Study of the Effect of Low Level Laser Light on Hair Growth on the Female Human Scalp

This is an interventional treatment trial for Female Pattern Alopecia Read More

Inclusion Criteria:

• Female pattern androgenic alopecia defined as:

  • discernable decrease in hair density on the top of the scalp relative to the sides and back of the scalp (ii) classifications I-3, I-4, II-1, II-2 according to the Ludwig and Savin Hair Loss Scale
• Notable hair loss/thinning onset within the past five years.
• Progressive/active hair loss/thinning within the last 12 months.
• Skin type I through IV according to the Fitzpatrick Skin Type Scale.
• Healthy, balanced scalp, determined as one that shows no indication of notable: dryness, flaking, dandruff (pityriasis), redness, irritation, inflammation, itching, greasy/oily texture, odor, lesions, scalp acne or other significant dermatological conditions.
• PI or P2 on the American Society of Anesthesiologists (ASA) Physical Status Classification System.
• Willing and able to maintain same hair style, length, color and hair care regimen throughout study participation.

Exclusion Criteria:

• Hair loss attributable to one or more of the following conditions: tinea capsitis, secondary syphilis, discoid lupus erythematosus: Inflammation, alopecia areata, trichotillomania, telogen effluvium, anagen effluvium, traumatic alopecia.
• Use of any of the following medications presently or during the prior 6 months: minoxidil, finasteride (or any other 5ᾳ-reductase inhibitor medications),medication with anti-androgenic properties (e.g. cyproterone, spironolactone, ketoconazole, flutamide and bicalutamide),topical estrogens, progesterone, tamoxifen, anabolic steroids, medications that can potentially cause hypertrichosis (e.g. ciclosporin, diazoxide, phenytoin and psoralens), oral glucocorticoids (inhaled glucocorticoids permitted), lithium, phenothiazines.
• Current use of other prescription and/or over-the-counter products known to affect hair growth and distribution (e.g. saw palmetto, fish oil, corticosteroids, antineoplastic agents, beta blockers, diazoxide, heparin, verapamil, warfarin, etc.).
• Medical, physical, or other contraindications for, or sensitivity to, light therapy (e.g. porphyria, photosensitizing drug therapies).
• Taking Hormonal Replacement Therapy.
• Conditions that may worsen with light therapy.
• History of poor wound healing.
• History of keloid formation.
• Prior hair restoration/transplantation surgery.
• Prior scalp reduction procedure(s).
• Other surgery to the scalp region (e.g. to remove a skin cancer lesion).
• Active skin infection, wound, or other external trauma to the scalp evaluation area.
• Active malignancy or any malignancy in the past five years in the scalp evaluation area.
• Dermatological condition (dermatitis, eczema, psoriasis, etc.) of the scalp other than female pattern hair loss.
• Significant scarring (e.g. from burns) in the scalp evaluation area.
• History of thyroid condition that may influence hair growth and loss.
• Underlying medical condition(s) known to adversely affect hair growth or hair pattern, such as HIV, connective tissue disease, inflammatory bowel disease.
• Current hair weaves.
• Use of non-breathable wigs.
• Hairstyle is a "buzz" cut, defined as hair cut to less than one inch in length.
• Tattooing of the scalp target evaluation area.
• Subject is pregnant, nursing, planning a pregnancy, or less than six months postpartum.
• Serious mental health illness such as dementia or schizophrenia; psychiatric hospitalization in the past two years.
• Developmental disability or cognitive impairment that would preclude adequate comprehension of the informed consent form and/or ability to record study measurements.
• Involvement in litigation/receiving disability benefits related in any way to the parameters of the study.
• Participation in research in the past 30 days.