Accepted: 20 July 2017

DOI: 10.1111/jocd.12400

REVIEW ARTICLE

Growing evidence of the beneficial effects of a marine

protein-based dietary supplement for treating hair loss

Carl S Hornfeldt PhD

Apothekon, Inc., Woodbury, MN, USA

Correspondence
Dr Carl S Hornfeldt, Apothekon, Inc.,
Woodbury, MN, USA.
Email: carl.hornfeldt@apothekon.com
Summary
Background: Hair loss is a common condition among women with a range of causes
including nutritional deficiencies.
Aims: To review the clinical data supporting the use of an oral marine supplement
designed to promote hair growth.
Patients/Methods: Adult women with temporary thinning hair. Following an initial
pilot study, five randomized, double-blind studies assessed the effectiveness of the
oral marine supplement for promoting hair growth. Each study was approved by
one or more institutional review boards.
Results: Together, these studies demonstrated the ability of oral marine supple-
ments to increase the growth of terminal and vellus hairs, increase the diameter of
terminal and vellus hairs, and decrease hair loss. This product is beneficial for men
as well as women.
Conclusions: A dietary supplement containing a marine complex and other natural
ingredients can safely and effectively promote hair growth and decrease hair
shedding in women and men with thinning hair.

KEYWORDS
hair growth, hair loss, nutritional supplement, phototrichogram, thinning hair

1 | INTRODUCTION
Hair loss is a common condition, affecting as many as 50% of
women at some point in their lifetime1 with a range of causes
including illness, medications, physiologic and emotional stress, and
2
nutritional deficiencies. Nutritional deficiencies include inadequate
3,4
intake of proteins, minerals, essential fatty acids, and vitamins.
Due to the significant psychological impact of hair loss, especially
among women,5 a wide range of hair loss therapies have been pro-
moted including oral and topical drugs, hormones, vitamins and diet-
6 7
ary supplements, transplantation, and light-based therapies.
An oral marine supplement has been designed to promote hair
growth in women with temporary thinning hair (Viviscalâ Extra
Strength; Lifes2good, Inc., Chicago, IL, USA). The key ingredients in
this product are AminoMarTM C marine complex, Equisetum arvense (a
naturally occurring form of silica), Malpighia glabra (acerola cherry
providing vitamin C), biotin, and zinc. AminoMarTM C is composed of
a proprietary blend of shark and mollusk powder derived from sus-
tainable marine sources.
Two early double-blind studies assessed the effects of similar
orally administered glycosaminoglycans extracted from marine fish8
and cartilage polysaccharides9 on women with photo-damaged skin.
After 90 days, subjects in the active treatment groups achieved sig-
nificant improvements in skin condition including increased skin
thickness, skin elasticity, and decreased skin redness. In addition,
there were apparent improvements in hair and nail brittleness.8 Sub-
sequently, a double-blind study was specifically designed to assess
the effects of a similar oral supplement containing marine extracts
and a silica compound on young men with hereditary androgenic
alopecia.10 After 6 months, subjects in the active treatment group
achieved a mean 38% increase in nonvellus hairs vs 2% in the pla-
cebo group; 95% of subjects in the active treatment group demon-
strated what the investigators described as clinical and histological
cure vs none of the placebo-treated subjects.

J Cosmet Dermatol. 2018;17:209–213. wileyonlinelibrary.com/journal/jocd © 2017 Wiley Periodicals, Inc. | 209

210 | HORNFELDT
Building on these initial studies, the following review describes
the clinical development of the current marine supplement products
for treating thinning hair in men and women.
2 | OPEN-LABEL PILOT STUDY
The clinical development of the current oral marine supplement
began with an open-label pilot study to evaluate the overall accept-
ability of this product formulation. Female subjects (N = 19) with
self-perceived thinning hair associated with poor diet, stress, hor-
monal influences, or abnormal menstrual cycles were enrolled. 11
Sub-
jects received one tablet every morning and evening following a
meal and were evaluated during the baseline visit and after 4 and
10 weeks of treatment. One subject experienced an adverse event
of headaches during the course of the study which was possibly
11
related to the study drug leading to withdrawal from the study.
Two other subjects withdrew for nonmedical reasons. Among the
subjects completing the study, 13 were Caucasian, two were Asian,
and one was African-American.
At baseline, the mean number of shed hairs (n = 16) was 69.1,
decreasing to 61.0 and 37.0 after 4 and 10 weeks of treatment,
respectively.11 At week 10, most subjects reported improvements in
overall hair volume, scalp coverage, thickness of hair body, hair soft-
ness, hair shine, hair shedding, nail strength, nail growth, and overall
skin health.
3 | DOUBLE-BLIND, PLACEBO-
CONTROLLED STUDY 1
Based on the positive results from the above 10-week study, a ran-
domized, placebo-controlled, double-blind study was conducted to
objectively assess the ability of this marine supplement to increase
hair growth in women with thinning hair.12 This study was IRB
approved. Healthy adult women with Fitzpatrick photo skin types
I-IV with self-perceived thinning hair were randomized to receive
active drug (n = 10) or placebo (n = 5) twice daily for 180 days.
A 2 cm2 area of scalp was selected for hair counts performed at
baseline and after 90 and 180 days of treatment.
Among subjects receiving active product, the mean (SD) number
of terminal hairs was 271.0 (24.2) at baseline, increasing to 571
(65.7) and 609.6 (66.6) after 90 and 180 days of treatment, respec-
tively.12 In contrast, the mean number of terminal hairs among pla-
cebo-treated subjects was 256.0 (24.1) at baseline, remaining at
245.0 (22.4) and 242.2 (26.9) after 90 and 180 days, respectively.
The mean number of vellus hairs among both treatment groups did
not significantly change. After 90 days, significantly more subjects
treated with the active product reported improvements in overall
hair volume, scalp coverage, and thickness of hair body. After
180 days, additional improvement included hair shine, skin moisture
retention, and skin smoothness. There were no reports of adverse
events.
4 | DOUBLE-BLIND, PLACEBO-
CONTROLLED STUDY 2
The objective of this double-blind, placebo-controlled, IRB-approved
study was to build on the results of the previous study by further
evaluating the ability of this marine supplement to promote hair
growth and increase hair diameter in adult women with self-per-
ceived thinning hair (ClinicalTrials.gov Identifier: NCT02297360).13
Healthy adult women with Fitzpatrick photo skin types I–IV and self-
perceived thinning hair associated with poor diet, stress, hormone
influences, or abnormal menstrual cycle were enrolled. Enrolled
participants were Caucasian (n = 59) and Asian (n = 1).
Subjects were randomized to receive one tablet of active product
(n = 30) or placebo (n = 30) every morning and evening after a meal
and were evaluated at baseline and after 90 days of treatment.13 A
2 cm2 area of scalp was again selected for evaluation at baseline
and after 90 days of treatment. Phototrichograms were obtained of
the designated scalp target area at both visits using two-dimensional
digital and macrophotographs. Ten terminal hairs in the target area
were randomly chosen throughout the area and cut at the surface of
the scalp, and digital photographs were obtained to measure hair
diameter. The diameter of 10 hairs was used to obtain a mean hair
diameter for each target area.
Among subjects treated with active product, there was a signifi-
cant increase in the mean (SD) number of terminal hairs from 178.3
(7.8) at baseline to 235.8 (18.4) after 90 days vs 178.2 (9.6) among
placebo-treated subjects at baseline and 180.9 (18.8) at 90 days.13
Similarly, there was a significant increase in the number of vellus
hairs in subjects receiving active treatment from 19.6 (2) at baseline
to 21.2 (2) at 90 days vs 19.8 (2) and 19.9 (2) for placebo-treated
subjects at baseline and day 90, respectively. The active-treated sub-
jects also had a significant decrease in the mean numbers of shed
hairs from 27.1 (27) at baseline to 16.5 (14) at day 90 vs 23.4 (25)
at baseline for placebo-treated subjects and 21.9 (21) at day 90.
There was no significant change in terminal hair diameter in either
group. Subjects treated with active product achieved significantly
higher scores on a 90-day Self-Assessment Questionnaire including
overall hair growth, overall hair volume, scalp coverage, thickness of
hair body, hair strength, growth of eyebrow hair, and overall skin
health. There were no reports of adverse events.
5 | DOUBLE-BLIND, PLACEBO-
CONTROLLED STUDY 3
By this time, the ability of the original marine supplement to signifi-
cantly increase terminal and vellus hair growth and to decrease the
number shed hairs in women after 90 days of treatment had been
clearly demonstrated. The purpose of this randomized, double-blind,
placebo-controlled, IRB-approved study was to assess the effective-
ness of a new professional strength oral supplement (Viviscalâ Pro-
fessional Strength Oral Tablets; Lifes2good, Inc.) (ClinicalTrials.gov
Identifier: NCT02302053).14 Adult women with self-perceived
HORNFELDT
thinning hair associated with poor diet, stress, hormone influences,
or abnormal menstrual cycle and Fitzpatrick skin types I-IV were
enrolled. The subjects completing the study were Caucasian (92%)
and Asian (8%).
Subjects were randomized to receive active (n = 20) or placebo
tablets (n = 20) every morning and evening after a meal and were
assessed at baseline and at 90 and 180 days.14 Similar to previous
studies, efficacy was assessed by changes in the number of terminal
and vellus hairs in a predesignated target area on the scalp using
phototrichogram analysis at the end of the 180-day study period.
The secondary endpoints were changes in terminal hair diameter and
responses to Quality of Life and Self-Assessment Questionnaires.
Among subjects treated with the active product, the mean (SD)
number of terminal hairs significantly increased from 189.9 (15.2) at
baseline to 297.4 (96.1) and 341.0 (60.9) at 90 and 180 days (n = 17),
respectively.14 The mean number of vellus hairs, defined as having a
cross-sectional diameter of ≤40 lM, significantly increased from 19.9
(1.7) at baseline to 20.2 (5.4) and 22.8 (2.3) at 90 and 180 days,
respectively. Mean hair diameter significantly increased from 0.06
(0.007) mm at baseline to 0.07 (0.009) mm and 0.067 (0.009) mm at
90 and 180 days, respectively. There were no increases in any of
these measures among placebo-treated subjects (n = 19). Among sub-
jects treated with active product, improvements were reported for 10
of 12 (83%) items in the Self-assessment Questionnaire and 9 of 13
(69%) items in the Quality of Life Questionnaire. In addition to the
previously demonstrated effects, this study showed the ability of the
new professional strength formulation to significantly increase termi-
nal hair diameter in women with thinning hair.
It is notable that most of the women in the studies described
above were Caucasian, although African-American women are also
susceptible to thinning hair.15 An open-label study assessed the abil-
ity of the professional strength marine supplement to increase hair
growth and hair thickness in African-American women with scarring
alopecia, traction alopecia, or self-perceived thinning hair associated
with poor diet, stress, abnormal menstrual cycle, or other hormonal
influences (N = 16).16 Subjects were instructed to take one tablet
each morning and evening following a meal and were evaluated at
baseline and after 2 and 4 months of treatment.
The results of a baseline Quality of Life Questionnaire revealed
thinning hair results in embarrassment, affects self-esteem, and causes
most subjects to try to hide their thinning hair. After initiating treat-
ment, the greatest change in hair growth and hair quality occurred
during the initial 2 months of treatment. At the end of treatment,
subject-assessed improvements were reported for overall hair volume,
scalp coverage, thickness of hair body, hair shine, and number of hairs
lost on an average day. There were no reported adverse events.
6 | DOUBLE-BLIND, PLACEBO-
CONTROLLED STUDY 4
Based on its beneficial effects for treating women with thinning hair,
the marine complex product was reformulated for use by men
| 211
(Viviscalâ Man; Lifes2good, Inc.). The objective of this double-blind,
placebo-controlled study was to assess the beneficial effects of the
new marine complex supplement in men with thinning hair. (Clini-
calTrials.gov Identifier: NCT02302053).17 Following IRB approval,
healthy men with thinning hair associated with clinically diagnosed
male pattern hair loss based on physical presentation were enrolled.
These included subjects with androgenic alopecia (Norwood Scale
scores 2-3). Subjects were randomized to receive active product
(n = 30) or placebo (n = 30) and were instructed to take one tablet of
their assigned treatment every morning and evening following a meal.
Subjects were evaluated at baseline and on day 90 and day 180.
Similar to previous studies,14 a predesignated target area on the
midline scalp was chosen for two-dimensional digital images and tri-
choanalysis. The mean of three images was used as the final data
result. This study introduced the Hair Pull Test18 which was performed
on the right and left parietal, frontal, and occipital areas of the scalp
during baseline and day 180 visits. Subjects also completed pre- and
post-treatment Quality of Life and Self-Assessment Questionnaires.
Significant increases were observed for all efficacy measures.17
The mean (SD) Total Hair Count increased from 162.2 (46.9) at
baseline to 169.1 (43.4) and 174.9 (44.0) at days 90 and 180,
respectively; Total Hair Density increased from 159.7 (46.3) at base-
line to 166.5 (42.7) and 172.2 (43.3) at days 90 and 180, respec-
tively; and Terminal Hair Density increased from 121.9 (40.0) at
baseline to 127.7 (39.21) and 130.3 (38.8) at days 90 and 180,
respectively. In contrast, there was no improvement in placebo-trea-
ted subjects. Subjects indicated significant overall improvement in
Quality of Life at day s 90 and 180 and substantial improvement in
overall satisfaction at day 180. The results of the Hair Pull Test were
significantly improved for the active treatment vs placebo at day 90
and day 180. There were no reports of adverse events.
7 | DOUBLE-BLIND, PLACEBO-
CONTROLLED STUDY 5
The objective of this 180-day study was to expand on the results of
the initial double-blind, placebo-controlled study12 by the addition
of a shed hair count analysis and a phototrichogram-based analysis
of hair fiber diameter. This study was IRB-approved (ClinicalTrials.
gov Identifier: NCT02288858).19 Adult female subjects with self-
perceived thinning hair were enrolled (N = 96). As in previous
studies, the majority (71%) were Caucasian and Fitzpatrick skin types
I-III. A predesignated area of the scalp was again selected for
two-dimensional digital images and trichoanalysis. Subjects were
randomized to receive one tablet of the active treatment (n = 48) or
placebo (n = 48) three times daily. Subjects were evaluated during
the baseline visit and after 2 days, 3 and 6 months. Shed hair was
collected during shampooing and counted during each visit. Digital
photography was repeated at each visit and hair counts repeated at
3 and 6 months.
Among subjects randomized to active treatment, mean hair shed-
ding was significantly reduced from 52.1 (59.5) at baseline to 42.6
212 | HORNFELDT
(45.2) at 3 months and 42.7 (41.7) at 6 months (n = 37). Among pla-
cebo-treated subjects, the mean number of shed hairs was 45.7
(55.0) at baseline, increasing to 70.5 (120.8) at 3 months, and then
decreasing to 48.8 (69.2) at 6 months (n = 34).19 In addition, mean
hair diameter of vellus-like hair showed a small but statistically sig-
nificant increase among subjects receiving active treatment after 3
and 6 months of treatment (n = 30) vs no change among placebo-
treated subjects (n = 26).
8 | DISCUSSION
The results of the initial study are believed to represent the first
description of increased hair growth in women associated with the
use of a nutraceutical product.12 Since that time, the ongoing series
of studies have demonstrated the ability of this nutritional supple-
ment containing proprietary marine supplement to promote the
growth of terminal and vellus hairs, increase hair diameter, and
decrease hair loss.13,14,17,19
An association between inadequate nutrition and hair loss has
previously been described.20-24 Not surprisingly, several studies
have demonstrated the ability of vitamins, omega fatty acids, and
antioxidants to improve hair growth.25-27 The studies described
here further demonstrate the clinical benefit of dietary supplements
for the treatment of hair loss. This is especially important for
women who are more likely to suffer from nutritional deficiencies
than men and are more likely to experience emotional distress due
to hair loss.28
Another product containing marine protein in combination with
other natural ingredients has been shown to improve the appearance
and quality of photoaged skin in men29 and women.30 Specific
improvements included wrinkles, fine lines, solar melanoses, other
hyperchromias, erythema, hydration, radiance, sebum, smoothness,
and overall skin appearance.29,30 These improvements were corre-
lated with increased collagen and elastin fibers in the skin.29,31
Although the emphasis on the product described in this review has
been improvements in hair loss, improvements in general skin health
have also been reported.12,13
Although there are numerous pharmaceutical products available
for the treatment of hair loss,6 none are completely effective and
may be associated with adverse effects or are unsuitable for use in
some women.32 In addition to promoting hair growth, and in con-
trast to pharmaceutical products, this marine supplement provides
the added benefit of providing subjective improvements in the
appearance of skin, nails, eye lashes, and eye brows in women13,14
and nail and skin quality in men.17
9 | CONCLUSIONS
A dietary supplement containing a marine complex and other ingre-
dients can safely and effectively promote hair growth and decrease
hair shedding in women and men with thinning hair.
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How to cite this article: Hornfeldt CS. Growing evidence of
the beneficial effects of a marine protein-based dietary
supplement for treating hair loss. J Cosmet Dermatol.
2018;17:209–213. https://doi.org/10.1111/jocd.12400