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
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Table 1. DEEPLY ROOTED ingredient list.
contain green tea extract, which can exacerbate Rosacea in sensitive patients. The remaining 38 women took DEEPLY ROOTEDÒ for three months. Two women reported non-adherence to instructions, often forgetting to take the supplement regularly, so they too were excluded from the study. Finally, three additional patients failed to return in a timely fashion for evaluation and questionnaire completion. Thus, 33 patients successfully completed the study.
All 33 patients were otherwise healthy women with female pattern hair loss. All underwent examination at the beginning of the study, and a health screening was completed to rule out other hair loss disorders or other treatments. Ethnicity of the patients was 26 Caucasian (79%), 3 Hispanic (9%), 4 Asian (11%) and one African American (3%). None of the patients were taking other supplements or hair growth medications and none had undergone surgical hair restoration. All patients were given a three-month supply of DEEPLY ROOTEDÒ supplement, and a 24-hour hotline was established for patients to call with questions or to report any side effects. No adverse events were reported. After three months of supplementation, these 33 participants completed an anonymous questionnaire (see Addendum 1 for questionnaire) to assess the effects of DEEPLY ROOTEDÒ.
Results of the questionnaire revealed 30 out of 33women (91%) reporting overall improved hair growth; 26 (78%) reported increased hair volume, 27 (81%) reported improved hair quality, and 25 (76%) noted new hair growth with DEEPLY ROOTEDÒ. Of these, 24 (73%) perceived an increase in total hair amount and 23 (70%) noticed improved scalp coverage. Finally, 22 (67%) of patients perceived their hair as thicker with DEEPLY ROOTEDÒ (see Table 2).
In addition to the patients’ self-reported results, all photos were evaluated in a blinded fashion. Images were de-identified and the evaluator was not aware of the patients’ self-reported results (which were collected anonymously). Three sets of images were excluded from patients who had dramatically altered their hair color and style, making the before and after images difficult to compare. The evaluators were asked to compare the before and after scalp images (see patient photographs, Figure 1 and Figure 2) and determine if the patient’s hair appeared as improved, without noticeable change, or worsened. Seventy percent
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Table 2. Results of the patient questionnaire.
of the images were rated as improved, 30% as no change, and none were deemed worsened. The study subjects did not undergo tattooing to mark the close-up scalp area to precisely identify the hair-bearing area compared. Sample microscopy
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Figure 2. Representative macroscopy photos of study patients showing higher hair density after three months of DEEPLY ROOTEDÒ supplementation.
images are presented, but were not used for assessment of the results, since the scalp locations were not exactly the same.
4. Discussion
Hair loss is a complex problem that affects millions of men and women worldwide, causing many to experience lower quality of life and decreased self-esteem. Treatment has mostly relied on prescription medications and/or hair transplantation.
The frequency of FPHL varies among population groups and ordinarily increases with age. The age of onset for FPHL is during the reproductive years, which is later than in men. Twelve percent of women first develop clinically detectable FPHL by age 29 years, 25% by age 49 years, and 41% by 69 years. For women over 70, FPHL reaches a rate of 42% and >50% have some element of FPHL by age 79 [4]. Nevertheless, there is a greater demand for treatment among patient’s ages 25 to 40 years [5].
FPHL and male balding share a final common pathway of follicular regression, but current knowledge suggests that the etiology is not necessarily the same in both sexes. Androgens are a key driver of male balding and also involved in the etiology of pattern hair loss in some women. However, other non-androgenic factors that are still unidentified likely play a role in causing FPHL [6].
Hair loss in women is polygenic and multifactorial, with the additional influence of environmental factors. Several studies focused on the importance of several genes related to alopecia. FPHL involves progressive hair follicle miniaturization and subsequently the conversion of terminal follicles into vellus-like follicles. These vellus-like follicles have a shortened hair cycle because of a reduction in the anagen phase, which leads to the production of short and fine hair shafts. The miniaturization is not as uniform nor as intense in women. For this reason, areas of complete baldness are very rare in women [2]. The aim of FPHL treatment should reverse or at least stabilize the process of hair follicle miniaturization.
As an alternative to prescription medication, many botanical products and dietary supplements are available, but often lack scientific evidence to support their efficacy. Low-quality supplements are sometimes produced without scientific guidance and without appropriate quality control. Some products have been recalled by the FDA because of patient illness or other side effects.
This study demonstrates that a significant majority of healthy women with FHLP reported improved hair growth, volume, quality and increased new hair after supplementing with DEEPLY ROOTEDÒ. None of the participants reported any significant adverse effects. This study was purposefully designed to replicate prior studies reporting high efficacy for nutraceuticals. The investigators in this study took the conscious decision to not enroll paid participants, and to gather feedback on a de-identified basis to minimize any participant bias.
Hush and HushÒ DEEPLY ROOTEDÒ is designed for management of hair loss. The botanical and natural ingredients were chosen with the goal of effectively reducing hair loss and to stimulate new hair growth. DEEPLY ROOTEDÒ contains no hormones, drugs, or industry by-products. Notably, many of the ingredients in DEEPLY ROOTEDÒ have shown effects on scientific studies that were comparable to prescription medications—without the side effects of these standard treatments.
DEEPLY ROOTEDÒ is a formulation of botanicals with potent anti-inflammatory, anti-stress adaptogenic, antioxidant and DHT-inhibiting properties—combined to synergistically combat the multiple underlying factors that compromise hair growth and health. Some patented ingredients include Amla fruit, Ashwagandha, Horsetail whole extract, Green leaf tea extract, Coconut water, Tocotrienol, Pumpkin seed oil and Saw Palmetto, all of which are standardized and clinically tested.
The benefits of nutritional supplementation with amino acids, biotin, zinc, and other micronutrients in hair loss have been previously described. A relationship between low levels of serum ferritin or vitamin D resulting in FPHL has been described [7]. Vitamin D has been suggested as a micronutrient necessary to delay aging phenomena, including hair loss. Vitamin D receptor activation plays an important role in anagen initiation, and recent data suggested that vitamin D receptors regulate the expression of genes that are required for hair follicle cycling. The combination of micronutrients and botanical supplements contained in DEEPLY ROOTEDÒ may have anti-androgenic and anti-inflammatory properties. Taken as a nutritional supplement for three months, DEEPLY ROOTEDÒ promoted increased hair growth in 91% of volunteers.
5. Conclusion
Supplementation with DEEPLY ROOTED® over a three-month period appears to successfully improve symptoms of self-perceived thinning hair, resulting in increased hair growth, strength, volume, quality, thickness, and improved scalp coverage. Supplementation resulted in no adverse events or side effects reported. DEEPLY ROOTEDÒ supplementation should be considered as an appropriate treatment option in the management of female pattern hair loss.
Addendum 1
PATIENT QUESTIONANIRE DEEPLY ROOTED STUDY
Instructions: Please complete the following questions by circling the number in the column which best describes your opinion of the change you have seen throughout the durations of the study (compared to baseline) for each characteristic.