Modulated Light Therapy in Participants With Pattern Hair Loss

Inclusion Criteria

• The study population will consist of adult men and women between 18 and 65 years of age with diagnosis of Androgenic Alopecia, consistent with males who have Norwood Hamilton Classification IIa to V patterns of hair loss and females who have Ludwig-Savin Scale I-1 to I-4, II -1, II-2 or frontal, both with Fitzpatrick Skin Types I - IV. Participants agree to undergo all study procedures including global photographs of hair loss/growth, placement of a 1 mm tattoo dot placed on the scalp for macrophotography, refrain from using all other hair growth products or treatments (oral or topical medication including over the counter herbal medications, or Dutasteride), avoid the use of wigs, hairpieces, and/or hair extensions during the study, return for all the required follow-up visits, and in the opinion of the Clinical Investigator, are able to understand this clinical investigation and cooperate with the investigational procedures.

Candidates for this study must meet ALL of the following criteria:

• Male and Female participants between 18 and 65 years of age
• Must be able to read and speak English.
• Participants who are able to give voluntary, written informed consent to participate in this clinical investigation and from whom consent has been obtained.
• Participants, who, in the opinion of the Clinical Investigator, are able to understand this clinical investigation, cooperate with the investigational procedures and are willing to return for all the required follow-up visits.
• Participant must be able to visit clinic site at 8-, 16- and 26-weeks study visits and be available by phone at 4 weeks.
• Participant must have the ability to communicate effectively with study personnel in person or over the phone.
• Participant must have diagnosis of Androgenic Alopecia (pattern hair loss).
• Participant must have active hair loss consistent with Grades IIa to V, based on Norwood- Hamilton Scale or Ludwig-Savin Scale I-1 to I-4, II -1, II-2 or frontal and Grades I - IV using Fitzpatrick Skin Type Scale.
• Participant's hair must be at least 1 inch in length. The hair style and length shall be the same for each follow-up visit. Participants will be instructed to not have their hair cut/styled within 5 days prior to a follow-up visit.
• Participant is willing to have a dot tattoo placed on or around the target area of the scalp.
• Participant is willing to undergo all study procedures including consent for global photographs of hair loss/growth and a 1 mm tattoo to mark the macrophotography site along the indicated transition area of the scalp between the hairline and the balding/thinning vertex area.
• Participant is willing to avoid the use of wigs, hairpieces, and/or hair extensions during the study period.
• Hair Specific Skindex-29 Quality of Life total overall score of ≥ 45.
• Participant is willing to maintain their natural hair colour or including the use of coloring throughout the study period.
• Participant agrees to refrain from using all other hair growth products or treatments (oral or topical medication including over the counter herbal medications, or Dutasteride) during the study period.
• Participant has the ability to utilize a Bluetooth device and application on a smart device connected to Wi-Fi.

Exclusion Criteria

• Participants with 12 month history of taking Propecia or any other hair growth supplements including Rogaine or Minoxidil based products for 6-months prior to enrollment, having previous hair transplant, cell treatment, micro-needling, tattooing, or any other treatment to the scalp, suffering from an active autoimmune disease such as serum lupus erythematosus or alopecia areata, photosensitivity to visible light, currently suffering from a dermatological condition in the treatment area or has a significant scar in the hair treatment area that will make hair growth difficult (such as a systemic burn, malignancy, etc.), has a sensitivity or allergy to tatto