loss (I-VII) severity, assessed during monthly examinations. | Baseline to 5 months |
| Dermatologist Evaluation of Scalp Health (Scale) | Scalp health, specifically scale, is evaluated and marked as "absent", "mild", or "moderate" by a board-certified dermatologist during monthly examinations. | Baseline to 5 months |
| Dermatologist Evaluation of Scalp Health (Erythema) | Dermatologist Evaluation of Scalp Health (Erythema) Description: Scalp health, specifically erythema, is evaluated and marked as "absent", "mild", or "moderate" by a board-certified dermatologist during monthly examinations. | Baseline to 5 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Maria K Hordinsky, MD | University of Minnesota | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Minnesota | Minneapolis | Minnesota | 55455 | 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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| Capillus352 | Device | has a similar design to a salon hair dryer which hovers over the head to allow for hand-free use. Treatment is 12 minutes, three times per week for 4 months. |
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| HairMax Ultima 12 Lasercomb | Device | is comb-like device with hair-parting teeth to aid in delivery of light therapy directly to the scalp. Treatment is 8 minutes three times per week for 4 months. |
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| HairMax Laserband 82 | Device | is headband design device which has unique hair-parting teeth to aid in delivery of light therapy directly to the scalp. Treatment is 90-second treatments three times per week for 4 months. |
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| Dermatologist Evaluation of Scalp Health (Folliculitis) | Scalp health, specifically folliculitis, is evaluated and marked as "absent", "mild", or "moderate" by a board-certified dermatologist during monthly examinations. | Baseline to 5 months |
| Hair Growth Assessment (HGA) | Units on a scale. A scale used to describe scalp hair growth progress compared to baseline photos. Change is quantified on a scale of -3 to 3. | Baseline to 5 months |
| Hair Growth Index (HGI) | Units on a scale. Hair growth is evaluated using three self-assessment questions on a scale of -3 to 3. | Baseline to 5 months |
| Hair Growth Satisfaction Surveys (HGSS) | Units on a scale. Participant satisfaction with hair appearance/growth compared to baseline across five questions on a scale of -3 to 3. | Baseline to 5 months |
| Subject Scalp Health Assessment (SSHA) | Units on a scale. Self-assessment of scalp health and hair condition through multiple questions measured on a scale of -2 to 2 during monthly exams. | Baseline to 5 months |
| D020763 |
| Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |