Assessing the Safety and Efficacy of a Novel Microneedling and Laser Device for Male Pattern Hair Loss

Exclusion Criteria

• •Subjects who have used any formulation or application/administration or type of treatment for disorders of the skin or scalp within 180 days prior to screening, including but not limited to the following treatments:
• •1. Anti-inflammatory medications, including topical steroids
• •2. Antifungal
• •3. Skin, nail, hair rejuvenation supplementation, or IV infusions (includes vitamin, minerals, herbals, etc.)
• •4. Hair growth shampoos, conditioners, and topicals
• •5. Topical, dermal or oral minoxidil, finasteride, or dutasteride
• •6. Hair growth stimulation treatments, i.e. PRP, stem cells, exosomes, growth factors, microneedling, mesotherapy
• •7. LED or low level laser therapy treatments, ie. laser helmets, laser caps, and laser combs
• •8. Infrared saunas
• •Subjects with alopecia other than AGA, such as alopecia areata, alopecia totalis, telogen effluvium, anagen effluvium, and acquired cicatricial alopecia
• •Subjects with a history of bleeding disorders
• •Subjects on anticoagulant medications (aspirin, warfarin, heparin)
• •Subject on autoimmune suppressant medications or suffering autoimmune diseases (e.g. humira)
• •Subjects with an active infection at the local site
• •Subjects with keloidal tendencies
• •Subjects with chronic dermatological conditions affecting the scalp (e.g. eczema, psoriasis, etc.)
• •Subjects with hepatic or renal disease, epilepsy, or any other major medical illness\*
• •Subjects that have undergone evaluation to rule out other causes of hair loss, because underlying causes (e.g., iron deficiency, lupus, thyroid disease, telogen effluvium, post-pregnancy, polycystic ovary, chemotherapy, etc.) would preclude assessment of performance in an androgenetic alopecia trial
• •Subjects who are photosensitive or are using photosensitive drugs or topicals.
• •Subjects who are taking anxiolytics medications
• •Subjects who have been on hormone inhibitors or on hormone replacement therapy in the last 180 days
• •Subjects who are at high risk of seizures
• •Subjects who have a malignancy or a history of malignancies affecting the scalp
• •Subjects that have undergone hair transplantation, scalp reduction, radiation to the scalp or chemotherapy within their lifetime.
• •Subjects with current hair weaves, hair extensions, scalp tattoos, or who use occlusive wigs.
• •Subjects who have used semi-permanent hair products (e.g. color, texturizers or relaxers) within 30 days prior to screening.
• •Subjects with hair shorter than one-half inch (approximately 1.2 cm).
• •Subjects who are unable to make regular follow-up visits.
• •Subjects who are immediate family members (spouse, parent, child, or sibling; biological or legally adopted) of personnel directly affiliated with the study at the investigative sites, or individuals who are directly affiliated with the study at the investigative sites, or individuals directly affiliated with the study sponsor.