Safety and Efficacy of Deeply Rooted® Nutraceutical for Hair Growth in Women

Hair loss can significantly affect quality of life. Patients seeking treatment for hair loss find that many surgical or medication options involve significant risks or side effects. DEEPLY ROOTED® is a nutritional supplement that combines botanical and natural ingredients with the goal of effectively reducing hair loss and stimulating hair growth—without the side effects of many standard treatments. DEEPLY ROOTED’s active ingredients have both anti-inflammatory and adaptogenic properties, and inhibit dihydrotestosterone without the use of hormones, drugs, or industry by-products. This 3-month prospective study evaluates the effectiveness of DEEPLY ROOTED® for the prevention of hair loss. Healthy female subjects complaining of hair loss were enrolled, and supplied with three months of DEEPLY ROOTED® , without other compensation. The primary endpoint was a significant increase in hair growth. This was measured using anonymously collected patient data to evaluate hair growth and quality, as well as blinded Investigator hair assessment data. Patients who ingested DEEPLY ROOTED® over a three-month period reported noticeable improvement of hair growth (91%), increased hair volume (86%), and improved hair quality (86%). Subjects were noted to exhibit an increase in the number of new hairs, hair thickness and scalp coverage. No significant adverse effects were reported. DEEPLY ROOTED® safely helped over 90% of otherwise healthy women with self-perceived hair thinning to improve hair quality and quantity. The unique combination of botanical and natural ingredients provided a drug-free alternative for the management of hair loss. 1. Introduction Hair loss, known as alopecia, affects more than 50% of men and women over age 50. Although not life-threatening, such hair loss impacts a patient’s quality of life, self-esteem, and overall sense of wellness. Female pattern hair loss (FPHL) is the most common form of alopecia in women. Affected women may experience psychological distress and impaired social functioning. Early diagnosis and treatment are desirable to avoid the progression of hair loss, and to stimulate regrowth. Typically, a diagnosis of FPHL can be confirmed by reviewing a patient’s medical history and a physical examination [1]. Considering the impact of alopecia on well-being, there is a growing interest in novel therapeutic options. To date, two medications—minoxidil and finasteride—are approved by the FDA for the treatment of alopecia. Unfortunately, these drugs carry the risk of significant side effects ranging from dermatitis to male sexual dysfunction and female infertility [2]. As an alternative to prescription medications, a number of plant-based supplements, vitamins and minerals are available to reduce or even help reverse hair loss. Determining what products are effective is challenging in this less regulated free-market environment. This study aims to evaluate the effectiveness of the nutraceutical DEEPLY ROOTEDÒ on hair growth and quality by monitoring three-month outcomes on otherwise healthy females, using direct observation and photography, as well as through patient questionnaires. 2. Materials and Methods To evaluate the safety, efficacy and physiological effects of DEEPLY ROOTEDÒ supplement, 40 female subjects with FPHL were enrolled over a 4-week period. Symptomatic volunteers were solicited among patients at a plastic surgery office/med spa and a dermatology practice. Patients complaining of female pattern hair loss were offered the opportunity to participate, which was voluntary and involved no compensation other than free product. The study was designed as a single arm study and approved by institutional review board. The total duration of the study was 4 months as patients took supplements for 3 months. Inclusion criteria for patients was: female gender, age 21 - 65, no major comorbidities, self-perceived thinning hair determined on initial study assessment, Fitzpatrick I-IV photo skin types. Exclusion criteria was any known allergy or sensitivity to any shampoo/conditioner, women who were nursing, pregnant, planning to become pregnant during the study or who have been pregnant within the last 6 months, females with known stressful incident within the last six months (i.e. death in family, miscarriage), females who have recently (within the last 6 months) started the use of hormones for birth control or hormone replacement therapy (HRT), women who had regularly used Rogaine (Minoxidil) within the last 3 months or oral prescription medications, females suffering from other hair loss disorders, such as alopecia areata, scarring alopecia, androgenetic alopecia and telogen effluvium [3]. Subjects were given a three-month supply of DEEPLY ROOTED supplement with instructions to take four capsules daily. The dose of ingredients of each capsule is listed on the product label (Table 1). The effects of the supplement were evaluated prospectively using standardized photography (before and after) combined with a patient questionnaire to evaluate results. Photographs, using a Canon Power Shot G16 camera with a standard 6.1 - 30.5 mm Canon zoom lens, were obtained of the scalp in five views (front, left, right, posterior and birds-eye). A Dermlite photo 3 camera was used to take close-up pictures of each patient’s temporal area. At the end of three months, all patients completed a questionnaire evaluating the effects of DEEPLY ROOTEDÒ on hair growth and quality. 3. Results Of the 40 subjects initially enrolled in the study, two were later excluded: one because of a previously undisclosed diagnosis of autoimmune thyroid disease, and another patient with history of chronic rosacea. DEEPLY ROOTEDÒ does