Original Contribution

Journal of Cosmetic Dermatology, 0, 1--9

A 6-month, randomized, double-blind, placebo-controlled study

evaluating the ability of a marine complex supplement to promote
hair growth in men with thinning hair
Glynis Ablon, MD, FAAD
Ablon Skin Institute and Research Center, Manhattan Beach, CA, USA

Summary Background Male pattern baldness, or androgenetic alopecia, affects approximately

50% of the adult population and can cause poor self-image, low self-esteem and have
a significant negative impact on the quality of life. An oral nutraceutical supplement
based on a marine complex formulation has previously been reported to significantly
increase the number of terminal hairs in women with thinning hair. AIMS: The
objective of this double-blind, placebo-controlled study was to confirm the beneficial
effects of a similar marine complex supplement in adult male subjects with thinning
hair (Viviscal Man; Lifes2good, Inc., Chicago, IL, USA).
Patients/Methods Healthy adult male subjects with thinning hair associated with
clinically diagnosed male pattern hair loss were enrolled and randomized to receive
study drug or placebo twice daily.
Results At Day 90, subjects indicated a significant improvement in three of six quality
of life measures as well as a significant overall improvement in quality of life. After
180 days, significant increases were observed for total hair count, total hair density,
and terminal hair density (for each, P = 0.001). The investigator assessments
revealed significant improvements in terminal and vellus hair count and terminal
hair density. Hair pull test results were significantly lower (fewer hairs removed) for
study drug vs. placebo at Days 90 (P < 0.05) and 180 (P < 0.01). There were no
reports of treatment-emergent adverse events.
Conclusion The results of this study showed for the first time that a dietary
supplement containing a marine complex and other ingredients can decrease hair
shedding and promote hair growth in men with thinning hair.
Keywords: male pattern baldness, androgenetic alopecia, clinical trial, hair growth
supplement, shark and mollusk powder

the adult male population.1 While baldness is a rel-

Introduction
Male pattern baldness, or androgenetic alopecia, is a
common condition affecting approximately 50% of
Correspondence: Glynis Ablon, Associate Clinical Professor UCLA, Ablon
Skin Institute and Research Center, 1600 Rosecrans Avenue, Building 4B,
Manhattan Beach, CA 90266, USA. E-mail: drablon@abloninstitute.com
Accepted for publication July 21, 2016
atively benign condition, it can cause feelings of
poor self-image, low self-esteem, anxiety, and depres-
sion,2,3 which may have a significant negative
impact on the quality of life.4 Some prescription
treatments for androgenic alopecia have the poten-
tial to cause significant adverse events.5 A safe and
drug-free nonprescription alternative is desirable for
these patients.

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Marine complex supplement promotes hair growth . G Ablon
Several so-called nutraceuticals for skin and hair con-
ditions have appeared in the market place over the last
few years. A novel oral compound consisting of proteins
and glycosaminoglycans of marine origin was found to
have beneficial effects when administered to women
with sun-damaged skin.6,7 The results of two studies
demonstrated improvements in the appearance of sun-
damaged skin and increased the skin thickness and
elasticity. Brittle hair and nails returned to normal after
90 days of treatment.6,7 Subsequent research studied
the use of a similar marine extract combined with other
natural compounds. The efficacy of this marine extract
for treating male androgenetic alopecia was demon-
strated in 8- and 12-month open-label studies (Majas
M, Puuste O, Pr asthacka B et al, unpublished).8
More recently, a nutraceutical supplement based on
a new marine complex formulation has been developed
to promote the hair growth (Viviscal, Lifes2good, Inc.,
Chicago, IL, USA). This supplement is formulated with
a proprietary blend of extracellular matrix components
from shark and mollusks (AminoMarTM, Chicago, IL,
USA) derived from sustainable marine sources.9 Two
double-blind, placebo-controlled studies confirmed that
this marine complex supplement taken twice daily for
90 days can significantly increase the number of termi-
nal hairs in women with thinning hair.10,11 It also
improved the subject self-assessment scores,11 reduced
hair shedding, and improved the Quality of Life Ques-
tionnaire scores.10 A third double-blind, placebo-con-
trolled clinical trial showed that hair shedding was
significantly reduced in the first 36 months of treat-
ment and phototrichogram image analysis revealed a
significant increases in the mean vellus-like hair diame-
ter after 6 months.12 The beneficial effects of a new
professional strength marine complex formulation have
recently been demonstrated for 180 days.13
Because it is clearly beneficial for treating female
hair loss, the current marine complex product has
been reformulated for use by men with thinning hair
(Viviscal Man, Lifes2good, Inc.). The purpose of this
double-blind, placebo-controlled study was to confirm
the beneficial effects of the new marine complex sup-
plement in adult male subjects with thinning hair.
Materials and methods
Subjects
Inclusion criteria
Healthy male adult subjects with thinning hair associ-
ated with clinically diagnosed male pattern hair loss
based on physical presentation of hair loss and family
2 2016 Wiley Periodicals, Inc.
history were enrolled. They included subjects with
androgenic alopecia, Norwood Scale scores of 23
only. Each subject expressed his willingness to main-
tain a consistent haircut, hair color, and shampooing
frequency and make no substantial changes in their
current diet, medications, or exercise routine for the
duration of the study. Other enrollment criteria
included a body mass index of 29 kg/m2 and Fitz-
patrick photo skin types IIV. Subjects received a mod-
est stipend for each completed visit.
Exclusion criteria
Reasons for exclusion from study participation included
a history of intolerance or allergy to fish, seafood/shell-
fish, acerola, or any of the ingredients in the study drug;
allergy or sensitivity to any shampoo or conditioner;
prior hair transplants; current use of light therapy to
treat thinning hair, regular use of minoxidil or other
topical hair growth products, or finasteride within the
previous 6 months; hair loss disorders such as alopecia
areata, scarring alopecia, or telogen effluvium; use of
medications known to cause hair thinning or hair loss;
self-reported uncontrolled diseases, such as diabetes,
hypertension, or hyperthyroidism; self-reported active
hepatitis, immune deficiency, HIV, or autoimmune dis-
ease; an active dermatologic condition which, in the
opinion of the examining investigator, might place the
subject at risk or interfere with clinical evaluation; cur-
rent participation in another clinical research study.
Study drug
Enrolled subjects were randomized 1:1 to receive pla-
cebo or the study drug, a commercially available hair
regrowth supplement (Viviscal Man; Lifes2good, Inc.).
Each tablet contains vitamin C (from acerola powder
and ascorbic acid), zinc (from zinc oxide), AminoMarTM
Marine Complex (shark powder and mollusk powder)
452.9 mg, horsetail (stem) extract 24.5 mg, and flax
seed extract 50 mg. Other ingredients include micro-
crystalline cellulose, maltodextrin, hydroxypropyl
methylcellulose, silicon dioxide, magnesium stearate,
glycerol, artificial orange flavoring, and modified
starch. The placebo was an inert table with similar
appearance and taste. Subjects were instructed to take
one tablet of their assigned treatment every day in the
morning and evening with water following a meal.
Procedures
Subjects were evaluated at Day 0 (Visit 1), Day 90
(Visit 2), and Day 180 (Visit 3). A physical examina-
tion was performed at each visit, including a review of
 Marine complex supplement promotes hair growth . G Ablon

basic body systems, scalp examination, vital signs, and
BMI. At Visit 1, the scalp was examined by the investi-
gator to rule out any confounding scalp conditions.
Table 1 Quality of life questionnaire
Please complete the following questions by circling the number in the
column which best describes your opinion for each characteristic.

Digital photography and trichoanalysis Very A A Not Not

The investigator selected a 1.5-cm-diameter (2.35 cm2) much lot little at all relevant
target area on the midline scalp defined as the half-
1. I feel my thinning hair 4 3 2 1 0
way point on the coronal band created from the left
makes me look less attractive.
preauricular skin pit to the right preauricular skin pit 2. Because of my thinning hair, 4 3 2 1 0
directly across the top of the head. The target area was I have considered a hair
marked using a black fine-tip skin marker. This area transplant.
3. My thinning hair makes me 4 3 2 1 0
was prepared by being shaved and dyed with tempo- feel older.
rary black hair color for trichoanalysis. Digital two- 4. My thinning hair affects my 4 3 2 1 0
dimensional images of the target site and parietal, fron- self-confidence.
tal, and occipital areas were obtained for each subject 5. Because of my thinning hair, 4 3 2 1 0
I am not as confident when
using standardized lighting (IntelliStudio, Canfield Sci- asking for a date.
entific, Inc., Parsippany, NJ, USA).14 Computerized tri- 6. Because of my thinning 4 3 2 1 0
chogram images (TrichoScan, Tricholog GmbH, hair, I feel self-conscious
Regensburg, Germany)15 were obtained using a hand- when I go to the gym.

held dermatoscope (DermoGenius, DermoScan GmBH,

Regensburg, Germany).16 The mean of three images
was used as the final data result.
Hair pull test
Subjects were required to refrain from hair washing for at
least 3 days (72 h) prior to the hair pull test, which was
performed on the right and left parietal, frontal, and
occipital areas of the scalp during Visits 1 and 3. As
described by Shapiro and colleagues, the test was per-
formed by grasping a bunch of 5060 hairs between the
thumb, index finger, and middle finger at their base. The
investigator firmly but not forcefully tugged away from
the scalp so that the fingers slid along the hair fibers and
the number of extracted hairs was counted. The loss of
more than six hairs (10%) in each area was considered a
positive test and suggests active hair shedding.17
Questionnaires
Each subject completed a General Lifestyle Question-
naire (Visit 1), a Quality of Life Questionnaire (Visits 1,
2, and 3; Table 1), and a Self-Assessment Question-
naire (Visits 2 and 3; Table 2), and the investigator
also completed the following hair quality assessments
at Visits 2 and 3: right parietal hair count, left parietal
hair count, terminal count, vellus count, total hair
count, total hair density, and terminal hair density.
Study endpoints
Efficacy
The primary efficacy parameters from the trichoanaly-
sis were (1) total hair count, (2) total hair density, (3)
terminal hair density, (4) and vellus hair density. Ter-
minal hairs were defined as coarse, short, or long hairs
found on the scalp with cross-sectional diameter of
40 lM. Vellus hairs were defined as fine, short hairs
found on the scalp with a cross-sectional diameter of
<40 lM.
Secondary efficacy measures were the results of the
90- and 180-day hair pull test and 90- and 180-day
Quality of Life and Self-Assessment Questionnaires.
Safety
Subjects were queried about adverse events at each
clinic visit and were encouraged to contact the investi-
gator at any time to report the possible adverse events.
Ethics
This study followed applicable guidelines for the protec-
tion of human subjects for research as outlined in the
United States FDA 21 CFR Part 50, in accordance with
the accepted standards for good clinical practices
(GCPs) and the standard practices of Ablon Skin Insti-
tute Research Center. Each subject provided informed
consent, a photographic release, a confidentiality agre-
ement, and HIPAA form. This protocol and associated
documents were approved by a commercial IRB (IRB
Company Inc., Buena Park).
Primary and secondary efficacy measures were col-
lected at Visits 1, 2, and 3, and descriptive statistics
were generated for all variables. A repeated-measures
ANOVA was conducted to determine whether there

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Marine complex supplement promotes hair growth . G Ablon

was a statistically significant difference in primary Primary efficacy measures

and secondary efficacy parameters. The primary effi-
cacy data were approximately normally distributed at
each time point, as assessed by graphical methods.
The assumption of sphericity was not met, as
assessed by Mauchlys test of sphericity as calculated
according to Greenhouse and Geisser.18 All analyses
were two-tailed, where applicable, with P-value of
0.05. All analyses were performed using IBM SPSS
Statistics, version 19 (IBM Corporation, Armonk, NY,
USA).
Results
Subjects enrolled in the study drug group (N = 30)
had a mean (SD) age of 42.8 (7.7) years and a mean
BMI of 25.8 (2.1) kg/m2. Subjects enrolled in the pla-
cebo group (N = 30) had a mean age of 46.1 (7.6)
years and a mean BMI of 26.6 (1.9) kg/m2.
Significant increases were observed for all efficacy mea-
sures. Mean (SD) total hair count increased from
162.20 (46.96) at baseline to 169.08 (43.40) and
174.89 (44.00) at Days 90 and 180, respectively
(P = 0.001); total hair density increased from 159.71
(46.26) at baseline to 166.50 (42.74) and 172.17
(43.29) at Days 90 and 180, respectively (P = 0.001);
and terminal hair density increased from 121.95
(40.04) at baseline to 127.65 (39.21) and 130.34
(38.81) at Days 90 and 180, respectively (P = 0.001;
Table 3). There was no improvement in placebo-trea-
ted subjects. Treatment with the study drug did not
improve the mean vellus hair density (P = 0.171);
however, these results were highly variable and con-
tained two substantial outliers. Visible improvement in
hair growth is apparent in two representative subjects
shown in Figures 1 and 2. Improvements in efficacy
measures for these subjects are provided in Table 4.

Table 2 Self-Assessment questionnaire

Please review each of the parameters below and check the most appropriate answer.

Greatly Moderately Slightly Slightly Moderately Greatly

increased increased increased No change decreased decreased decreased

1. Overall hair growth 7 6 5 4 3 2 1

2. Overall hair volume 7 6 5 4 3 2 1
3. Scalp coverage 7 6 5 4 3 2 1
4. Hair shine 7 6 5 4 3 2 1
5. Hair strength 7 6 5 4 3 2 1
6. Nail strength 7 6 5 4 3 2 1
7. Nail growth rate 7 6 5 4 3 2 1
8. Growth of eyebrows 7 6 5 4 3 2 1
9. Growth of eyelashes 7 6 5 4 3 2 1
10. Skin smoothness 7 6 5 4 3 2 1
11. Overall skin health 7 6 5 4 3 2 1

Table 3 Efficacy results

Baseline Day 90 Day 180 Significance

Total hair count

Marine complex formulation 162.2 (46.96) 169.08 (43.40) 174.89 (44.00) P = 0.001
Placebo 152.2 (42.80) 151.33 (41.52) 146.92 (47.42) NS
Total hair density
Marine complex formulation 159.71 (46.26) 166.50 (42.74) 172.17 (43.29) P = 0.001
Placebo 150.00 (42.14) 149.01 (40.87) 144.71 (46.74) NS
Terminal hair density
Marine complex formulation 121.95 (40.04) 127.65 (39.21) 130.34 (38.81) P = 0.001
Placebo 104.72 (37.84) 101.73 (38.89) 99.17 (42.21) NS

Each value represents the mean (standard deviation). NS, not significant.

4 2016 Wiley Periodicals, Inc.


TrichoScan images for these subjects are provided in
Figures 3 and 4.
Secondary efficacy measures
At Day 90, subjects indicated a significant improve-
ment in three of six quality of life measures and a sig-
nificant overall improvement in quality of life
(a)
(b)
(c)
Figure 1 Visible Hair growth in Subject 1. The improvement in
baseline hair appearance (a) is apparent in the 42-year-old Cau-
casian man after twice-daily treatment with the marine complex
formulation for 90 days (b) and 180 days (c). The improvements
in study endpoints for this patient are summarized in Table 4.
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Marine complex supplement promotes hair growth . G Ablon
(Table 5). By Day 180, only one question remained
significantly improved (My thinning hair affects my
self-confidence); however, a fourth question showed a
trend toward a significant improvement (I feel my thin-
ning hair makes me look less attractive).
None of the Self-Assessment Questions showed any
improvement at Day 90, but three showed a significant
improvement at Day 180 (Table 6), while two
(a)
(b)
(c)
Figure 2 Visible Hair growth in Subject 2. The improvement in
baseline hair appearance (a) is apparent in the 31-year-old Cau-
casian man after twice-daily treatment with the marine complex
formulation for 90 days (b) and 180 days (c). The improvements
in study endpoints for this patient are summarized in Table 4.
5
Marine complex supplement promotes hair growth . G Ablon

Table 4 Changes in Study Endpoints for Subjects 1 and 2

(a)
Baseline Day 90 Day 180

Subject 1
Total hair count 133.0 153.3 160.0
Total hair density 131.0 151.0 157.7
Terminal hair density 96.2 105.0 109.6
Vellus hair density 34.8 46.0 48.1
Subject 2
Total hair count 103.3 117.0 200.8
Total hair density 101.7 115.2 197.8
Terminal hair density 87.7 95.2 154.0
Vellus hair density 14.0 20.0 43.8

questions as well as overall improvement showed a

trend toward a significant improvement. (b)
The investigator assessments of hair qualities showed
significant improvements in three of seven assessments,
including terminal and vellus hair count and terminal
hair density (Table 7). By Day 180, improvement in
vellus hair count was no longer significant, but other
improvements included left and right parietal counts,
total hair count, and total hair density.
The results of the hair pull test were significantly
improved for study drug vs. placebo at Day 90
(P < 0.05) and Day 180 (P < 0.01).

Safety

There were no reports of treatment-emergent adverse (c)

events at any time during the study.

Discussion
Trichoscopy is a useful, noninvasive method for diag-
nosing various skin disorders19,20 including hair loss.21
It is also a useful tool for documenting the response to
treatment.22 TrichoScanTM was developed as a fully
automated method for the measurement of biological
parameters of hair growth such as density, diameter,
and growth rate23 and has been previously used to
assess the patients with androgenetic hair loss24 and
response to treatment.25 Using this method, we were
able to document several significant improvements in
Figure 3 TrichoScan Images for Subject 1. Baseline TrichoScan
hair growth, including total hair count, total hair den- images at baseline (a) and after twice-daily treatment with the
sity, and terminal hair density following twice-daily marine complex formulation for 90 days (b) and 180 days (c).
treatment with the marine complex supplement. These The improvements in study endpoints for this patient are summa-
measures showed a steady improvement from Day 90 rized in Table 4.
to Day 180, suggesting that they may continue to
improve with continued treatment. Future studies the primary endpoints; however, this may have been
should monitor the improvements beyond 180 days. due to the highly variable results for this measure
Improvements in vellus hairs were not observed among including two significant outliers. Nevertheless,

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 Marine complex supplement promotes hair growth . G Ablon

Table 5 Quality of life questionnaire results

(a)
Question Treatment Day 90 Day 180

1. Study Drug P = 0.083

Placebo
2. Study Drug P = 0.045
Placebo
3. Study Drug P = 0.023
Placebo
4. Study Drug P = 0.016 P = 0.05
Placebo
Overall Study Drug P = 0.008 P = 0.016
Placebo

Table 6 Self-assessment questionnaire results

(b)
Question Treatment Day 180

1. Study drug P = 0.096

Placebo
2. Study drug P = 0.038
Placebo
5. Study drug P = 0.073
Placebo
6. Study drug P = 0.05
Placebo
11. Study Drug P = 0.046
Placebo
Overall Study drug P = 0.078
Placebo

(c)
Table 7 Investigator hair assessments

Improved assessments Day 90 Day 180

Right parietal count P = 0.002

Left parietal count P = 0.002
Terminal count P = 0.013 P = 0.036
Vellus count P = 0.013
Total hair count P = 0.036
Total hair Density P = 0.036
Terminal hair density P = 0.024 P = 0.009

These clinical improvements are similar to those pre-

Figure 4 TrichoScan Images for Subject 2. Baseline TrichoScan
images at baseline (a) and after twice-daily treatment with the
marine complex formulation for 90 days (b) and 180 days (c).
The improvements in study endpoints for this patient are summa-
rized in Table 4.
investigator assessments revealed significant improve-
ments in both terminal and vellus hair counts at Day
90 and especially Day 180.
viously reported in women treated with a similar prod-
uct.10,11,13 A recent double-blind, placebo-controlled
clinical study also used trichoscopy to demonstrate a
significant reduction in hair shedding during the first
36 months of daily treatment with the marine com-
plex supplement and a significant increase in the mean
vellus hair diameter after 6 months.12 In addition, the
current study demonstrated the significant improve-
ments in several quality of life measures and subject

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Marine complex supplement promotes hair growth . G Ablon
self-assessments including overall hair growth and hair
volume, hair and nail strength, and overall skin health.
Although nonprescription minoxidil solution is effec-
tive for treating both men and women with thinning
hair,26 it has the disadvantage of requiring twice-daily
topical application. In addition, topical minoxidil does
not provide the systemic benefits of oral marine com-
plex supplements, including improvements in skin and
nails11,13 and improvements in eyebrow growth.10
Prescription medicines such as finasteride have the
disadvantage of potentially serious adverse events.5
The use of marine complex formulations continues
to demonstrate an excellent safety profile. Similar to
previous studies,1013 there were no reports of treat-
ment-emergent adverse events for up to 180 days of
treatment.
Conclusion
The results of this placebo-controlled study show for
the first time that a nutritional supplement containing
a marine complex and other ingredients decreases hair
shedding and promotes hair growth in men with thin-
ning hair, specifically androgenic alopecia. In this era,
patients are looking for simple drug-free options, avoid-
ing the risk factors involved with prescription medica-
tions. This marine complex supplement provides this
optimal opportunity.
Acknowledgments
The author acknowledges the editorial assistance of Dr.
Carl S. Hornfeldt, Apothekon, Inc. This study was
sponsored by Lifes2good, Inc., Chicago, IL.
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