A Randomized Double-Blind Evaluation of a Novel Biotin and Silicon Ingredient Complex on the Hair and Skin of Healthy Women.

Abstract

Introduction: Age related changes in hair and skin impact quality of life. Interventions to mitigate these changes are of interest.

Aim: To examine the safety and efficacy of LustrivaTM (a novel source of biotin and silicon) at a high or lower dose compared to placebo for impacts on hair and skin.

Materials and Methods: In a randomized, double-blind study, 90 healthy female subjects with self-reported thinning hair who met Savin/Ludwig Scale criteria I-2 to II-1 by physician evaluation were randomized to one of three groups for 12 weeks (n=30/group): LustrivaTM High-Dose (LHD), LustrivaTM Low-Dose (LLD) or Placebo (PL). Hair quality and thickness measured by the TrichoScan HD testing system and skin parameters (facial wrinkles, fine lines, skin texture, skin color evenness, skin elasticity) measured by the Antera 3DTM System and the CutometerTM Dual MPA 580 system.

Results: There was a significant increase in hair thickness measured by change in % vellus hair and % terminal hair and in the ratio of % vellus to terminal hair in LHD compared to PL at Week 3, maintained throughout the study (p=0.029). LHD had a significant decrease in facial wrinkles (12 Weeks) measured by a change in maximal wrinkle depth vs. PL (p=0.031). After 12 weeks compared to baseline LHD significantly improved facial wrinkle Maximum Depth, Indentation Index and Score, facial fine lines Indentation Index and Score, and facial texture Maximum
Height, Roughness and Score (p<0.05), no change in PL. There were no changes for skin elasticity between groups. For some hair and skin parameters, LLD showed improvements less than LHD but that approached significance (p<0.1). All groups improved in subjective nail endpoints vs. baseline with no significant differences between groups. No adverse events reported.

Conclusion: LHD significantly increased hair thickness and reduced facial wrinkle depth compared to placebo and performed better than the LLD in most parameters. Future studies are warranted.

Full text

Journal of Clinical & Experimental
Dermatology Research
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J Clin Exp Dermatol Res, Vol.12 Iss.1 No:551
OPEN ACCESS Freely available online
Research Article
Correspondence to: Susan J Hewlings, Department of Nutrition and Dietetics, The Herbert H & Grace A. Dow College of Health Professions,
Central Michigan University, Michigan, USA, E-mail: hewli1sj@cmich.edu
Received: December 31, 2020; Accepted: January 14, 2021; Published: January 21, 2021
Citation: Kalman DS, Hewlings SJ (2021) A Randomized Double-Blind Evaluation of a Novel Biotin and Silicon Ingredient Complex on the Hair and Skin
of Healthy Women. J Clin Exp Dermatol Res. 12:551.
Copyright: © 2021 Kalman DS, et al. This is an open-access article distributed under the terms of the Creative Commons Attribution License, which
permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.
A Randomized Double-Blind Evaluation of a Novel Biotin and Silicon
Ingredient Complex on the Hair and Skin of Healthy Women
Douglas S Kalman1, Susan J Hewlings2*
1Department of Nutrition, Dr. Kiran C Patel College of Osteopathic Medicine, Nova Southeastern University, Florida, USA; 2Department
of Nutrition and Dietetics, The Herbert H & Grace A. Dow College of Health Professions, Central Michigan University, Michigan, USA
ABSTRACT
Introduction: Age related changes in hair and skin impact quality of life. Interventions to mitigate these changes
are of interest.
Aim: To examine the safety and efficacy of LustrivaTM (a novel source of biotin and silicon) at a high or lower dose
compared to placebo for impacts on hair and skin.
Materials and Methods: In a randomized, double-blind study, 90 healthy female subjects with self-reported thinning
hair who met Savin/Ludwig Scale criteria I-2 to II-1 by physician evaluation were randomized to one of three groups
for 12 weeks (n=30/group): LustrivaTM High-Dose (LHD), LustrivaTM Low-Dose (LLD) or Placebo (PL). Hair quality
and thickness measured by the TrichoScan HD testing system and skin parameters (facial wrinkles, fine lines, skin
texture, skin color evenness, skin elasticity) measured by the Antera 3DTM System and the CutometerTM Dual MPA
580 system.
Results: There was a significant increase in hair thickness measured by change in % vellus hair and % terminal hair
and in the ratio of % vellus to terminal hair in LHD compared to PL at Week 3, maintained throughout the study
(p=0.029). LHD had a significant decrease in facial wrinkles (12 Weeks) measured by a change in maximal wrinkle
depth vs. PL (p=0.031). After 12 weeks compared to baseline LHD significantly improved facial wrinkle Maximum
Depth, Indentation Index and Score, facial fine lines Indentation Index and Score, and facial texture Maximum
Height, Roughness and Score (p<0.05), no change in PL. There were no changes for skin elasticity between groups.
For some hair and skin parameters, LLD showed improvements less than LHD but that approached significance
(p<0.1). All groups improved in subjective nail endpoints vs. baseline with no significant differences between groups.
No adverse events reported.
Conclusion: LHD significantly increased hair thickness and reduced facial wrinkle depth compared to placebo and
performed better than the LLD in most parameters. Future studies are warranted.
Keywords: Dermatology; Hair; Silicon; Biotin
INTRODUCTION
Hair loss, hair thinning, skin wrinkles, and nail brittleness are
common dermatological complaints, with some patients reporting
that these changes negatively impact their quality of life [1]. Hair
loss can be acute or chronic and affects at least 50% of women
by age 50 [2]. Generally, adult women shed 50 to 100 single hairs
per day. While hair shedding is part of the natural hair cycle,
noticeable hair loss is not. It is estimated that more than 50% of
women will experience noticeable hair loss. In fact, female-pattern
hair loss affects at least 30 million women in the United States [3].
It is estimated that the business market size for hair loss products
(pharmaceutical and non-pharmaceutical) is $4 Billion USD, with
the average women spending upwards of $55,000 USD or more in
their lifetime on haircare products [4-6]. The data also reveal that
the health and appearance of nails is important to women. Market
analysis has determined that women spend $8.36 billion a year on
services offered in nail salons [7]. Amongst the reasons products
are purchased in this category are that skin exposure to ultraviolet
light over time may lead to photoaging of the skin and wrinkling

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of the skin. It is interesting to also note that on average, a “Gen-X”
women uses on average six different skin beauty products daily
with an average monthly spend of $42 (˜$504/year) [6,8]. Over a
lifetime, one recent survey found that women will spend $225,360
on products that are intended to improve physical appearance [6].
More than 25 percent of the dollars spent by women on appearance
is directed at facial products (lifetime spend; $51,120) [6]. Thus,
from a financial spend vantage, it is obvious that the appearance of
hair and skin, as well as nails, are of importance.
It is known that the appearance of hair, skin and nails changes
throughout the lifecycle. These changes are due to genetics,
environment, structural changes, and aging, itself [9]. Hair loss can
have a significant psychological impact resulting in symptoms of
depression [10] and diminished quality of life, especially in women
[11,12]. Women and men of all ages can be affected; however,
the thinning presents differently in women in that it is diffuse
[13]. Therefore, interventions to prevent and or mitigate these
conditions are of great interest. Several nutritional interventions
have been suggested including eating a healthy, well-balanced diet
that contains adequate daily intake of vitamins and minerals,
especially trace minerals. Several studies utilizing various vitamin
and mineral supplements to improve brittle nails have been
conducted with mixed results [14,15]. In addition, there has been
increased attention in the literature for non-invasive strategies
for supporting healthy skin and for offsetting some of the signs
associated with photoaging. This has led to research supporting
the role of a healthy, nutrient-rich diet for promoting skin health.
However, exactly what this means and exactly how individual
dietary components contribute is less known [16]. In addition to
a healthy diet, dietary supplements are thought of as a potential
intervention for the appearance of hair, skin or nails. The water-
soluble vitamin Biotin has been shown to play a major role in
the synthesis of protein including keratin, the fibrous protein
that forms the main structural constituent of hair and nails.
It is also a coenzyme for the mitochondrial carboxylases in hair
roots. By supporting the processes of formation of keratin and the
differentiation of epidermal cells in hair and nails, Biotin can help
improve their condition [17,18]. Studies have shown that Biotin
supplementation improves nail thickness and splitting. Silicon is
the third most abundant trace mineral in the human body and
is important for the synthesis of collagen, activating hydroxylation
enzymes, and improving skin strength and elasticity [19]. It has also
been shown to improve hair brightness and to prevent hair loss
[20]. Because of the potential for Biotin and Silicon to improve
common hair, skin and nail conditions and thus improve quality
of life in many consumers, this study aimed to examine the safety
and efficacy of LustrivaTM (a novel compounded dietary ingredient)
at a high or lower dose as compared to placebo for impacts on hair
and skin in otherwise healthy women.
MATERIALS AND METHODS
This study included 90 randomized adult females (21-65 y.o.)
who met the Savin/Ludwig Scale Criteria I-2 to II-1 by physician
evaluation for female hair loss and pattern for inclusion [21-23].
This scale for staging the potential study participant was utilized
because it measures the density and the thickness of the hair,
allowing for classification of the stages of hair loss or change.
Additionally, the study participants verbalized that they were not
happy with the appearance of their hair (self-professed thinning)
or skin (i.e., signs of photodamaged skin) and were interested
in learning if a compound dietary supplement would make any
differences in their hair or skin appearance. Subjects had to meet a
strict inclusion and exclusion criteria for enrollment.
Study inclusion criteria included
• Adult females aged 21 to 65 years of age inclusively at the time
of screening, who were not happy with the appearance of either
their hair or skin (i.e., signs of damaged hair or photodamaged
skin) but were otherwise healthy and stated that they had self-
professed thinning of the hair.
• The Principal Investigator (PI) confirmed that subject qualified
for the study by meeting the Savin/Ludwig Scale Criteria I-2
to II-1 for entry.
• In good health and assessed as eligible by screening blood
pressure, screening heart rate, screening blood test for
metabolic panel, CBC with differential, physical exam, and by
medical plus surgical history per the PI.
• Agreed to maintain a stable lifestyle with no change in exercise
or diet for the duration of the study.
• Agreed to maintain a consistent shampooing frequency, same
shampoo and conditioner (as applicable), and cut and color of
their hair for the duration of the study, as long as the cut/color
did not include the area of TrichoScan HD analysis (near the
crown of the head).
• Agreed to provide a detailed list of all facial cosmetic products
(including night creams, lotions, facewashes, etc.) that they
were using daily or frequently and not to change this regimen
for the duration of the study.
• Agreed to avoid all tanning (sun or artificial such as tanning
beds, sprays and other topical applications) and sun burning
for the entire duration of the study and confirmed avoiding
them 2 weeks prior to screening. If it happened accidentally,
it had to be documented in the source documentation and
the CRF.
• Agreed not to utilize any new over the counter, commercial
or other products that were marketed and promoted for
enhancing aspects of their hair or skin (e.g., ViviscalTM,
BioSilTM, NutrafolTM, etc.) for the entire duration of the
study and confirmed not using them one month prior to the
screening visit.
• Were able to refrain from strenuous exercise/activity for at
least 24 hours prior to each visit. Able to refrain from alcohol
(or alcohol-containing beverages and foods) consumption for
at least 24 hours prior to each visit.
• Agreed to refrain from taking any vitamins or dietary/herbal
supplements containing silicon or biotin for at least 7 days
prior to the baseline visit and throughout the study, except for
the study product.
• Subjects agreed on the visit days to refrain from using lotions,
creams, makeup, or other products on their face until after
completion of the study visit assessments.
Objective measurements
Skin measurement: The skin appearance of wrinkles, scars,
redness, pigmentation, texture and skin color were evaluated on

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Subjects were instructed to consume one capsule daily.
2. Low-dose LustrivaTM: Comprised of 146.5 mg inositol-
stabilized arginine silicate (ASI) with 3.5 mg magnesium
biotinate providing 10 mg silicon and 3 mg biotin and inactive
ingredients: Dicalcium phosphate (Dihydrate), silicon dioxide,
magnesium stearate, gelatin and titanium dioxide. Subjects
were instructed to consume one capsule daily.
3. Placebo (inactive ingredients: Dicalcium phosphate
(Dihydrate), silicon dioxide, magnesium stearate, gelatin and
titanium dioxide). Subjects were instructed to consume one
capsule daily.
4. The study product and placebo were supplied by JDS
Therapeutics, Harrison, NY.
5. The participants and the Investigator/study staff who
conducted the study procedures were blinded by packing the
study products that had the same appearance into identical
DispillTM blister packs.
Statistical methods and approach
As this study was exploratory in nature, the sample size was
considered a convenience sample of 90 randomized subjects, given
30 per group (n=30 low-dose LustrivaTM; n=30 high-dose LustrivaTM
and n=30 placebo). For analysis, the study employed Full Analysis
Set (FAS) for any efficacy evaluation. A Full Analysis Set included
all randomized subjects who have received at least one dose of study
product and have at least one baseline efficacy assessment and one
post-baseline efficacy assessment.
A Per Protocol Analysis is considered a sub-analysis of the FAS
dataset. A Per Protocol analysis was also undertaken (analysis of
the data for those subjects who started and completed the study
with all data being accounted for).
For determination of safety, all subjects who received at least one
dose of the study product were included in the safety analysis.
For the continuous dependent variables, paired t-test or Wilcoxon
signed rank test was used to determine the significance of change
from baseline within each group depending on whether or not the
data was normally distributed. The analysis of variance (ANOVA)
or Kruskal-Wallis test was applied to compare the change from
baseline among the low-dose group, high-dose group, and placebo
group depending on normality distribution and variance structures
of three groups. The same analysis (ANOVA) was applied to percent
change from baseline, together with summary.
For categorical dependent variables, chi-square test or Fisher’s exact
test was applied to compare the difference in proportion among
the three groups.
In addition, the analysis of covariance (ANCOVA) model was
applied to analyze the efficacy endpoint, with the change from
baseline as the response variable, treatment, visit, the interaction
of treatment and visit as fixed effect, and finally, the baseline
score as a covariate. Based on the model, the overall least squares
means (LS Means) for low dose group, high-dose group, combined
treatment group, and placebo group was calculated, together with
95% confidence interval. The differences in overall LS Means
between the low-dose group and placebo group, high-dose group
and placebo group, combined non-placebo group and placebo
group, and low-dose group and high-dose group, was calculated,
together with 95% confidence interval. Furthermore, the similar
the Antera 3DTM System. Briefly, the Antera 3DTM system is a
validated objective system for determining changes in the skin. An
Antera 3D evaluation of wrinkles, scars, redness, pigmentation,
texture and skin color was completed at baseline and throughout
the study period (over a 12-week period, measuring changes from
baseline). This diagnostic tool utilizes a technology related to
shape from shading, photometric stereo measurements, with the
aim to reconstruct the skin in 3D thanks to multiple images taken
under different light sources with 7 different wavelengths spanning
most of the visible spectrum [24,25]. The software automatically
calculates the objective outcome measures.
Skin elasticity was measured by using the CutometerTM Dual MPA
580TM system. Per the manufacturer, the measuring principle of
the CutometerTM is based on the suction method, where negative
pressure deforms the skin mechanically. The pressure is created in
the device and draws the skin into the aperture of the probe and
after a defined time, releases it again [26].
Hair analysis: Evaluation of changes in hair was conducted by using
the TrichoScan HD system. The TrichoScan HD testing system is
a computerized method to determine hair density and the status
of hair roots of scalp hair. It calculates responses to treatment in
patients (study subjects) [27,28]. In order to conduct the procedure,
a small concealed portion of the subject’s hair was clipped with an
electric clipper; care was taken that the hair clipped was even and not
too short. Next, the optical contact plate that had a LED light-ring
to ensure proper lighting was pressed firmly onto the scalp, also, an
alcoholic disinfection spray was used to enhance the optical plate.
This helped the hair lay flat onto the scalp and ensured that the
image was taken at the same distance from scalp. Next, the image
was taken by a camera that was completely controlled by software
that ensured settings like zoom, contrast, resolution, compression,
and others were the same from image to image. Measurements were
conducted by a trained professional per the user manual who was
aware of the technical requirements like contrast, lightening and
ensuring no air bubbles and no hair dye remnants. Hair dyes were
used to enhance contrast for white, grey, or fair hairs, if deemed
appropriate [29].
Photographic system: A NikonTM D5300 with a TAMRON Model
F017 lens was used to obtain photographs of the frontal face,
crown, facial profile (left side of the participant), and back of the
head. All photographs were taken in the same location with same
lighting without using flash or portrait mode. Frontal face and
profile photographs were captured from bottom of the chin to
top of the head at resting face position without smile. The crown
photograph was taken with the natural hair part either down the
middle or side from a frontal view, facing the subject. Back of the
head photograph (with hair down) was also taken. For the frontal,
crown, and profile photographs, all the identifying features (eyes,
nose, mouth, ears, birth marks, moles, and scars) were de-identified
per standard operating procedures of the clinic (QPS-Missouri,
Springfield, MO) and the study Sponsor (JDS Therapeutics,
Harrison, NY).
Study products
1. High-dose LustrivaTM: Comprised of 146.5 mg inositol-
stabilized Arginine Silicate (ASI) with 11.7 mg magnesium
biotinate providing 10 mg silicon and 10 mg of biotin and
inactive ingredients: Dicalcium phosphate (Dihydrate), silicon
dioxide, magnesium stearate, gelatin and titanium dioxide.

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LS Means and difference in LS Means for different visits was also
calculated.
Institutional Approval-This study was executed by the research site
and company QPS. Specifically, The QPS-Missouri (Springfield,
MO) clinical site executed and conducted this study with the IRB
approval by the Bio-Kinetic Clinical Applications on October
28, 2019 and study oversight by Nutrasource (Guelph, Ontario,
Canada).
RESULTS
Screening and enrollment
161 subjects were screened for this study. Of the 161 screened 90
subjects were deemed eligible and randomized. Eight-nine (89)
subjects out of the 90 enrolled were included in Full Analysis.
The Safety study population included all 90 subjects that were
randomized. The Per Protocol analysis was carried out on 88
subjects (two subjects in the placebo group did not finish the
study, one which was lost-to-follow-up and the second person
discontinued due to an unrelated serious adverse event).
Demographics
The 90 subjects enrolled were all female, 46.9 ± 11.69 years of age,
and predominately Caucasian (86 of the 90 subjects), with three
African Americans and one American Indian participant (90
total). Subjects had a mean height of 165.4 ± 6.00 cm and a body
weight of 76.99 ± 12.6 kg. The corresponding body mass index for
the overall participants was 28.17 kg/m2.
Skin parameters
Facial skin wrinkles: Both the Lustriva HD and the Lustriva LD
groups experienced significant improvement in the Wrinkles
Indentation Index from baseline to Week 3 (~day 21) [Lustriva
HD=-0.367 (0.1779), p=0.0405; Lustriva LD=-0.417 (0.1779),
p=0.0202], while the PL group experienced no change. By the
end of the study (day 84), only the Lustriva HD group achieved
significant improvement in the maximal wrinkle depth [Lustriva
HD=-7.0 (2.9), p=0.0253], whereas the other groups did not
experience such a change (p>0.05). Additionally, the results (by
t-test) from the Antera 3DTM system tests indicated a significant
improvement in maximum depth of wrinkles from baseline to Visit
5 (end of study visit) in Lustriva HD [-8.0 (18.9)], when compared
with Placebo [1.0 (12.1)], p=0.031. Lustriva HD over 12-weeks had
the greatest impact on facial wrinkle indentation index (Figures 1
Facial fine and overall fine lines: Both the Lustriva HD and
Lustriva LD demonstrated statistically significant improvements
in the facial fine lines score over the course of the study, whereas
the PL group did not [Lustriva HD=-0.216 (0.0854), p=0.0124 and
Lustriva LD=-0.222 (0.0853), p=0.0099]. The improvement for
the Lustriva HD and the Lustriva LD was also significant for the
overall fine lines score [Lustriva HD=-1.473 (0.5766), p=0.0115 and
Lustriva LD=-1.412 (0.5756), p=0.0152], which was not significant
for the placebo group (p>0.05).
Skin texture: For skin texture (maximum height), the Lustriva HD
experienced a significant improvement over the course of the study,
[(day 84) Lustriva HD=-0.008 (0.0036), p=0.0239], which was not
true for the Lustriva HD or Placebo groups (p>0.05). Additionally,
the Lustriva HD group had significant improvement in skin texture
roughness by study visit 3 [(day 21), Lustriva HD=-0.504 (0.1894),
p=0.0085], which was maintained for the duration of the study
[(day 84) Lustriva HD=-0.705 (0.2558), p=0.0065]. Lustriva LD
and Placebo did not achieve significant changes for this outcome
parameter.
Other skin parameters: For skin color, overall the data for between
group differences, over the course of the study, the Lustriva LD
was found to be significantly better than the placebo [C=0.075
(0.0326), p=0.0072]. There were no remarkable changes noted for
skin elasticity between any of the groups.
Nails: All groups improved vs. baseline in the three subjective nail
endpoints (appearance, strength, and growth) measured by Likert
scales though there were no significant differences between groups.
Hair parameters: Changes in hair growth, turnover and health
were evaluated by the TrichoScan HD. Changes in percent vellus
and percent terminal hair (and the ratio of the two) were of study
interest. There was a significant change in % vellus hair and %
terminal hair ratio as well as in the ratio of % vellus to terminal
hair in the Lustriva HD group as compared to Placebo by Week
3 (day 21) and remained significant at Week 12 (p=0.029). Over
the course of the study, the Lustriva HD group outperformed the
PL group for change in vellus hair [Lustriva HD=-13.18 ± 15.28
vs.-5.73 ± 9.32; p=0.029], there were no differences between the
Lustriva LD and PL for this outcome (p>0.05) (Figures 3 and 4).
Safety: This study did have one Serious Adverse Event (SAE).
The SAE occurred in the Placebo group and was deemed by the
study physician to be unrelated to the study. There were no safety
concerns regarding the Lustriva HD or the Lustriva LD or the
Placebo groups as all safety monitoring signals remained within
and 2).
Figure 1: Clinical image of change in facial wrinkles maximum depth (µM)
at week 12.
Figure 2: Change in facial wrinkles maximum depth (µM) at week 12
(± standard error). Change from baseline P-values for placebo, Lustriva
LD, and Lustriva HD are respectively 0.325, 0.653, 0.023. *Lustrivia HD
P-value=0.031 vs. placebo.

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clinically normal values (comprehensive metabolic panel, complete
blood count with differential, monitoring of blood pressure and
related items).
DISCUSSION
This study evaluated the impacts of two different doses of
a commercial compound novel dietary supplement chiefly
comprised of inositol-stabilized Arginine Silicate (ASI) and
magnesium biotinate. This novel compound dietary supplement
provides arginine, silicon, magnesium and biotin to the end user.
In pre-clinical testing and evaluation, the tested dietary supplement
was able to achieve significant improvement in skin protection
(appearance and elasticity) against photoaging (rodent ultraviolet
radiation model) as compared to placebo [30]. The product tested
in this human trial, was also evaluated in a pre-clinical rodent model
for potential efficacy in hair and nail growth. In the pre-clinical
study, it was found that the unique dietary supplement promoted
significant positive changes in hair growth and hair density, while
also supporting nail growth [30]. The two pre-clinical studies
yielded signals of follow-up in a human model. In this clinical
study, impaired nails were not one of the entry criteria which
may explain why all groups saw improvements vs. baseline though
there were no significant differences between groups. Arginine by
itself is known to be a vasodilator and positive promoter of nitric
oxide production. L-arginine is the substrate for the enzyme Nitric
Oxide Synthase (NOS), which is responsible for the endothelial
production of nitric oxide [29]. Dietary supplementation with
L-arginine has been shown to have human health benefits,
including significantly improving endothelial function in
individuals even without vascular disease (healthy subjects) [31].
Blood flow to the skin is neurally controlled by the adrenergic
vasoconstrictor system and an active vasodilator system [32]. The
vasodilator pathways mediate downstream nitric oxide dependent
vasodilatation, which is needed for the full reflex vasodilatory
response in humans, the nutritional driver of NO production is
the amino acid arginine [33]. The form of arginine used in this
study (inositol stabilized arginine silicate) has been shown to
significantly enhance blood flow velocity, which can be secondary
to improved vasodilation [34]. Understanding that L-arginine is
the common substrate for both Nitric Oxide Synthase (NOS) and
arginase is important, as arginase also catalyzes the conversion or
arginine to urea and ornithine, which is the precursor to proline.
Proline has importance in skin and other tissue integrity, especially
for collagen synthesis [35]. Arginine, in addition to being able to
be converted into proline, also can be incorporated into collagen
itself [36]. The arginine-derived nitric oxide and arginine itself is
said to have an important role in the overall health and appearance
of skin, though this has not been well-tested in terms of outcomes
(i.e., can arginine supplementation have a positive impact on the
appearance of skin), hence this study evaluated the question [37].
In this study, there were noticeable significant changes in aspects of
facial skin appearance with a significant reduction in facial wrinkles
and wrinkle depth, fine lines, skin texture and skin roughness
most consistently for the Lustriva HD product. While there were
no signs, symptoms or overt concerns regarding any nutrient
deficiency or insufficiency in the diets of the study participants, it
is wholly possible by the mechanism of action of how Lustriva HD
works, that the enhanced blood flow and greater nutrient delivery
translated to better appearing skin (by objective measurements).
Within the ingredients of the Lustriva HD and LD product is
magnesium biotinate. Magnesium biotinate has been shown to be
40 times more soluble than biotin alone and has been patented as
WIPO Number WO2018045244A1 with the US Patent number
of 2017049757 W 20170831. A recent pharmacokinetic study
demonstrated that this version of biotin is also well absorbed in
a dose dependent manner in humans [38]. Biotin plays a role in
many metabolic pathways in the body and it is an essential dietary
cofactor for mammalian carboxylase enzymes [39]. In short,
biotin is a water-soluble vitamin that participates as a cofactor in
gluconeogenesis, fatty acid synthesis and branched chain amino
acid catabolism. Biotin functions as the carboxyl carrier for biotin-
dependent carboxylases. Its covalent attachment to carboxylases is
catalyzed by holocarboxylase synthetase. Biotin deficiency is rare.
Biotin as a dietary supplement for normal healthy people without
deficiency or any inborn error of metabolism on its own may
not be an ergogenic aid for hair health or skin health. However,
within the confines of this study, the biotin-containing compound
nutritional product did demonstrate benefits over placebo for
objective outcomes as related both to facial skin appearance and
hair growth. Studies utilizing biotin supplementation alone for
hair loss secondary to a laparoscopic sleeve gastrectomy (over
a one-year period) provided mixed results with the conclusion
indicating biotin on its own has low efficacy to prevent hair loss
[40]. Interestingly enough, a recent survey study found that 43.9%
of physicians prescribe biotin primarily for hair or nail disorders,
which is an indictor and barometer of physician’s standards of
care for their patients [41]. The biotin form utilized as part of the
study compounded nutritional product (LustrivaTM) is a novel one
in that it is magnesium biotinate. This means that magnesium is
also being delivered to the body upon ingestion. It is interesting
to note that magnesium is one of the mineral elements that as we
age, it appears to be in greater concentrations in the hair (meaning
Figure 3: Clinical image of terminal hair between baseline and week 12.
Figure 4: Change in percent terminal hair between baseline and week 12
(± standard error). Change from baseline P-values for Placebo, Lustriva
LD, and Lustriva HD are respectively 0.002, 0.008, <0.001. *Lustrivia
HD P-value=0.029 vs. placebo.

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excretion of calcium into hair increases as we age past 20 to 25)
[42]. The National Health and Nutrition Examination Survey
(NHANES) revealed that much of the United States does not
consume adequate amounts of magnesium. The median intake of
magnesium in the diet was 326 mg/d for Caucasians, 237 mg/d for
African Americans and 297 mg/d for Mexican American men. For
women, the median intake was 237 mg/d for Caucasians, 177 mg/d
for African Americans and 221 mg/d for Mexican Americans. All
of these amounts are below the daily recommended allowance for
magnesium (males: 400 to 420 mg/d and females: 310 to 320 mg/d
for those aged 19-30 and 31 to 51+) [43]. Hence, it can be stated
that the nutritional compound product which was evaluated in
this study may have ameliorated some of the vitamin or mineral
insufficiency in the diets of the study participants.
CONCLUSION
In conclusion, there were statistically significant between group
changes in the Lustriva HD group compared to placebo for facial
wrinkles using the Antera 3DTM system and % vellus and %
terminal hair, as well as for the ratio of percent vellus to terminal
hair, as tested via the TrichoScan HD system. The Lustriva HD
group overall appeared to perform better than the Lustriva LD
group as compared to Placebo in most of the study parameters. In
this study, the test products, Lustriva HD and Lustriva LD, have
shown statistical significance over the placebo for hair and skin
endpoints with no safety concerns.
ACKNOWLEDGEMENT
Funding for the study provided by JDS Therapeutics, Harrison NY.
DISCLOSURE
The authors are employees of Nutrasource, the CRO that oversaw
the study.
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