[ORIGINAL RESEARCH]

A Double-blind, Placebo-controlled Study

Evaluating the Efficacy of an Oral Supplement
in Women with Self-perceived Thinning Hair
GLYNIS ABLON, MD, FAAD
Ablon Skin Institute Research Center, Manhattan Beach, California; University of California, Los Angeles, Los Angeles, California

ABSTRACT
Objective: To assess the ability of an oral supplement to increase hair growth in women with thinning hair. Design: A
randomized, placebo-controlled, double-blind study. Setting: One United States clinical site. Participants: Healthy women
aged 21 to 75 years with Fitzpatrick I to IV photo skin types with self-perceived thinning hair. Measurements: Subjects
were randomized to treatment with the study medication (N=10) or placebo (N=5) twice daily for 180 days. A 4cm2 area of
scalp was selected for hair counts performed after 907 and 1807 days of treatment. The primary efficacy measure was
the change in terminal and vellus hairs in each target area. The secondary measure was changes in a self-assessment
questionnaire. Results: The mean (SD) number of terminal vellus hairs among placebo-treated subjects at baseline was
256.0 (24.1), remaining at 245.0 (22.4) and 242.2 (26.9) after 90 and 180 days, respectively. The mean baseline number of
terminal hairs in control-treated subjects was 271.0 (24.2) increasing to 571 (65.7) and 609.6 (66.6) after 90 and 180 days,
respectively (for each, p<0.001 vs. placebo). The mean number of vellus hairs among placebo-and control-treated subjects
did not significantly change. Significantly more control-treated subjects perceived improvements in overall hair volume,
scalp coverage, and thickness of hair body after 90 days. Additional improvement after 180 days included hair shine, skin
moisture retention, and skin smoothness. No adverse events were reported. Conclusion: The oral supplement assessed in
this study safely and effectively promotes significant hair growth in women with temporary hair thinning.
(J Clin Aesthet Dermatol. 2012;5(11):2834.)

A
ndrogenic alopecia or male-pattern baldness is the diminished quality of life among adult men and women with
most common form of hair loss in men and less various forms of hair loss was significantly correlated with
commonly a cause of hair loss in women.1 More symptoms of clinical depression,5 and the psychological
common causes of hair loss in women include medical impact of hair loss among women appears to be more
conditions, such as hypothyroidism; medications including severe than for men.6,7 Consequently, a drug therapy that
oral contraceptives; nutritional deficiencies; and will safely and effectively increase hair growth in women is
physiological and emotional stresses.1,2 The causes of hair highly desirable.
loss in elderly women may be multifactorial.3 Among 100 An oral compound consisting of proteins and
adult women with diffuse hair loss in one study, probable glycosaminoglycans of marine origin was found to have
causes were determined to be psychological stress (30%), beneficial effects on women with sun-damaged skin. The
fever (33%), abortion and delivery (21%), trauma or surgical results of two studies demonstrated improvements in the
operations (13%), and hypothyroidism (10%).4 More than 50 appearance of sun-damaged skin and increased skin
percent of women had more than one likely cause of hair loss thickness and elasticity. Brittle hair and nails returned to
while a cause could not be determined in six percent. normal after 90 days of treatment.8,9 Subsequent studies
The effects of hair loss on self-image and self-esteem assessed the use of a similar marine extract with the
have been well documented. In one study, significantly addition of other natural compounds (Viviscal Hair

DISCLOSURE: Dr. Ablon received a research grant from Lifes2good, Inc., Chicago, Illinois. Funding for this study was provided by Lifes2good, Inc.
ADDRESS CORRESPONDENCE TO: Glynis Ablon, MD, FAAD, Ablon Skin Institute Research Center, 1600 Rosecrans Ave., Manhattan Beach, CA
90266; E-mail: grablon@verizon.net

28 [November 2012 Volume 5 Number 11] 28

 TABLE 1. Self-assessment questionnaire

Please review each of the parameters below and place a check mark (P) for the most appropriate answer.

GREATLY MODERATELY SLIGHTLY SLIGHTLY MODERATELY GREATLY

NO CHANGE
INCREASED INCREASED INCREASED DECREASED DECREASED DECREASED

1. Overall Hair Volume 1o 2o 3o 4o 5o 6o 7o

2. Scalp Coverage 1o 2o 3o 4o 5o 6o 7o

3. Thickness of Hair Body 1o 2o 3o 4o 5o 6o 7o

4. Softness of Hair Body 1o 2o 3o 4o 5o 6o 7o

5. Hair Shine 1o 2o 3o 4o 5o 6o 7o

7o 6o 5o 4o 3o 2o 1o
6. Number of Hairs Lost on
Average Day

7. Nail Strength 1o 2o 3o 4o 5o 6o 7o

8. Nail Growth Rate 1o 2o 3o 4o 5o 6o 7o

9. Skin Moisture Retention 1o 2o 3o 4o 5o 6o 7o

1o 2o 3o 4o 5o 6o 7o
10. Facial Fine Lines and
Wrinkles

11. Skin Softness 1o 2o 3o 4o 5o 6o 7o

12. Skin Resiliency 7o 6o 5o 4o 3o 2o 1o

13. Growth of Eyebrow Hair 1o 2o 3o 4o 5o 6o 7o

14. Growth of Eyelashes 1o 2o 3o 4o 5o 6o 7o

15. Skin Smoothness 1o 2o 3o 4o 5o 6o 7o

16. Overall Skin Health 7o 6o 5o 4o 3o 2o 1o

Nourishment System; Lifes2good, Inc., Chicago, Illinois) for METHODS

the treatment of androgenetic alopecia. Several six-month, Subjects. The study enrolled women 21 to 75 years of
randomized, controlled studies have demonstrated the age with Fitzpatrick skin types I to IV who were in generally
efficacy of Viviscal (the product used in these studies was good health, but complained of self-perceived thinning hair.
originally marketed under the brand name Hairgain Participating subjects expressed their willingness to
[Parexel Medstat AS, Lillestrm, Norway]) for the treatment maintain a consistent shampooing frequency and cut and
of androgenetic alopecia.10 Similar results were achieved in color of their hair and agreed not to substantially change
8- and 12-month, open-label studies11,12 Since these studies their current diet, medications, or exercise routines for the
enrolled men, less is known about the use of Viviscal in duration of the study. Women of childbearing potential were
women with thinning hair. required to use a medically accepted form of birth control
The objective of this randomized, double-blind, placebo- during the study.
controlled study was to test the hypothesis that the Subjects were excluded from participation if they had a
administration of this new oral supplement over a six-month history of allergy or intolerance to fish, seafood, acerola, any
period will increase hair growth in adult women with self- shampoos or hair conditioners; were nursing, pregnant, or
perceived thinning hair associated with poor diet, stress, planning to become pregnant during the study; were
hormonal influences, or abnormal menstrual cycles. participating in another clinical research study; had started
Preliminary results of this study have been presented the use of hormones for birth control or hormone
elsewhere.13 replacement therapy within the prior six months; were

[ November 2012 Volume 5 Number 11] 29

 TABLE 2. Changes in the number terminal and vellus hairs, mean (SD)

STUDY MEDICATION (N=10) PLACEBO (N=5)

Day 0 Day 90 Day 180 Day 0 Day 90 Day 180

Terminal hairs 271.0 (24.2) 571.0 (65.7)a 609.5 (66.6)a 256.0 (24.1) 245.0 (22.4) 242.2 (26.9)

Vellus hairs 46.5 (17.7) 48.0 (16.2) 46.5 (14.4) 57.0 (32.1) 68.0 (21.4) 65.8 (16.6)

a
p<0.0001, each vs. placebo; repeated measures ANOVA

medial canthus, lateral canthus, and preauricular skin pit to

the hairline junction and digitally photographed (Nikkon
SLR 200/300 camera with a Canfield EpiFlash). Following
the baseline visit, subjects returned for evaluation after
907 and 1807 days. At that time, the physical
examination, vital signs, and digital photographs were
repeated. In addition, subjects completed self-assessment
questionnaires (Table 1) and were queried about possible
adverse events.
Test material. Subjects were randomized in double-
blind fashion to receive the new oral supplement (Viviscal
Figure 1. Change in the number of vellus hairs. The use of a new Maximum Strength) or placebo. Viviscal contains
oral supplement was associated with a significant increase in the AminoMar C marine complex, a proprietary blend of shark
number of terminal hairs after 90 and 180 days of treatment. and mollusk powder, an organic form of silica derived from
*Denotes p<0.001 vs. placebo Equisetum sp. (horsetail), vitamin C derived from
Malpighia emarginata (acerola cherry), microcrystalline
cellulose (E460), natural orange flavor, magnesium
currently undergoing a form of treatment for thinning hair stearate, hypromellose, and glycerol. Placebo treatment
including drug or light therapy within the last three months; consisted of inert tablets with similar appearance. Subjects
or used prescription drugs known to affect the hair growth were instructed to take one tablet of their assigned
cycle within the last six months. Subjects with other hair treatment each morning and one tablet each evening with
loss disorders, such as alopecia areata, scarring alopecia, water following a meal.
and androgenetic alopecia; self-reported uncontrolled Efficacy measures. The primary endpoint was the
diseases, such as diabetes, hypertension, hyperthyroidism, change in the number of terminal and vellus hairs in the
or hypothyroidism; self-reported active hepatitis, immune target area of the scalp. The secondary endpoint was the
deficiency, human immunodeficiency virus, or autoimmune change in patient self-assessment questionnaires following
disease; or any known active dermatological condition, treatment (Table 1).
which, in the opinion of the investigator, might place the Safety measures. Safety measures included
subject at a greater risk or interfere with clinical spontaneous reports of adverse events and any adverse
evaluations, were also excluded. events disclosed during clinic evaluations and any changes
Procedures. During the baseline visit, inclusion/ noted during physical examinations.
exclusion criteria were reviewed and each subject provided Statistical analysis. The primary endpoint parameters
informed consent and signed a photography release form. A measured during each evaluation were compared to
medical history was obtained from each subject, baseline data using a paired t-test. Comparisons between
concomitant medications and lifestyle instructions were active and placebo treatments were made using analysis of
reviewed, and each subject underwent a physical variance (ANOVA). Secondary endpoint parameters were
examination and pregnancy testing. The scalp was compared using top box analysis. Differences were
examined to rule out the presence of any confounding scalp considered significant at the level of p0.05.
conditions. The investigator selected an approximately Ethics. This study protocol and informed consent
4cm2 area of scalp along the frontalis bone at the junction of agreement were reviewed and approved by an institutional
the frontal and lateral hairlines. This location was identified review board. Written consent was obtained from all
for further assessments using a three-point location noted participants prior to their participation in any study-related
on each patient according to measurements taken from activities. This study was conducted in accordance with

30 [November 2012 Volume 5 Number 11] 30

 2A 2B

3A 3B

4A 4B
Figures 24. The use of a new oral supplement was associated with a visible increase in hair growth after 90 and 180 days. Figures
2A and 2B = Day 0; Figures 3A and 3B = Day 90; Figures 4A and 4B = Day 180

applicable guidelines for the protection of human subjects 245.0 (22.4) and 242.2 (26.9) after 90 and 180 days,
for research as outlined in the United States Food and Drug respectively (Table 2). In contrast, the mean number of
Administration (FDA) 21 CFR Part 50, with the accepted terminal hairs in the study medication-treated subjects was
standards for Good Clinical Practices and with the standard 271.0 (24.2) at baseline, increasing to 571 (65.7) and 609.6
practices of the Ablon Skin Institute Research Center. (66.6) after 90 and 180 days, respectively (for each,
p<0.001 vs. placebo) (Figure 1). Digital images reveal the
RESULTS visible improvements in two subjects treated with the new
Efficacy. Subjects were randomized to receive the oral supplement (Figures 27).
active medication (N=10) or placebo (N=5). The mean The mean number of vellus hairs among placebo-treated
(SD) age of subjects in the active and placebo treatment subjects was 57.0 (32.1) at baseline and 68.0 (21.4) and
groups were 49.9 (8.5) years and 47.6 (17.0) years, 65.8 (16.6) after 90 and 180 days, respectively (Table 2).
respectively, and were not significantly different from one The mean number of vellus hairs among oral supplement-
another. All subjects described themselves as Caucasian, treated subjects was 46.5 (17.7) at baseline and 48.0 (16.2)
except one who was Hispanic. and 46.5 (14.4) after 90 and 180 days, respectively.
At baseline, the mean number of terminal hairs among With respect to subject self-assessments, significantly
placebo-treated subjects was 256.0 (24.1) and remained at more study medication-treated subjects perceived

[ November 2012 Volume 5 Number 11] 31

5A 5B

6A 6B

7A 7B
Figures 57. The use of a new oral supplement was associated with a visible increase in hair growth after 90 and 180 days. Figures
5A and 5B = Day 0; Figures 6A and 6B = Day 90; Figures 7A and 7B = Day 180

improvements in overall hair volume, scalp coverage, and that Viviscal increases hair growth in women with thinning
thickness of hair body after 90 days (Table 3). Additional hair. These results are in agreement with studies
improvements after 180 days included hair shine, skin demonstrating the drugs beneficial effect in the treatment
moisture retention, and skin smoothness. of sun-damaged skin in women8, 9 and androgenetic alopecia
Safety. No adverse events were reported and no in men.1012
changes were observed during physical examinations. In addition to objective measures of increased hair
growth, significantly more women treated with the study
DISCUSSION medication perceived improvements in overall hair volume
When women with thinning hair were treated with the and thickness and scalp coverage after three months of
study medication, the mean number of terminal hairs in the treatment. Other improvements occurred after three
target scalp area increased from 271.0 at baseline to 571 additional months of treatment including hair shine and
after three months of treatment and increased further to skin smoothness and moisture retention, suggesting
609.6 after six months. Both were significantly greater than additional hair and skin improvements may occur with
the mean number of terminal hairs among placebo-treated continued product use. These results may represent the
subjects at baseline (256.0), which remained unchanged first description of increased hair growth in women
throughout the study. These results support the hypothesis associated with the use of a nutritional supplement. The

32 [November 2012 Volume 5 Number 11]

 TABLE 3. Changes in self-assessment questionnaire, mean (SD)

STUDY MEDICATION (N=10) PLACEBO (N=5)

90 Days 180 Days 90 Days 180 Days

Overall hair volume 2.8 (0.9)a 1.8 (0.8)d 4.2 (0.4) 3.8 (0.4)

Scalp coverage 2.6 (0.8)b 1.5 (0.9)d 4.2 (0.4) 4.0 (0.0)

Thickness of hair body 2.9 (0.7)c 2.0 (0.9)d 4.2 (0.4) 4.0 (0.0)

Hair shine 2.9 (1.1) 2.1 (1.3)e 3.6 (0.9) 3.6 (0.9)

Skin moisture retention 3.6 (0.8) 3.0 (0.8)e 4.0 (0.0) 4.0 (0.0)

Skin smoothness 3.5 (0.7) 3.0 (0.8)e 4.0 (0.0) 4.0 (0.0)

a
p = 0.007, bp = 0.002, cp = 0.003, dp < 0.0001, ep < 0.05, each vs. placebo; ANOVA

results of work by others has demonstrated an oral formation within the hair follicle organ using an ex vivo
supplement containing natural ingredients including culture model. Additional clinical studies designed to
marine-derived protein (shark cartilage) and fish oil further assess the use of Viviscal to increase hair thickness
(omega-3 polyunsaturated fatty acids) significantly and hair counts using larger patient populations are
reduced hair loss in women; however, it did not promote currently under way. Together, these studies will help
hair growth.14 provide a more detailed understanding of the mechanism of
Other natural products, such as biotin and zinc, have this new drug to promote hair growth and add to the
also been advocated for the treatment of hair loss. Biotin is existing body of clinical evidence.
a water-soluble vitamin and an essential coenzyme for
several important enzymes15 while zinc is an essential CONCLUSION
micronutrient that is responsible for the normal functioning The daily administration of a proprietary nutritional
of hundreds of enzymes.16,17 The use of these agents for hair supplement significantly increased hair growth after 90 and
loss is based on the observation that alopecia is one of many 180 days. Self-perceived improvements after 90 days were
consequences associated with biotin15 and zinc increased after 180 days of additional treatment, suggesting
deficiencies.18 In one case report, a child with alopecia due continued improvements may occur with ongoing
to zinc deficiency was administered a zinc supplement and treatment. No adverse events were reported. These results
her hair loss stopped in three weeks18; however, the use of may represent the first description of increased hair growth
a zinc supplement in a group of 15 patients with alopecia in women associated with the use of a nutritional
areata and low serum zinc levels did not result in significant supplement.
hair growth.19 A literature search did not reveal any studies
describing the use of biotin supplementation for the ACKNOWLEDGMENT
treatment of hair loss. Funding for this study was provided by Lifes2good, Inc.,
Iron deficiency is also believed to be a cause of hair loss Chicago, Illinois. The author acknowledges the assistance of
in women, but literature reports are inconsistent. One Dr. Carl Hornfeldt during the preparation of this
report suggests women with iron deficiency status are at a manuscript.
risk of telogen hair loss,20 and among more than 5,000
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34 [November 2012 Volume 5 Number 11]