A Randomized, Double-blind, Placebo-controlled, Multi-center, Extension Trial Evaluating the Efficacy of a New Oral Supplement in Women with Self-perceived Thinning Hair.

As physicians, we may look at a patient and think she has no problem with hair thinning or hair loss, but she may feel very strongly that her hair is thinning. Hair loss in women can appear as early as in their 20s, and with environmental stress, internal stress, multiple medications, and dietary insufficiencies, can often progress. While androgenetic alopecia is a common cause of male pattern hair loss in men and a less common cause of female pattern hair loss in women,1 this study is not one of androgenetic alopecia. Among women, hair loss is more likely to be due to medications,2 nutritional deficiency,3 and physiological or emotional stresses, such as illness or childbirth.2,4-7 Hair loss and decreased hair fiber thickness are reasons for many older women becoming dissatisfied with their hair8 and for many, hair loss may be associated with symptoms of depression9 and diminished quality of life.10 The authors wanted to determine if patients with self-perceived thinning hair due to daily life stressors (not a specific trigger inducing hair loss as seen with telogen effluvium), nutritional insufficiency (fast food, poor diet), and aging (again not androgenetic alopecia with retention of frontal hair line or central part of scalp) would truly benefit from a new all natural, oral supplement. The product containing proteins and glycosaminoglycans of marine origin and other natural compounds has been developed for the treatment of androgenetic alopecia (Vivisca® Hair Nourishment System, Lifes2good, Inc., Chicago, Illinois). This product does not contain hormones, drugs, or industry by-products but it provides essential nutrients to nourish hair naturally. Two 8- and 12-month open-label studies11,12 have demonstrated the efficacy of this product for the treatment of alopecia in men. The results of the authors’ recent pilot study, published in The Journal of Clinical and Aesthetic Dermatology in November 2012, showed that the oral supplement was also effective in women with thinning hair due to poor diet, stress, hormonal influences, or abnormal menstrual cycles.13 Subjects enrolled in that study achieved a significant increase in the number of terminal hairs among Viviscal-treated subjects after 90 and 180 days of daily treatment. In addition, significantly more Viviscal-treated subjects perceived improvements in overall hair volume, scalp coverage, thickness of hair body, hair shine, skin moisture retention, and skin smoothness after 180 days. Further studies are also being conducted to establish the molecular mechanism by which the new oral supplement promotes hair growth. While the exact mechanism of this product is unknown, some of the preliminary data from early in vitro studies have shown that the polysaccharide complexes in it have greater bioavailability when compared with similar products (unpublished results). In addition, this new product has been shown to enhance the proliferation of dermal papillae (DP) cells. DP cells have been shown to play an important role in orchestrating the hair growth cycle.14,15 Initial studies have shown that this new supplement increases alkaline phosphatase (AP) levels in DP cells (unpublished results). AP is a key marker of the anagen phase; therefore, an increase in its expression suggests an increase in the quantity of DP cells that are actively growing during the anagen phase.15-17 Thus, in vitro examination of the molecular mechanism of Viviscal is consistent with the results of the existing Viviscal clinical studies, where daily intake promotes existing hair growth. A new professional strength supplement has been specifically designed to promote hair growth in women suffering from temporary thinning hair (New Vivisca® Professional Strength Oral Tablets, Lifes2good, Inc., Chicago, Illinois). The purpose of this multi-center randomized, double-blind, placebo-controlled study was to test the hypothesis that the administration of a new oral supplement for 180 days will promote the growth of terminal hairs and increase hair diameter in a larger group of adult women with self-perceived thinning hair, adding the factor of hair diameter changes due to the product in our evaluation. Figure 1 Changes in hair growth, Patient 1. Top Row. Macrophotographs of the selected target area at baseline (left), 90 days (center), and 180 days (right). Bottom row. Digital images of the selected target area at baseline (left), 90 days (center), and 180 days ... Figure 2 Changes in hair growth, Patient 2. Top Row. Macrophotographs of the selected target area at baseline (left), 90 days (center), and 180 days (right). Bottom row. Digital images of the selected target area at baseline (left), 90 days (center), and 180 days ...