Bernstein Medical - Center for Hair Restoration - Lifes2good Inc
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A study published in the December 2015 issue of the Journal of Clinical and Aesthetic Dermatology suggests that Viviscal, an oral supplement designed for women with thinning hair, may promote hair growth. ((Ablon G, Dayan S. 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. J Clin Aesthet Dermatol. 2015 Dec;8(12):15-21.)) The researchers noted a 79 percent increase in healthy, terminal hairs and an almost 12 percent increase in hair diameter in female patients who took the supplement for six months. The evidence suggests that Viviscal may be a useful supplement to current hair restoration treatments, or an alternative treatment in patients not indicated for hair transplant surgery or medical treatment with finasteride.

Background

Viviscal, produced by Lifes2good Inc., out of Chicago, Illinois, was launched in the U.S. in 2008. Its key ingredient is a proprietary mix of powders derived from sustainably-harvested shark and mollusk species. This “amino marine complex,” known as AminoMar C™, is blended with B and C vitamins, and minerals such as calcium, to make Viviscal “Professional Strength.” The active ingredients in the AminoMar complex are glycosaminoglycans (GAGs), a group of long-chain sugar molecules present in many living creatures. GAGs are especially adept at retaining water, and ingesting them may contribute to healthy hair and skin, although it is not clear if taken orally GAGs have any benefit in this regard. According to Viviscal, the beneficial effect on skin and hair of a fish- and protein-heavy diet was first observed in Inuit people in the late 1980s.

Dr. Glynis Ablon and her research team sought to determine if Viviscal “Professional Strength” tablets could successfully treat female hair loss. (The “Professional Strength” blend contains 25mg more of the AminoMar complex than the newer “Extra Strength” variety, as well as a different blend of extracts and additives.) If determined to be a viable treatment, Viviscal could be another option in an otherwise limited market of hair loss products for women. Many women with androgenetic alopecia (common genetic hair loss) are poor candidates for hair transplant surgery. Also, the use of Propecia (finasteride), the most effective hair loss medication available, is not indicated in women due to poor efficacy and the risk of potential side effects.

The Study & Findings

The study observed 40 women, aged 25-66, who self-reported some form of hair loss. An initial densitometry, to determine the progression of hair loss, was conducted on a 4cm2 target area of the frontal hairline. This was followed by the random distribution of either Viviscal or a placebo.

At 90 days on Viviscal, the researchers noted a 56% increase in terminal hairs in the target area and 10% increase in mean hair diameter. A nearly insignificant 1% rise was noted in the number of vellus hairs (non-mature or miniaturized hairs). Compared to the placebo group, the Viviscal group had 57% more terminal hairs, a 10% larger hair diameter, and 9% fewer vellus hairs.

At 180 days, compared to baseline, patients on Viviscal showed an almost 80% increase in terminal hairs, a hair diameter increase of 11.67%, and a 14% increase in vellus hairs. Compared to the placebo group at 180 days the Viviscal group had 77% more terminal hairs, an almost 10% larger hair diameter, and slightly more vellus hairs (1.5%).

Limitations of Ablon Study

The main limitation of the study lies in the potential conflict of interest between the researchers and Lifes2good. Dr. Ablon received a grant from Lifes2good as funding for the December 2015 study. In addition, no clear mechanism of action is proposed.  Finally, the cause of the volunteer’s hair loss was uncertain and probably represents several different diagnoses further confounding any explanation as to why the supplements might work.

Summary

Viviscal has the potential to supplement current treatments for hair loss or provide an alternative treatment for patients not indicated for hair transplant surgery or medical treatment. It would be especially useful for female patients who have relatively limited treatment options. It may also benefit men who are not good candidates for surgery. While the research findings are compelling, more investigation is necessary into the long-term efficacy of Viviscal and the effects of glycosaminoglycans on the hair growth cycle. Further study should be conducted by independent researchers in order to avoid the perception of a conflict of interest.

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A review of research on the efficacy of Viviscal, published in the September 2015 issue of the Journal of Drugs in Dermatology, suggests that the oral supplement may increase hair volume as well as the thickness of healthy, terminal hairs. ((Hornfeldt CS, et al. The Safety and Efficacy of a Sustainable Marine Extract for the Treatment of Thinning Hair: A Summary of New Clinical Research and Results from a Panel Discussion on the Problem of Thinning Hair and Current Treatments. J Drugs Dermatol. 2015 Sep;14(9):s15-22.)) The article presented more than two decades of research on the hair regrowth product and also included a discussion with a roundtable of dermatology and plastic surgery experts.

Both the research review and roundtable discussion point to the benefits of Viviscal, however the article’s conclusions can be questioned due to the appearance of a conflict of interest between the researchers and Lifes2good, Inc., the company that produces Viviscal. Additional independent research needs to determine if Viviscal is a viable and effective hair loss treatment.

Background

Viviscal, was launched in the U.S. in 2008 by Lifes2good Inc., Chicago, Illinois. Its key ingredient is a proprietary mix of powders derived from sustainably-harvested shark and mollusk species. The resulting “amino marine complex,” known as AminoMar C™, is blended with B and C vitamins, and minerals such as calcium to make Viviscal. The active ingredients in the AminoMar complex are called glycosaminoglycans (GAGs), a group of long chain sugar molecules present in many living creatures. GAGs hold water, and ingesting them may contribute to healthy hair and skin – although this is still speculative. According to Viviscal, the beneficial effect on skin and hair of a fish- and protein-heavy diet was first observed in Inuit people in the late 1980s. Viviscal is marketed primarily to women because of the relative dearth of effective hair loss treatments for female patients compared to men.

Review Article

The summary article by Hornfeldt, et al., ((Hornfeldt CS, et al. The Safety and Efficacy of a Sustainable Marine Extract for the Treatment of Thinning Hair: A Summary of New Clinical Research and Results from a Panel Discussion on the Problem of Thinning Hair and Current Treatments. J Drugs Dermatol. 2015 Sep;14(9):s15-22.)) notes that studies dating back to 1992 have suggested that Viviscal may treat hair loss to some degree. ((Lassus A, Eskelinen E, et al. A Comparative Study of a New Food Supplement, ViviScal®, with Fish Extract for the Treatment of Hereditary Androgenic Alopecia in Young Males. J Int Med Res. 1992 Nov;20(6):445-53.)) However, the more recent pivot to testing the supplement in women with thinning hair was pioneered by Dr. Glynis Ablon of the Ablon Skin Institute Research Center, Manhattan Beach, California. In a 2012 pilot study, Dr. Ablon found that Viviscal increased the number of terminal hairs by 211% and 225% after three months and six months, respectively. ((Ablon G. A Double-blind, Placebo-controlled Study Evaluating the Efficacy of an Oral Supplement in Women with Self-perceived Thinning Hair. J Clin Aesthet Dermatol. 2012 Nov;5(11):28-34.)) This was followed by a three month clinical study of women with self-perceived thinning hair; which the author attributed to poor diet, stress, hormones, or abnormal menstruation. In this study, published in early 2015, the mean number of terminal hairs increased by 32%, the count of shed hairs decreased by 39%, and subjects reported a significant increase in quality of life. ((Ablon G. A 3-Month, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Ability of an Extra-Strength Marine Protein Supplement to Promote Hair Growth and Decrease Shedding in Women with Self-Perceived Thinning Hair. Dermatol Res Pract. 2015; 841570.)) A similar randomized, placebo-controlled study, also led by Dr. Ablon and published in December 2015, found that female patients on Viviscal showed an almost 80% increase in terminal hairs and increase of 11.67% in hair diameter. ((Ablon G, Dayan S. 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. J Clin Aesthet Dermatol. 2015 Dec;8(12):15-21.))

Some additional publications, such as Bloch’s 2014 study, ((Bloch L. Demonstrating the efficacy of a nutraceutical for promoting hair growth using a digital photography technique with posterior image analysis. Submitted for poster presentation at the 2015 World Hair Congress, Miami.)) suggest that Viviscal is effective in increasing patients’ hair volume and thickness. Another study published in 2014 suggests that Viviscal may improve scalp coverage and hair fullness in men with common baldness. ((Pinski KS. Patient satisfaction following the use of a hair fiber filler product to temporarily increase the thickness and fullness of thinning hair. Skinmed. 2014;12(5):278-281.))

In the roundtable discussion, which took place in August 2014, dermatology and plastic surgery physicians discussed findings of several clinical studies and reported a positive inclination to offer Viviscal as a treatment option. ((Hornfeldt CS, et al. The Safety and Efficacy of a Sustainable Marine Extract for the Treatment of Thinning Hair: A Summary of New Clinical Research and Results from a Panel Discussion on the Problem of Thinning Hair and Current Treatments. J Drugs Dermatol. 2015 Sep;14(9):s15-22.))

Limitations of Hornfeldt Review

The main limitation of the Hornfeldt article lies in the potential conflict of interest with the researchers and Lifes2good. Dr. Carl S. Hornfeldt received honoraria fees as a consultant for Lifes2good and his co-author of the review article, Mark Holland, is an employee of Lifes2good. Members of the expert roundtable advised Lifes2good on Viviscal or received an honorarium for their participation.

Summary

Viviscal has the potential to offer a new avenue of treatment for treating hair loss or supplementing current therapies. The review article provides a review of research and presents compelling findings over a span of two decades. However, more research is necessary into the long-term efficacy of Viviscal and the effects of glycosaminoglycans on the hair growth cycle. Also, given the appearance of a conflict of interest between the researchers and Lifes2good, it is particularly important that further research be conducted by independent investigators.

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