Efficacy and Safety of a Food Supplement Containing L-cystine, Serenoa repens Extract and Biotin for Hair Loss in Healthy Males and Females. A Prospective, Randomized, Double-blinded, Controlled Clinical Trial

Abstract

Background: Hair loss in both men and women can be a psychologically stressful condition. Dietary insufficiency of essential micronutrients has been associated with hair health and hair loss.
Objective: The aim of this clinical trial was to investigate the safety of use and the efficacy of a food supplement containing L-cystine, Serenoa repens, Equisetum extract, zinc, and vitamins (Lambdapil® Anti Hair Loss capsules, ISDIN, Provençals, Barcelona, Spain) in improving hair loss in both women and men.
Patients/Methods: Men with androgenic alopecia and women with acute telogen effluvium were randomized to receive two capsules per day of the test product or the placebo product during a 6 months treatment period. Hair resistance to pulling and count were measured in women and men, respectively, by pull testing and phototrichogram. The overall hair volume and overall hair appearance were assessed before and after the treatment as were subject’s self-assessment via a standardized questionnaire.
Results: In women, the number of hairs removed in the pull test decreased earlier for test product treated group over the 6-month period with a significantly greater decrease (p<0.05) for the treated group (12.9 at baseline vs. 6.5 hairs at 6 M) compared to the placebo group (12.8 at baseline vs. 8.8 hairs at 6 M). For men, the anagen/telogen ratio increased in the Lambdapil® treated group by 22.3% over baseline (1.93 vs. 2.36 at baseline and 6 M, respectively) indicating that there were more hair in the growing phase vs. placebo treated group (1.81 vs 1.75 at baseline and 6 M, respectively; p<0.05). The hair volume and aspect in Lambdapil® treated group improved at 1, 3 and 6 months significantly more than placebo group (p<0.05). The treatment was well tolerated.
Conclusion: Dietary supplementation with Lambdapil® Anti Hair Loss capsules for 6-months was safe and effective in both women and men suffering from hair loss.

Full text

Efficacy and Safety of a Food Supplement Containing L-cystine,
Serenoa
repens
Extract and Biotin for Hair Loss in Healthy Males and Females. A
Prospective, Randomized, Double-blinded, Controlled Clinical Trial
Mridvika Narda1*, Sonia Aladren1, Enza Cestone2 and Vincenzo Nobile2
1ISDIN SA, ISDIN Medical Department, Provencals 33, 08019 Barcelona, Spain
2Complife Italia Srl, Via Mons Angelini 21, 27028 San Martino Siccomario (PV), Italy
*Corresponding author: Mridvika Narda, ISDIN SA, ISDIN Medical Department, Provencals 33, 08019 Barcelona, Spain, E-mail: mridvika.narda@isdin.com
Received date: November 07, 2017; Accepted date: November 29, 2017; Published date: November 30, 2017
Copyright: © 2017 Narda M, 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.
Abstract
Background: Hair loss in both men and women can be a psychologically stressful condition. Dietary insufficiency
of essential micronutrients has been associated with hair health and hair loss.
Objective: The aim of this clinical trial was to investigate the safety of use and the efficacy of a food supplement
containing L-cystine, Serenoa repens, Equisetum extract, zinc, and vitamins (Lambdapil® Anti Hair Loss capsules,
ISDIN, Provençals, Barcelona, Spain) in improving hair loss in both women and men.
Patients/Methods: Men with androgenic alopecia and women with acute telogen effluvium were randomized to
receive two capsules per day of the test product or the placebo product during a 6 months treatment period. Hair
resistance to pulling and count were measured in women and men, respectively, by pull testing and
phototrichogram. The overall hair volume and overall hair appearance were assessed before and after the treatment
as were subject’s self-assessment via a standardized questionnaire.
Results: In women, the number of hairs removed in the pull test decreased earlier for test product treated group
over the 6-month period with a significantly greater decrease (p<0.05) for the treated group (12.9 at baseline vs. 6.5
hairs at 6 M) compared to the placebo group (12.8 at baseline vs. 8.8 hairs at 6 M). For men, the anagen/telogen
ratio increased in the Lambdapil® treated group by 22.3% over baseline (1.93 vs. 2.36 at baseline and 6 M,
respectively) indicating that there were more hair in the growing phase vs. placebo treated group (1.81 vs 1.75 at
baseline and 6 M, respectively; p<0.05). The hair volume and aspect in Lambdapil® treated group improved at 1, 3
and 6 months significantly more than placebo group (p<0.05). The treatment was well tolerated.
Conclusion: Dietary supplementation with Lambdapil® Anti Hair Loss capsules for 6-months was safe and
effective in both women and men suffering from hair loss.
Keywords: Hair loss; Androgenic alopecia; Acute telogen euvium;
L-cystine;
Serenoa repens
; Biotin
Introduction
Hair loss, represented by acute Telogen Euvium (aTE) in women
and androgenetic Alopecia (AGA) in men, is a frequent reason for
dermatology consultation. Despite their being benign and mild
conditions, the associated psycho-emotional stress may impact the
subjects quality of life, and may sometimes lead to secondary
morbidity [1-3]. e main factors contributing to psycho-emotional
stress are inability to style hair, dissatisfaction with appearance,
concern about the continuing hair loss and concern about others
noticing hair loss [4].
Telogen Euvium (TE) is an increased loss of normal club hairs
that occurs by a perturbation of the hair cycle [5]. Whatever the cause
of hair loss, it results in increased disruption of hair cycle leading to
synchronized telogen shedding. It can occur in both genders, but is
overrepresented in women [6]. aTE was rst described as an acute
onset scalp hair loss occurring 2-3 months aer a triggering event,
which is unidentiable in up to 33% cases [6]. A number of factors
have been implicated in the causation of TE, including high fever,
surgery, hospitalization, hemorrhage, changes in medication,
postpartum emotional stress, seasonal variation (July to October),
changes in medication and heavy metals. However, clear evidence in
their support is lacking [6].
Androgenic alopecia (AGA) is the most common hair loss disorder
[6]. It is characterized by the miniaturization of the large, thick
pigmented terminal hair with a diameter of >0.03 mm to small, ne,
non-pigmented vellus hair with a diameter of ≤ 0.03 mm [7]. In most
men, AGA develops with a distinctive "patterned" hair-line recession
[8-10]. It aects 50% of male by the age of 50 years and up to 70% of all
males in the later life [10]. It is caused by the overproduction of 5a-
dihydrotestosterone (5a-DHT), a potent androgen, within the hair
follicle, specically the dermal papilla cells that are the main regulators
of hair growth and are the site of 5a-DHT action [10]. It occurs aer
puberty in men with an inherent sensitivity to the eects of androgens
on androgenetic sensitive scalp hair follicles. It does not develop in
men without testosterone or in men with a genetic deciency of the
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ISSN: 2471-9323
Journal of Cosmetology & Trichology Narda et al., J Cosmo Trichol 2017, 3:3
DOI: 10.4172/2471-9323.1000127
Research Article Open Access
J Cosmo Trichol, an open access journal
ISSN:2471-9323
Volume 3 • Issue 3 • 127

enzyme 5-alpha-reductase type II which converts testosterone to DHT
[6].
Currently two active pharmacological ingredients are approved by
the US Food and Drug Administration (FDA) for the treatment of
AGA, nasteride and minoxidil. Finasteride acts by inhibiting 5-alpha-
reductase and minoxidil, a potassium channel opener, hypothetically,
acts by widening blood vessels and opening potassium channels, thus
allowing more oxygen, blood, and nutrients to the follicles. Although
both have demonstrated ecacy for the treatment of androgenic
alopecia in men [6], both drugs have side eects and are eective in
less than 50% of the patients. Moreover, some people are intimidated
by the pharmacological approach to treat a non-life-threatening
disease such as alopecia. Food supplements are a non-pharmacological
approach that is easy to t into everyday routine without signicant
side eects to treating this sometimes emotionally taxing condition.
In the present study we tested the ecacy of dietary supplements in
capsule form (Lambdapil® Anti Hair Loss capsules, henceforth
Lambdapil®; currently marketed by Isdin, Spain) containing a unique
combination of plant extracts:
Serenoa repens
extract,
Equisetum
arvense
extract, essential minerals: zinc, vitamins: B3, B5, B6, D-biotin
and amino acids: L-cystine and taurine in improving the signs of
alopecia in both men and women.
Serenoa repens
extract has been
reported to inhibit 5-alpha reductase activity, an enzyme involved in
the hair loss in alopecia [8].
Equisetum arvense
is a plant rich in highly
bioavailable silicon which is purported to aid in improving the
resilience of hair and nails [9]. Other components of the capsules such
as biotin, zinc, amino acids and vitamins are thought to contribute to
the maintenance of normal hair by normalizing protein synthesis
including keratin and collagen synthesis which is essential for hair
growth [11]. Vitamin B6 has been described to contribute to the
regulation of hormonal activity [12]. is combination of plant
extracts, vitamins, trace minerals and amino acids has been designed
to replenish these where a possible deciency might have led to a hair
loss and regulating the hormonal balance to favor hair growth.
e primary objective of this randomized, double-blind, placebo-
controlled study was to assess the ecacy of Lambdapil® capsules in
decreasing the clinical signs of hair loss in female and male subjects.
Materials and Methods
Study design
is monocentric, prospective, randomized, parallel-group, double-
blind, placebo controlled study was carried out in accordance with the
Declaration of Helsinki and the Good Clinical Practice guidelines E6
(R1). e study protocol and the informed consent form were
approved by the “Independent Ethical Committee for Non-
Pharmacological Clinical trials” during its meeting on February 06 th,
2014. is study was not registered as the tested product was a food
supplement. All subjects provided written informed consent and a
consent release for photo publication before initiation of any study-
related procedures. e study took place at Farcoderm s.r.l.
dermatological facilities in San Martino Siccomario (PV), Italy.
Farcoderm s.r.l. is an independent testing laboratory for
in vitro
and
in
vivo
safety and ecacy assessment of cosmetics, food supplements and
medical devices.
Subjects
Eligible subjects were enrolled and screened in the study under the
supervision of a board certied dermatologist. All subjects were adult
Caucasian male and females subjects aged between 18 and 65 years old
showing the clinical signs of AGA grade II to III vertex according to
Hamilton Norwood scale [13] or aTE, respectively. e participants
were enrolled (recruitment and treatment) between March and
September 2014. e inclusion criteria were as follows: i) adequate rest
period between two similar study (at least 6 months from the last
study), ii) willingness to not use products for hair care (both topic and
systemic) likely to interfere with the product to be tested, iii)
willingness to not use, during all the study period, products for hair
care other than the products supplied, iv) willingness to not vary the
normal daily routine (i.e. lifestyle, physical activity, including haircut,
etc.), v) subject under eective contraception (oral/not oral); not
expected to be changed during the trial. Exclusion criteria included
pregnancy or intention to become pregnant, lactation, food
intolerances/allergy, and participation in another similar study within
6 months prior to enrolling in the study, subjects unwilling or unable
to comply with the requirements of the study protocol. e study
further excluded subjects using topical products or food supplements
containing actives that could have an inuence on hair physiology.
Changes in hairstyle or dyeing of the hair were not allowed during the
trial.
Interventions
e tested product was a commercially available food supplement
named Lambdapil® capsules (ISDIN, Provençals, Barcelona, Spain).
e product composition is presented in Table 1. e placebo product
was a 100% maltodextrin capsule. Active and placebo products were
identical in appearance without any visible dierence. Subjects were
instructed to take both the active and the placebo products as follows:
2 capsules a day in the morning at breakfast, to be swallowed as a
whole with plenty of water. For the duration of the study period,
subjects washed their hair using a neutral shampoo.
Components Per 2 capsules %NRV* (2
capsules)
L-Cystine 1000 mg -
Serenoa repens 100 mg -
Equisetum arvense L. 7.14 mg -
Silicon 0.50 mg -
Zinc (zinc sulphate) 10 mg 100%
Vitamin B3 (nicotinamide) 16 mg 100%
Vitamin B5 (calcium D-
pantothenate)
6 mg 100%
Vitamin B6 (pyridoxine
hydrochloride)
1.4 mg 100%
D-biotin 50 µg 100%
Taurine 40 mg -
*Nutrient reference Value
Table 1: Product Composition.
Citation: Narda M, Aladren S, Cestone E, Nobile V (2017) Efficacy and Safety of a Food Supplement Containing L-cystine, Serenoa repens
Extract and Biotin for Hair Loss in Healthy Males and Females. A Prospective, Randomized, Double-blinded, Controlled Clinical Trial. J
Cosmo Trichol 3: 127. doi:10.4172/2471-9323.1000127
Page 2 of 8
J Cosmo Trichol, an open access journal
ISSN:2471-9323
Volume 3 • Issue 3 • 127

Endpoints
e primary outcome measured was the hair loss aer pull testing
for female subjects with aTE and the anagen/telogen hair ratio for male
subjects with AGA. All measurements were carried out on cleansed
hair (1 day before the visit) under temperature (22 ± 2°C) and
humidity (50 ± 10%) controlled conditions. Pull test (in female
subjects) consisted in a gentle traction exerted on a cluster of hair
(approximately 60 hairs) on three dierent areas of the scalp (frontal,
temporal, and occipital), and the number of hairs was counted.
Normally, less than three telogen-phase hairs should come out with
each pull. If at least three hairs were obtained with each pull or if more
than ten hairs total were obtained, the pull test was considered positive
and suggestive of telogen euvium.
For phototrichogram procedure (in male subjects), a transitional
area (1.8 cm²) of hair loss between normal hair and the balding area
was dened using a stencil template and chosen for clipping. e
clipped hairs within the target area were dyed for gray or fair hairs with
a commercially available solution (RefectoCil®, GW Cosmetics GmbH,
Leopoldsdorf, Germany) in order to enhance their contrast. ereaer,
the dyed hairs were cleansed using an alcoholic solution. Digital
macrophotographs were taken using a Nikon D300 reex camera
digital camera (Nikon Corporation Tokyo, Japan) equipped with a
macro objective (AF-S Micro NIKKOR 60 mm f/2.8G ED, Nikon
Corporation Tokyo, Japan), an independent ash system (Kit R1C1,
Nikon Corporation Tokyo, Japan) and cross-and parallel-polarized
lters. Digital macrophotographs were taken at the time of clipping (0
h) and 48 aerwards (48 h). e resulting images were analyzed by
using NIH soware. Aer identifying the same hairs in the images
taken at 0 h and 48 h following the clipping for all the experimental
monitored times, the length of each hair was measured and the
number of hair in the clipped area were counted. is allowed for the
calculation of the anagen (growing)/telogen (not growing) hair ratio.
e overall hair volume and overall hair appearance were assessed
by the dermatologist using a 7-point clinical score scale ranging from
-3 (greatly decreased or worsened) to 3 (greatly increased or
improved). e overall hair volume changes during the clinical trial
were assessed by the dermatologist on digital images.
Subjects also answered a 10 question questionnaire on eect of
treatment on aspects related to Quality of life (QoL) regarding hair loss
[14]. e responses were scored according to a 7 point scale ranging
from 1 (not aected at all) to 7 (extremely aected). A higher
numerical score indicated a greater concern and a lower numerical
score indicated a lesser concern for the items of the QoL questionnaire.
In addition, subjects were also asked to score product ecacy
according to a 10 points scale ranging from 1 (very poor) to 10 (very
good).
Sample size
Sample size was calculated with a two-sided 5% signicance level
and a power of 80% taking into account a 20% variation of the primary
endpoints due to both inter-individual human variability and error in
the measurement techniques. A sample size of 20 subjects per group
was necessary given an anticipated dropout rate of 20%.
Randomization
A restricted randomization list was generated using PASS 11
(version 11.0.8 for Windows; PASS, LLC. Kaysville, UT, USA) statistical
soware running on Windows Server 2008 R2 Standard SP1 64 bit
Edition (Microso, USA) by a biostatistician and stored in a safe place.
Randomization sequence was stratied using the biased coins Efron’s
algorithm with a 2:1 allocation ratio. e allocation sequence was
concealed from the in site study director in sequentially numbered,
opaque, and sealed envelopes, reporting the unblinded treatment
allocation (based on subject entry number in the study). e A4 sheet
reporting the unblinded treatment was folded to render the envelope
impermeable to intense light. Aer acceptance of the subject in the
study the appropriate numbered envelope was opened. An
independent technician dispensed either active or placebo products
according to the card inside the envelope. e study adhered to
established procedures to maintain separation between the investigator
and its collaborators and the sta that delivered the intervention.
Investigator and its collaborators who obtained outcome
measurements were not informed on the product group assignment.
Sta who delivered the intervention did not take outcome
measurements. Subjects, investigator and collaborators were kept
masked to products assignment.
Statistical Methods
Statistical analysis was performed using NCSS 8 (version 8.0.4 for
Windows; NCCS, LLC) running on Windows Server 2008 R2 64
Edition. Data normality was checked using Shapiro-Wilk W normality
test and data shape. A p value <0.05 was considered statistically
signicant. Intragroup comparisons for normally distributed data
(phototrichogram and pull test) were analyzed by two-way paired t
test. Intergroup comparisons for normally distributed data
(phototrichogram) were analyzed by two-way unpaired t test, while for
not normally distributed data a Mann-Whitney U test was performed.
Ecacy analyses were performed on the Per Protocol (PP) population,
i.e., on all subjects who completed the study without any major
protocol violations. Intergroup statistical analysis was performed on
baseline parameters. ere were no statistically signicant dierences
were between groups. Safety analyses were performed on the Safety
population, i.e. on all subjects who were assigned a subject number and
who received at least one dose of study treatment. For
phototrichogram results the percent variation was calculated as the
mean of each single variation for each treatment group.
Results
e study was conducted between March and September 2014. A
total of 70 subjects, 35 men and 35 women, were randomized in the
study, and 23 men and 23 women received the active treatment while
12 men and 12 women received the placebo (Figure 1). No major
deviation was observed in the treatment regimen. All subjects were
included in the safety analysis data set. In general, the treatment was
well tolerated. ere was only one premature study termination in 1
woman who received the active treatment, due to bloating symptoms.
Demographic and baseline characteristics (Table 2) were similar across
treatment arms, indicating an unbiased randomization and the
absence of covariates. No signicant dierences were observed
between the two groups (active and placebo) regarding age, scalp
conditions, hair length, and hair loss related parameters. Due to early
study termination, one female subject receiving the active treatment
was not included in the ecacy population. erefore this population
comprised 22 subjects in the active group and 12 in the placebo group.
All randomized male subjects were included in the ecacy population.
Citation: Narda M, Aladren S, Cestone E, Nobile V (2017) Efficacy and Safety of a Food Supplement Containing L-cystine, Serenoa repens
Extract and Biotin for Hair Loss in Healthy Males and Females. A Prospective, Randomized, Double-blinded, Controlled Clinical Trial. J
Cosmo Trichol 3: 127. doi:10.4172/2471-9323.1000127
Page 3 of 8
J Cosmo Trichol, an open access journal
ISSN:2471-9323
Volume 3 • Issue 3 • 127

Figure 1: Flow diagram of enrolment, intervention allocation, and data analysis.
Female subjects, N=35 Male subjects, N=35
Active
Treatment
N=23
Placebo
N=12
Active
Treatment
N=23
Placebo
N=12
Age 46.5 ± 2.6 44.2 ± 3.7 40.6 ± 2.5 46.4 ± 2.5
Scalp
condition
Sensitive skin 21.7% 16.7% 21.7% 33.3%
Normal skin 4.3% 16.7% 8.7% 8.3%
Oily skin 39.1% 25.0% 34.8% 33.3%
Burning, itching
sensation
4.3 8.3% 0.0% 0.0%
Sensitive skin,
stinging
sensation
4.3 0.0% 0.0% 0.0%
Sensitive skin,
Burning
sensation,
Itching
sensation
4.3 0.0% 0.0% 0.0%
Oily skin,
Desquamation
0.0% 8.3% 0.0% 0.0%
Sensitive skin,
itching
sensation
17.4% 0.0% 13.0% 0.0%
Desquamation 8.3% 8.7% 8.3%
Oily skin,
itching
sensation
0.0% 8.3% 0.0% 0.0%
Citation: Narda M, Aladren S, Cestone E, Nobile V (2017) Efficacy and Safety of a Food Supplement Containing L-cystine, Serenoa repens
Extract and Biotin for Hair Loss in Healthy Males and Females. A Prospective, Randomized, Double-blinded, Controlled Clinical Trial. J
Cosmo Trichol 3: 127. doi:10.4172/2471-9323.1000127
Page 4 of 8
J Cosmo Trichol, an open access journal
ISSN:2471-9323
Volume 3 • Issue 3 • 127

Dry dandruff,
itching
sensation
0.0% 8.3% 13.0% 16.7%
Hair Length
Short 4.3% 8.3% 95.7% 100%
Medium 65.2% 41.7% 4.3% 0.0%
Long 30.4% 50.0% 0.0% 0.0%
Hair Loss
Characteristic
s
Pull test 12.9 ± 0.4 12.8 ± 0.5 na na
AGA scoring n
(%)
II na na 7 (30.4%) 3 (25.0%)
III na na 8 (34.8%) 4 (33.3%)
III vertex na na 8 (34.8%) 5 (41.7%)
Anagen hair
(%)
na na 64.5% 63.9%
Telogen hair
(%)
na na 35.5% 36.1%
Data are means ± SE or percentage of subjects. na: not applicable.
Table 2: Demographic and baseline characteristics of study population.
Pull testing
e number of hairs removed in the pull test decreased steadily for
both treated and placebo group over the 6-month period.
Figure 2: Changes over time in Pull Test (female subjects). Data are
means ± SE of number of hair. *p<0.05 and **p<0.01 (active
vs.
placebo).
However, at 1 (M1), 3 (M3) and 6 (M6) months the decrease was
signicantly greater for the treated group compared to the placebo
group (p<0.05; Figure 2). At M3 and M6, the mean number of pulled
hairs was below the threshold for denition of aTE in the active
treatment group while this is the case only at 6 months in the placebo
group (Figure 2).
Phototrichogram
Endpoint Time Active Placebo
Anagen hair count M0 102.9 ± 2.2 102.1 ± 3.6
M3 102.9 ± 2.1 98.8 ± 4.9
M6 109.5 ± 2.1 101.1 ± 3.5
Telogen hair count M0 57.6 ± 3.4 57.5 ± 2.5
M3 56.6 ± 3.5 59.4 ± 2.2
M6 52.4 ± 3.8 58.8 ± 2.2
Anagen/telogen ratioaM0 1.93 ± 0.12 1.81 ± 0.11
M3 1.97 ± 0.13 1.71 ± 0.14
M6 2.36 ± 0.18** 1.75 ± 0.10
Table 3: Phototrichogram results (male subjects). Data are mean ± SE.
aAnagen/Telogen ratio=(Anagen hair count)/(Telogen hair count).
**p<0.01.
In men, there was a statistically signicantly increase (23.4%
increase) in the anagen/telogen ratio in the active treatment group at
M6 as compared with baseline (Table 3). ere was a statistically
signicant dierence (p<0.05) between the active treatment group and
the placebo with a +3.7% increase in the total percent of anagen hair in
the active treatment group from baseline to M6,
vs.
-0.8% decrease in
the placebo group, and a -3.7% decrease in the total percent telogen
hair in the active treatment group
vs.
a +0.8% increase in the placebo
group (Table 3).
Hair volume and hair aspect
Hair volume and hair aspect changes over time are reported in
Figure 3. For both women and men, a majority of subjects described an
increase in hair volume (slight or moderate) in the active treatment
group as compared with the placebo group from M3 (p<0.01) to M6
(p<0.01). e dierence
vs.
placebo was statistically signicant from
M1. Hair aspect was signicantly improved (p<0.05) at M6 with more
improved subjects in the active group as compared with the placebo
group.
Figure 3: Changes over time in overall hair volume and hair aspect
(female and male subjects). Data are % of subjects showing an
improvement. *p<0.05 and **p<0.01 (active
vs.
placebo).
Citation: Narda M, Aladren S, Cestone E, Nobile V (2017) Efficacy and Safety of a Food Supplement Containing L-cystine, Serenoa repens
Extract and Biotin for Hair Loss in Healthy Males and Females. A Prospective, Randomized, Double-blinded, Controlled Clinical Trial. J
Cosmo Trichol 3: 127. doi:10.4172/2471-9323.1000127
Page 5 of 8
J Cosmo Trichol, an open access journal
ISSN:2471-9323
Volume 3 • Issue 3 • 127

Quality of life
e cumulative results from QOL questionnaire showed an
improvement in the Lambdapil® treated group compared to baseline
values aer 3 and 6 months of treatment.
Month Active Placebo Intergroup stat.
analysis
0 19.7 ± 1.4 20.6 ± 2.6 n.s.
3 18.3 ± 1.2 28.5 ± 3.3 *
6 18.2 ± 1.2 24.0 ± 3.1 n.s.
Table 4: Quality of life questionnaire (male and female subjects). Data
are reported as the sum of the score given to each question ± SE.
Statistical analysis is reported as follows:*p<0.05 I.
is was opposed to the placebo group where a worsening in QOL
cumulative scores was at the same time points (Lambdapil®
vs.
placebo,
p<0.05 at 3 months; Table 4).
Self-Assessment of Ecacy All subjects responded to questionnaire
regarding their perception of ecacy of treatment. Results from the
questionnaire are presented in Table 5. Overall, Lambdapil® treated
subjects noticed a greater improvement in indicators of hair growth
compared to the placebo group.
Item Active (n=45) Placebo (n=25)
Have you noticed a decrease of
hairs loss?
66.7% (n=30) 54.2% (n=13)
Have you noticed the growth of new
hairs?
57.8% (n=23) 37.5% (n=9)
Have you noticed an increase of
hairs thickness?
57.8% (n=26) 37.5% (n=9)
Do your hairs grow faster? 62.2% (n=28) 58.3% (n=14)
Has the treatment reinforced your
hair?
68.9% (n=31) 41.7% (n=10)
Has the treatment increased of
brightness of hair?
64.4% (n=29) 45.8% (n=15)
Has the treatment increased hair
volume?
64.4% (n=29) 45.8% (n=11)
Has the treatment reinforced your
nails?
51.1% (n=23) 58.3% (n=14)
Table 5: Self-assessment questionnaire (male and female subjects).
Data are reported as % of subjects scoring product ecacy ≥ 6
(sucient).
Global photographic assessment
Figure 4 shows the macroscopic eect of the product on hair
volume. An increase in hair volume was seen in the frontal and parietal
area (vertex) of the scalp.
Digital photography-T0 baseline, T3 3 months, T6 6 months (a-b).
Figure 4: Digital photography. T0-baseline, T3-3 months, T6-6
months (a-b).
Discussion
ere is little doubt that nutrition inuences hair loss pathologies
[15,16] and that food supplements work on several factors of this
complex etiology can help in the management of hair loss [17,18]. is
randomized, double-blind, placebo-controlled trial studied the ecacy
of Lambdapil®, a food supplement containing
Serenoa Repens
and
Equisetum arvense
extract (rich in silicon), vitamins (B3, B5, B6, D-
Biotin), amino acids (L-cystine, taurine), and zinc, in women with aTE
and in men with AGA. aTE involves intense hair loss that usually lasts
a few months but is reversible. Women seem to be more prone to this
kind of hair loss that usually happens 2-5 months aer a trigger event.
Women suering from aTE nd the condition stressful as they notice a
large number of hair being lost daily. Although aTE eventually reverses
naturally, in the present study Lambdapil® supplementation helped the
reversal of this condition in a shorter time span compared to placebo
controls as evidenced by the results from the pull test.
In men with AGA, an increase of 23.4% in the anagen/telogen ratio
from baseline to the end of the 6-month treatment period was
observed in patients taking Lambdapil® whereas no such increase was
observed in the placebo group. e anagen hair count increase aer a
6-month period treatment corresponding to 6.7 new hairs in the area
of phototrichogram which when roughly extrapolated to whole scalp
area translates to 2,159 new hairs aer 6 month supplementation (scalp
area 580 cm2; RIVM data). In contrast, there was no increase in hair
count in placebo-treated subjects, even if a negative variation (not
statistically signicant) of anagen hair count was recorded.
Finally, body image is a psychological concept that refers to a
person’s perception related to his or her physical appearance. For many
people, hair is a physical attribute that forms a large part of the feeling
of attractiveness or unattractiveness. In this respect the ndings related
to improvement in both hair aspect and hair volume in Lambdapil®
Citation: Narda M, Aladren S, Cestone E, Nobile V (2017) Efficacy and Safety of a Food Supplement Containing L-cystine, Serenoa repens
Extract and Biotin for Hair Loss in Healthy Males and Females. A Prospective, Randomized, Double-blinded, Controlled Clinical Trial. J
Cosmo Trichol 3: 127. doi:10.4172/2471-9323.1000127
Page 6 of 8
J Cosmo Trichol, an open access journal
ISSN:2471-9323
Volume 3 • Issue 3 • 127

group are considered very relevant as are the improved score for the
subject’s self-perception of improvement in hair quality and strength
from the results of the survey that the subjects responded to.
Although many of the components of the food supplement used in
this study are supported by scientic literature for their use in
alleviating signs of alopecia, in our knowledge this is the rst report of
a controlled, randomized clinical study that reports benets for women
with aTE and men with AGA with supplementation with a product
that contains these ingredients. In Morgantil et al. a combination of
Serenoa repens
extract and gelatin-cystine
via
oral route, increase
signicantly (around 25%) hair number/cm² and total hair mass/cm²
vs.
placebo at 30 weeks in patients with androgenic alopecia [19].
Lambdapil® oral supplements had a good safety prole with only 1
adverse event reported. Although the drug treatments for alopecia
available today are ecacious against both male and female alopecia,
they are associated with sexual and non-sexual side eects reported in
younger men with nasteride [20]. Oral supplements such as
Lambdapil® are a practical option for persons wanting to address
alopecia but without the side eects associated with drugs.
e strength of this study was the high-level methodology
employed: placebo-controlled, double-blind, 6-month duration study;
use of digital photographs for assessments of changes in AGA.
Although the research has reached its aim, there were some
unavoidable limitations. Firstly, the use of the pull test to assess the
changes for aTE may be considered as a limitation, as it was described
to be a test dicult to standardize due to the intrinsic variability of the
technique [6]. We justify its use as the only parameter available to
assess aTE in a clinical setting. Secondly, the small sample size may be
considered a limitation. Even if a priori sample size was calculated, to
generalize the results for larger groups, the study should have involved
more participants in order to take into account possible faults of the
stratied random sampling design and the power of statistical tests.
Finally, the self-assessment questionnaire is subjective. However even if
the output of a self-assessment questionnaire is not robust itself, when
associated to clinical/instrumental measurements it is useful to
understand if products eects are perceived by the subjects
participating in the study.
In conclusion, the oral supplementation with Lambdapil® capsules,
for 6 months, was ecacious in improving the signs and symptoms
related to aTE in women and AGA in men, and was suitably well
tolerated with negligible adverse events. It appears to be a safe and
ecacious way to address hair loss that ts in comfortably with the
daily routines of persons suering from this condition.
Contributors
SA designed the study protocol and was responsible for manuscript
reviewing; EC performed the experiments. VN wrote the study
protocol/manuscript and was responsible for data analysis and
interpretation. MN was responsible for writing and reviewing the
manuscript.
Acknowledgements
e authors thank all of the Complife Italia sta who contributed to
and recruited subjects for this study for their professionalism and
support during the study development.
Conict of Interest and Funding
is study was funded by Isdin SA. Isdin SA was involved in the
design of the study protocol and provided the test products samples.
Employees of the Sponsor were not involved in data analysis. e
manuscript was prepared by Dr. Vincenzo Nobile. Isdin SA was
permitted to review the manuscript and suggest changes, but the nal
decision on content was exclusively retained by Dr. Vincenzo Nobile.
Dr. Vincenzo Nobile is the guarantor for this manuscript, and takes
responsibility for the integrity of the work as a whole. SA and MN
work for Isdin SA.
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Extract and Biotin for Hair Loss in Healthy Males and Females. A Prospective, Randomized, Double-blinded, Controlled Clinical Trial. J
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Citation: Narda M, Aladren S, Cestone E, Nobile V (2017) Efficacy and Safety of a Food Supplement Containing L-cystine, Serenoa repens
Extract and Biotin for Hair Loss in Healthy Males and Females. A Prospective, Randomized, Double-blinded, Controlled Clinical Trial. J
Cosmo Trichol 3: 127. doi:10.4172/2471-9323.1000127
Page 8 of 8
J Cosmo Trichol, an open access journal
ISSN:2471-9323
Volume 3 • Issue 3 • 127