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Efficacy and Safety of L-Cystine Associated or not to a Natural Keratin (Kera-Diet®) Hydrolysate on Hair and Nails: Randomised, PlaceboControlled, Clinical Trial on Healthy Females

Authors:
  • Complife Italia S.r.l.

Abstract and Figures

Background: The acute Telogen Effluvium (aTE) and the Brittle Nail Syndrome (BNS) are two medical conditions affecting both males and females. A dietary approach based on aminoacids and/or on protein hydrolysate could be a safe and effective approach in reducing hair loss during acute telogen effluvium and in improving brittle nails conditions. Objective: In this study, we investigated the efficacy of L-cystine (CYS) associated or not to a commercially available hydrolysate (KDC) of natural keratin obtained from a non-human source (feathers) in improving both aTE and BNS symptoms. Design: A randomised, parallel group study was carried out for 3 months on 60 female subjects with aTE and BNS. Each subject attended clinic visits at the time of randomization (baseline) and after 45 and 90 days of products use. Anagen/Telogen hair, hair density, pull test, global photography, hair and nail brightness, and nail plate growth rate were measured. At the end of the study, a self-assessment test was carried out. Result: A statistical significant increase of hair density, hair and nails brightness, and nail plate growth rate were observed both in the CYS and KDC treatment group. Conclusion: This study demonstrates that L-Cystine alone or a mix Kera-Diet®+L-Cystine, associated with traced elements and specific vitamins at the right dosage can enhance hair and nails conditions, even though human nutrition is more and more balanced.
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ISSN: 2471-9323
Journal of Cosmetology & Trichology
Nobile et al., J Cosmo Trichol 2019, 5:1
DOI: 10.4172/2471-9323.1000142
Open Access
Research Article
Volume 5 • Issue 1 • 1000142
J Cosmo Trichol, an open access journal
ISSN: 2471-9323
Keywords: L-Cystine; Hydrolysed keratin; Acute telogen euvium;
Brittle nail syndrome; Clinical study
Introduction
Acute Telogen Euvium (aTE) is triggered when a physiologic
stress causes a large number of hair in the growing phase of the hair
cycle (anagen) to abruptly enter the resting phase (telogen). e
duration interruption of the anagen hair growth varies from 1 to 6
months (3 months average time), although this interruption of growth
is not noticed by the patient. When hair re-enter the anagen phase, hair
in the telogen phase are extruded from the follicle and hair shedding is
noticed by the subject [1-3]. Common triggering events causing aTE
are acute febrile illness, severe infection, major surgery, severe trauma,
postpartum hormonal changes, hypothyroidism, discontinuing
oestrogen-containing medication, crash dieting, low protein intake,
malnutrition, heavy metal ingestion, iron/zinc deciency, and seasonal
variation (July to October) [1]. However, clear evidence in supporting
such events is lacking [4]. e exact prevalence of aTE is not known, but
it is considered to be quite common. aTE can occur in either sex, though
women have a greater tendency to experience this condition because of
postpartum hormonal changes. Also, women are more disturbed by
hair shedding than men and are therefore more likely to seek medical
attention [2]. Despite the being benign and mild condition of aTE, the
associated psycho-emotional stress may aect the subjects quality of
life, and may sometimes lead to secondary morbidity [5-7]. e main
factors contributing to psychoemotional stress are inability to style
hair, dissatisfaction with appearance, concern about the continuing
hair loss and concern about others noticing hair loss [8]. e “brittle
nail syndrome” (BNS) is a common condition involving the tendency
of nail to peel, chip, split, crack, fray, or layer, to be fragile, thin,
ragged, rough, dull, brittle, and/to break easily. is common medical
condition aects approximately 30% of women (twice the percentage
of men), with a higher prevalence among the elderly. Several factors,
including anemia, biotin deciency, or cysteine deciency have been
postulated as causes of nail brittleness. Another proposed causative
or exacerbating factor is nail plate dehydration either from repetitive
cycles of hydration and dehydration related to hand washing or from
using dehydrating chemicals [9]. Most of the persons aected of BNS
considered it an important cosmetic problem, which interfered in daily
life activities [10-12]. Because of the slow growth rate of the nail plate
(3 mm/month for ngernails and 1.5 mm/month for toenails) and the
diculty of getting the drug active to penetrate the nail tissues, it is
usually necessary to wait several months before seeing the ecacy of
treatments.is delay oen leads to discontinuation of therapy by the
patients [13]. BNS is also associated with the presence of depressive
*Corresponding author: Farcoderm srl, Complife Group, Via Mons Angelini,
21, 27028 San Martino Siccomario, Pavia, Italy, Tel: +39-0382-25504; E-mail:
vincenzo.nobile@complifegroup.com
Joel Duperray, BCF Life Sciences, Boisel, 56140 Pleucadeuc, France, Tel +33 2 97
26 91 21; E-mail: jduperray@bcf-lifesciences.com
Received March 07, 2019; Accepted March 28, 2019; Published April 11, 2019
Citation: Nobile V, Duperray J, Cestone E, Sergheraert R, Tursi F (2019) Efcacy
and Safety of L-Cystine Associated or not to a Natural Keratin (Kera-Diet®)
Hydrolysate on Hair and Nails: Randomised, Placebo-Controlled, Clinical Trial on
Healthy Females. J Cosmo Trichol 5: 142. doi:10.4172/2471-9323.1000142
Copyright: © 2019 Nobile V, 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: The acute Telogen Efuvium (aTE) and the Brittle Nail Syndrome (BNS) are two medical conditions
affecting both males and females. A dietary approach based on aminoacids and/or on protein hydrolysate could be
a safe and effective approach in reducing hair loss during acute telogen efuvium and in improving brittle nails
conditions.
Objective: In this study, we investigated the efcacy of L-cystine (CYS) associated or not to a commercially
available hydrolysate (KDC) of natural keratin obtained from a non-human source (feathers) in improving both aTE
and BNS symptoms.
Design: A randomised, parallel group study was carried out for 3 months on 60 female subjects with aTE and
BNS. Each subject attended clinic visits at the time of randomization (baseline) and after 45 and 90 days of products
use. Anagen/Telogen hair, hair density, pull test, global photography, hair and nail brightness, and nail plate growth
rate were measured. At the end of the study, a self-assessment test was carried out.
Result: A statistical signicant increase of hair density, hair and nails brightness, and nail plate growth rate were
observed both in the CYS and KDC treatment group.
Conclusion: This study demonstrates that L-Cystine alone or a mix Kera-Diet®+L-Cystine, associated with
traced elements and specic vitamins at the right dosage can enhance hair and nails conditions, even though human
nutrition is more and more balanced.
Efficacy and Safety of L-Cystine Associated or not to a Natural Keratin
(Kera-Diet®) Hydrolysate on Hair and Nails: Randomised, Placebo-
Controlled, Clinical Trial on Healthy Females
Vincenzo Nobile1*, Joel Duperray2*, Enza Cestone1, Renaud Sergheraert2 and Francesco Tursi1
1Farcoderm srl, Complife Group, Via Mons Angelini, 21, 27028 San Martino Siccomario, Pavia, Italy
2BCF Life Sciences, Boisel, 56140 Pleucadeuc, France
Citation: Nobile V, Duperray J, Cestone E, Sergheraert R, Tursi F (2019) Efcacy and Safety of L-Cystine Associated or not to a Natural Keratin
(Kera-Diet®) Hydrolysate on Hair and Nails: Randomised, Placebo-Controlled, Clinical Trial on Healthy Females. J Cosmo Trichol 5: 142.
doi:10.4172/2471-9323.1000142
Volume 5 • Issue 1 • 1000142
J Cosmo Trichol, an open access journal
ISSN: 2471-9323
Page 2 of 9
agents, interferon alpha) aecting the hair growth taken for more than
4 consecutive weeks during the last 24 weeks before inclusion visit, and
systemic or local androgenetic alopecia treatment or product, taken
or applied (Minoxidil, Aminexil, Finasteride, Dutasteride, cosmetic
solution or capsules with vitamin B, zinc, caeine) for more than 4
consecutive weeks during the last 24 weeks before the inclusion visit,
and subjects having excessive and/or uctuating hair shedding for
more than 6 months. Changes in hairstyle or dyeing of the hair were
not allowed during all the study period. During all the study period
subjects were asked to not cut their nails 7 days before and aer each
checkpoint. Two (n=2) more subjects per each group were enrolled in
order to take into account an anticipate drop-out rate by 10%.
Intervention
e test product was on L-cystine 250 mg and a commercially
available hydrolysate of natural keratin 250 mg (Kera-Diet®), obtained
from a non-human source and having an amino acid prole similar
to the hair. Kera-Diet® amino acids prole consists of 17 amino acids
(7.6% Asp, 12.4% Ser, 11.8% Pro, 11.3% Glu, 8.6% Gly, 8.2% Val,
7.7% Leu, 6.4% Arg, 5.5% Cys, 5.1% r, 5% Ala, 4.6% Ile, 2.5% Phe,
2% Lys, 0.7% His, 0.3% Tyr, 0.2% Met.) of which 86.5% are in free
form (Figure 1). e ingredients were supplied by BCF Life Sciences
(Boisel, 56140 Pleucadeuc, France). Subjects were randomly assigned
to receive L-cystine (CYS group), Kera-Diet®+L-Cystine (KDC group),
or the placebo product (PLA group). e ingredients were formulated
in gelatin capsule (Table 1). All the treatment groups were asked to
consume four capsules per day (1000 mg/day), two at breakfast and
two at dinner, for a total period of 90 days.
Primary and secondary outcomes
e primary endpoints with respect to product ecacy were the
measurement nagen/telogen hair and the nail growth speed. Hair
resistance to traction (pull testing), hair/nail brightness, and overall
hair/nail condition, were secondary ecacy endpoints. e study low
and the schedule of assessments chart is reported in Figure 2.
Phototrichogram
Digital images for TrichoScan® analysis (soware version 2.3) were
taken in the mid vertex area. he area (1.8 cm2) was clipped evenly using
a hair trimmer (Moser, TrichoScan Edition) and short clipped hair
were removed by pressing an adhesive strip onto the shaved area. On
day 3 (72 ± 2 hours aer hair clipping), the clipped hair within the
disorders, indicating a possible impact on the quality of life of those
who experience them, similarly to what occurs with hair loss perception
[14].
In this study, we tested the ecacy on both aTE and BNS of Lcystine
(Traced L-Cystine®, BCF® Life Sciences, Boisel, 56140 Pleucadeuc,
France) associated or not to a commercially available hydrolysate of
natural keratin (Kera-Diet®, BCF® Life Sciences), obtained from a non-
human source (feathers).
Methods
Study design
is monocentric, randomised, parallel group, double-blind,
placebo-controlled study was carried out in accordance with the
Declaration of Helsinki. e study protocol and the informed consent
form were approved by the “Independent Ethical Committee for Non-
Pharmacological Clinical trials” during its meeting on December 12th
2016. All subjects provided writte informed consent before initiation
of any study-related procedures. e study took place at Complife
Italia dermatological facilities in San Martino Siccomario (PV), Italy.
Complife Italia 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 all female adults, having ongoing acute
telogen euvium and brittle nails (not pathological condition). e
subjects were of general good health, aged between 30 and 60 years
old, had no alimentary/eating disorders (i.e. bulimia, psychogenic
eating disorders, etc.), and known history of metabolic syndrome.
Exclusion criteria were pregnancy or intention to become pregnant,
lactation, food intolerance/allergy, pharmacological treatments known
to interfere with the test product or having an eect on metabolism,
participation in another similar study, unwillingness or inability
to comply with the requirements of the study protocol, history for
radiotherapy/chemotherapy treatments, and scalp surgery (e.g. hair
transplantation). e study further excluded subjects using food
supplements containing active ingredients having an inuence on hair
loss/growth and on nail plate, oestrogen-progesterone contraception
or hormonal treatment therapies within 3 months before starting the
study, systemic treatments (e.g. retinoids, anti-mitotic, cytotoxic drugs
other than antineoplastic, anti-androgens, androgens, anti-epileptic
Asparc acid
Threonine
Serine
Glutamic acid
Glycine
Alanine
Valine
Cysne
Methionine
Isoleucine
Leucine
Tyrosine
Phenylalanine
Lysine
Hisdine
Arginine
Proline
7,6
5,1
12.4
11,3
8,6
5,0
8,2
5,5
4.6
0.20
7,7
0,3
2,5 2,0
0,7
6,4
11,8
Part of Free amino acids
Kera-Diet amino acids content (in %)
Figure 1: Kera-Diet® aminoacidic composition.
Citation: Nobile V, Duperray J, Cestone E, Sergheraert R, Tursi F (2019) Efcacy and Safety of L-Cystine Associated or not to a Natural Keratin
(Kera-Diet®) Hydrolysate on Hair and Nails: Randomised, Placebo-Controlled, Clinical Trial on Healthy Females. J Cosmo Trichol 5: 142.
doi:10.4172/2471-9323.1000142
Volume 5 • Issue 1 • 1000142
J Cosmo Trichol, an open access journal
ISSN: 2471-9323
Page 3 of 9
target area were died (Goldwell topchic, black 2N, Darmstadt, Germany
with Rondo 6% CrèmeOxyd, Coieur, Cologne, Germany). Aer 15
minutes the colored area was thoroughly cleaned with an alcoholic
solution (Kodan® Spray, Schülke and Mayr, Vienna, Austria) and
digital images were taken using a DermoGenius camera (DermoScan
GmbH, D-93055 Regensburg, Germany). To improve the accuracy of
taking phototricogram from the same area, a homemade repositioning
device was used instead of tattoo land marking.
Pull test
Approximately 20-60 hairs were grasped between the thumb, index
and middle ngers from the base of the hairs near the scalp and rmly,
but not forcefully, tugged away from the scalp in three dierent areas
(frontal, temporal, and occipital region). 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
Subjects screening
Subj. meets
incl. crit.?
Screening visit
Subj. meets
incl. crit.?
YES
NO
NO
YES
1st week of September - 1st week of October
V0-14
V0-3
V0
V1-7
V1
V1+3
V1+7
V2-7
V2
V2+3
V2+7
0
45 days
90 days
NC
PHc
PT,BR,SM,
GP,CL,NG,
PHm
NC
PT,BR,SM,
GP,CL,NG,
PHc
PHm
NG
NC
PT,BR,SM,
GP,CL,NG,
PHc
PHm
NG
AE
occurence?
Dermatologist check
Is the
AE related
to product
use?
Study stop - Subject
withdrawal
stop
&
restart
product
use?
AE occurs
aer the stop
period?
YES
NO
Need for further invesgaon
YES
NO
YES
Is AE
disappeared and
subject can connue
using the
product?
NO
Subject connue the
study
NO
YES
Figure 2: Study ow and schedule of assessment chart. Legend: NC nail cut, PHc Photricogram hair cutting, PT pull testing, BR Brightness measurement, GP
Global photography, CL Global photography scoring, NG Nail growth rate, PHm Photricogram hair measurement, SA Self-assessment questionnaire.
Ingredients CYS 250 mg L-Cystine KDC250 mg Kera-Diet®+250 mg L-Cystine PLA Placebo
Maltodextrin 250 --- 524.3
L-Cystine 250 250 ---
Kera-Diet®--- 250 ---
Magnesium stearate 14 14 14
Zinc sulphate heptahydrate (22% Zn) 11.36 11.36 ---
Silice 5 5 5
Vitamin B3 (nicotinamide) 4.5 4.5 ---
Vitamin B5 (D-Calcium pantothenate) 3.72 3.72 ---
Dry extract of aerial part of Equisetum Arvense 2.5 2.5 ---
Copper sulphate pentahydrate 1.48 1.48 ---
Vitamin B6 (pyridoxine hydrochloride) 0.6326 0.6326 ---
Vitamin B8 (biotin) 0.075 0.075 ---
Table 1: Capsules composition: Quantities are reported in mg/capsule.
Citation: Nobile V, Duperray J, Cestone E, Sergheraert R, Tursi F (2019) Efcacy and Safety of L-Cystine Associated or not to a Natural Keratin
(Kera-Diet®) Hydrolysate on Hair and Nails: Randomised, Placebo-Controlled, Clinical Trial on Healthy Females. J Cosmo Trichol 5: 142.
doi:10.4172/2471-9323.1000142
Volume 5 • Issue 1 • 1000142
J Cosmo Trichol, an open access journal
ISSN: 2471-9323
Page 4 of 9
obtained, the pull test was considered positive and suggestive of telogen
euvium.
Global photography scoring
Photographic pictures at the vertex and frontal level were taken
under standard lighting conditions, using a professional digital reex
camera NIKON D300/D600 digital (Nital S.p.A., 10024 Moncalieri,
To, Italy) camera equipped with a macro-objective (AF-S Micro
NIKKOR 60 mm f/2.8G ED), an independent ash system (Kit R1C1)
and with cross- and parallel-polarised lters. Pictures were scored
using a standardised seven-point rating scale (+3 greatly increased; +2
moderately increased; +1 slightly increased; 0 no change; -1 slightly
decreased; -2 moderately decreased; -3 greatly decreased) [15]. is
technique had been demonstrated to have excellent reproducibility
[16].
Brightness
Hair and nails brightness was measured using a spectrophotometer/
colorimeter CM-700D (Konica-Minolta, 20092 Cinisello Balsamo, MI,
Italy). e measured parameter was the 8 gloss (specularly reected
light).
Nail growth
Nail picture were taken at each checkpoint before and aer cutting
(Figure 2). Nail plate growth was measured, using a morphometric
image analysis technique, as the dierence between the total nail length
aer cutting and the total nail length aer 14 days from cutting.
Nail conditions
Pictures were scored using a four-point rating scale (1 no eect; 2
mild eect; 3 moderate eect; 4 strong eect).
Self-assessment questionnaire
At the end of the study, subjects were asked to reply to the questions
of a self-assessment questionnaire.
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. Sample size was calculated using
PASS 11 statistical soware (version 11.0.8 for Windows) running
on Windows Server 2008 R2 Standard SP1 64 bit edition (Microso,
USA). A sample size of 20 subjects per group was necessary given an
anticipated dropout rate of 20%.
Randomisation
A restricted randomisation list was created using PASS 11 (version
11.0.8; 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.
Randomisation sequence was stratied using biased coin Efron’s
algorithm with a 1:1:1 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 make 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. e active and the placebo products
were in capsule form and identical in appearance. ey were prepacked
in blisters and consecutively numbered for each subject according to the
randomisation schedule. Each subject was assigned an order number
and received the capsules in the corresponding prepacked blister.
Statistical methods
Statistical analysis was performed using NCSS 10 (version 10.0.12
for Windows; NCCS, LLC. Kaysville, UT, USA) running on Windows
Server 2008 R2 Standard SP1 64 bit edition (Microso, USA). Data
normality was checked using Shapiro-Wilk W normality test and
data shape. Intragroup (vs. baseline) statistical analysis was carried
out using repeated measures analysis of variance (RM-ANOVA)
followed by Tukey-Kramer post-test. Intergroup (between treatments)
statistical analysis was carried out using RM-ANOVA followed by tests
for two factor interactions. A p-value<0.05 was considered statistically
signicant. Statistical analysis output was reported as follows: *p<0.05,
**p<0.01 and ***p<0.001.
Results
Subjects
e study was conducted between February and July 2017. A total
of 60 female subjects were successfully randomized (Figure 3). e
population was caucasian. Demographic and baseline characteristics
(Table 2) were similar across treatment arms, indicating an unbiased
randomization and the absence of covariates. Subjects attended clinic
visits at the time of randomization (baseline) and aer 45 and 90 days
of product use. Data analysis was intention-to-treat and involved all
subjects who were randomly assigned.
Subjects’ compliance to treatment was assessed by means of
product accountability as follows: at each visit, the expected amount
of consumed capsule was compared with the amount dispensed minus
the amount the subject returned. No major deviations were observed
in the treatment regimen. All subjects were included in the safety
analysis data set. All the tested products were well tolerated. No adverse
reactions occurred during the study period.
Phototrichogram
A statistical signicant increase of hair density was observed both
CYS KDC PLA
Sex
Female 100% 100% 100%
Phototricogram
%Telogen 21.2 ± 1.0 21.5 ± 0.8 21.0 ± 0.8
%Anagen 78.8 ± 1.0 78.5 ± 0.8 79.0 ± 0.8
Hair density (hair no/cm2) 193.1 ± 6.1 195.5 ± 4.8 193.2 ± 7.4
Pull test 12.1 ± 0.3 12.7 ± 0.4 12.3 ± 0.3
Hair radiance 3.33 ± 0.32 3.31 ± 0.38 3.33 ± 0.35
Nail growth rate (mm/14 days) 1.25 ± 0.05 1.21 ± 0.05 1.26 ± 0.06
Nail brightness 7.38 ± 0.63 7.11 ± 0.75 7.28 ± 0.51
Table 2: Demographic and baseline characteristics. Data are means ± SE.
Citation: Nobile V, Duperray J, Cestone E, Sergheraert R, Tursi F (2019) Efcacy and Safety of L-Cystine Associated or not to a Natural Keratin
(Kera-Diet®) Hydrolysate on Hair and Nails: Randomised, Placebo-Controlled, Clinical Trial on Healthy Females. J Cosmo Trichol 5: 142.
doi:10.4172/2471-9323.1000142
Volume 5 • Issue 1 • 1000142
J Cosmo Trichol, an open access journal
ISSN: 2471-9323
Page 5 of 9
Assessed for eligibility (n = 76)
Excluded (n = 16
)
- Not meeng the inclusion criteria (n = 7)
- Declined to parcipate in the study (n = 9)
Randomized (n = 60)
Lost to follow-up
(n = 0)
Disconnued
intervenon (n = 0)
Allocated to
intervenon
(n = 20)
- Received allocated
intervenon (n = 20)
- Did not received
allocated intervenon
(n = 0)
Included in the
analysis (n = 20)
Excluded from
analysis (n = 0)
Lost to follow-up
(n = 0)
Disconnued
intervenon (n = 0)
Allocated to
intervenon
(n = 20)
- Received allocated
intervenon (n = 20)
- Did not received
allocated intervenon
(n = 0)
Included in the
analysis (n = 20)
Excluded from
analysis (n = 0)
Lost to follow-up
(n = 0)
Disconnued
intervenon (n = 0)
Allocated to
intervenon
(n = 20)
- Received allocated
intervenon (n = 20)
- Did not received
allocated intervenon
(n = 0)
Included in the
analysis (n = 20)
Excluded from
analysis (n = 0)
KDC
CYS
PLA
Figure 3: CONSORT 2010 ow diagram. Legend. 1) Enrolment, 2) Allocation, 3) Follow-up, 4) Analysis.
a) Hair density (number/cm2) n Mean ± SE Min ÷ Max
KDC CYS PLA KDC CYS PLA
Day 0 20 195.5 ± 4.8a 193.1 ± 6.1a 193.2 ± 7.4a 157.2 ÷ 251.9 152.7 ÷ 252.3 138.3 ÷ 246.2
Day 45 20 198.9 ± 4.8a 198.2 ± 6.1b 194.0 ± 7.1a 160.7 ÷ 247.5 160.1 ÷ 258.5 142.2 ÷ 248.4
Day 90 20 211.3 ± 4.9b 209.4 ± 6.1c 195.0 ± 7.2a 170.3 ÷ 270.4 165.2 ÷ 268.3 145.7 ÷ 256.3
D45-D0 20 3.4 ± 1.05.0 ± 1.20.8 ± 0.8 -4.4 ÷ 11.2 -6.2 ÷ 12.9 -5.5 ÷ 5.9
D90-D0 20 15.8 ± 1.816.3 ± 2.41.8 ± 0.9 -0.3 ÷ 31.3 -3.4 ÷ 40.2 -2.8 ÷ 10.1
b) Anagen hair (%) n Mean ± SE Min ÷ Max
KDC CYS PLA KDC CYS PLA
Day 0 20 78.5 ± 0.8a 78.8 ± 1.0a 79.0 ± 0.8a 71.6 ÷ 83.8 71.1 ÷ 84.5 71.6 ÷ 83.7
Day 45 20 82.7 ± 0.7b 83.2 ± 0.7b 78.6 ± 0.7a 74.6 ÷ 89.5 77.9 ÷ 88.8 71.1 ÷ 84.5
Day 90 20 88.2 ± 0.5c 89.1 ± 0.6c 82.2 ± 0.7b 83.6 ÷ 91.9 83.6 ÷ 91.9 74.5 ÷ 87.6
D45-D0 20 4.3 ± 0.54.4 ± 0.6-0.4 ± 0.5 0.6 ÷ 8.2 -0.2 ÷ 11.2 -5.5 ÷ 3.2
D90-D0 20 9.7 ± 0.610.3 ± 0.73.2 ± 0.9 4.6 ÷ 13.8 6.0 ÷ 18.2 -1.9 ÷ 12.3
c) Telogen hair (%) n Mean ± SE Min ÷ Max
KDC CYS PLA KDC CYS PLA
Day 0 20 21.5 ± 0.8c 21.2 ± 1.0c 21.0 ± 0.8c 16.2 ÷ 28.4 15.5 ÷ 28.9 16.3 ÷ 28.4
Day 45 20 17.3 ± 0.7b 16.8 ± 0.7b 21.4 ± 0.7b 10.5 ÷ 25.4 11.2 ÷ 22.1 15.5 ÷ 28.9
Day 90 20 11.8 ± 0.5a 10.9 ± 0.6a 17.9 ± 0.7b 8.1 ÷ 16.4 8.1 ÷ 16.4 12.4 ÷ 25.5
D45-D0 20 -4.3 ± 0.5-4.4 ± 0.60.4 ± 0.5 -8.2 ÷ -0.6 -11.2 ÷ 0.2 -18.2 ÷ -6.0
D90-D0 20 -9.7 ± 0.6-10.3 ± 0.7-3.2 ± 0.9 -13.8 ÷ -4.6 -5.5 ÷ 3.2 -12.3 ÷ 1.9
d) Pulled hair (hair no.)
n
Mean ± SE Min ÷ Max
KDC CYS PLA KDC CYS PLA
Day 0 20 12.7 ± 0.4c 12.1 ± 0.3c 12.3 ± 0.3c 11 ÷ 16 11 ÷ 16 11 ÷ 16
Day 45 20 9.6 ± 0.5b 8.4 ± 0.5b 12.4 ± 0.5c 5 ÷ 14 3 ÷ 13 10 ÷ 20
Day 90 20 8.3 ± 0.3a 7.2 ± 0.4a 11.0 ± 0.5b 5 ÷ 00 3 ÷ 10 8 ÷ 16
D45-D0 20 -3.1 ± 0.4-3.8 ± 0.50.2 ± 0.4 -1 ÷ -7 -1 ÷ -8 4 ÷ -2
D90-D0 20 -4.4 ± 0.4-4.9 ± 0.4-1.3 ± 0.3 -2 ÷ -8 - ÷ -8 1 ÷ -3
Table 3: Phototricogram and pull testing results. (a) Hair density. (b) Anagen hair. (c) Telogen hair. (d) Pull test results. Signicantly different from D0: a<b<c, p<0.05.
RM-ANOVA followed by Tukey-Kramer post-test. Signicantly different (p<0.05) from Placebo. RM-ANOVA followed by tests for two-factor interactions. Data are
means ± SE.
Citation: Nobile V, Duperray J, Cestone E, Sergheraert R, Tursi F (2019) Efcacy and Safety of L-Cystine Associated or not to a Natural Keratin
(Kera-Diet®) Hydrolysate on Hair and Nails: Randomised, Placebo-Controlled, Clinical Trial on Healthy Females. J Cosmo Trichol 5: 142.
doi:10.4172/2471-9323.1000142
Volume 5 • Issue 1 • 1000142
J Cosmo Trichol, an open access journal
ISSN: 2471-9323
Page 6 of 9
in the CYS and KDC treatment groups (Table 3a). e hair density
was increased in the CYS treatment group by 5.0 ± 1.2 and by 16.3
± 2.4, aer 45 and 90 days, respectively (p<0.001). A similar ecacy
prole was seen for the KDC treatment group where hair density
was increased by 3.4 ± 1.0 and by 15.8 ± 1.8, aer 45 and 90 days,
respectively (p<0.001). e variation of hair density was not statistically
signicant in the placebo group (p>0.05). Both CYS and KDC hair
density variation were statistically signicant when compared to the
placebo group (p<0.05).
A statistical signicant increase of anagen hair was observed both in
the CYS and KDC treatment groups (Table 3b). e percentage anagen
hair was increased in the CYS treatment group by 4.4 ± 0.6 and by 10.3
± 0.7, aer 45 and 90 days, respectively (p<0.001). A similar ecacy
prole was seen for the KDC treatment group where the percentage of
anagen hair was increased by 4.3 ± 0.5% and by 9.7 ± 0.6 aer 45 and
90 days, respectively (p<0.001). e variation of percentage of anagen
hair was not statistically signicant in the placebo group (p>0.05).
Both CYS and KDC variation in the % anagen hair was statistically
signicant when compared to the placebo group (p<0.05).
Specular but opposite results were obtained for the percentage of
telogen hair variation (Table 3c).
Pull test
A statistical signicant decrease of the number of pulled hair was
observed both in the CYS and KDC treatment groups (Table 3d). e
number of pulled hair was decreased in the CYS treatment group by
31.1 ± 3.9% and by 40.3 ± 3.5%, aer 45 and 90 days, respectively
(p<0.001).
A similar ecacy prole was seen for the KDC treatment group
where the number of pulled hair was decreased by 24.3 ± 3.5% and by
34.0 ± 2.4% aer 45 and 90 days, respectively (p<0.001). e variation
of the number of pulled hair (-10.6 ± 2.6%) was statistically signicant
in the placebo group aer 90 days. Both CYS and KDC variation in
the number of puller hair was statistically signicant when compared
to the placebo group (p<0.05). Interestingly, both for CYS and KDC
the number of pulled hair aer 45 days is not suggestive of telogen
euvium diagnosis.
Global photography scoring
Figure 4 shows the macroscopic eect of the product in decreasing
hair loss. Hair volume and nail conditions were improved both in the
CYS and KDC treatment groups. e subjects showing an improvement
of hair volume in the CYS treatment group were 5% and 60%, aer 45
and 90 days. A similar ecacy prole was seen for the KDC treatment
group where the improved subjects were 40% and 75%, aer 45 and
90 days.
e improvement was statistically signicant for both the CYS and
KDC treatment groups when compared to the placebo group (5% and
10% of the subjects, aer 45 and 90 days). e subjects showing an
improvement of nail conditions in the CYS treatment group were 30%
and 65%, aer 45 and 90 days. A similar ecacy prole was seen for
the KDC treatment group where the subjects improved were 35% and
70%, aer 45 and 90 days. e improvement was statistically signicant
for both the CYS and KDC treatment groups when compared to the
placebo group (15% and 20% of the subjects, aer 45 and 90 days).
Hair and nails brightness
A statistical signicant increase of both hair and nail brightness
(Table 4) was observed both in the CYS and KDC treatment groups.
Hair brightness in the CYS treatment group was improved by 27.2%
A
B
C
Figure 4: Global photography assessment a) KDC group b) CYS group c) PLA group.
Citation: Nobile V, Duperray J, Cestone E, Sergheraert R, Tursi F (2019) Efcacy and Safety of L-Cystine Associated or not to a Natural Keratin
(Kera-Diet®) Hydrolysate on Hair and Nails: Randomised, Placebo-Controlled, Clinical Trial on Healthy Females. J Cosmo Trichol 5: 142.
doi:10.4172/2471-9323.1000142
Volume 5 • Issue 1 • 1000142
J Cosmo Trichol, an open access journal
ISSN: 2471-9323
Page 7 of 9
Hair brightness (au) Mean ± SE Min ÷ Max
n KDC CYS PLA KDC CYS PLA
Day 0 20 3.31 ± 0.38a 3.33 ± 0.32a 3.33 ± 0.35a 1.08 ÷ 6.61 1.03 ÷ 5.64 1.04 ÷ 6.71
Day 45 20 4.08 ± 0.38b 4.29 ± 0.46b 3.28 ± 0.36a 1.55 ÷ 7.17 1.17 ÷ 8.11 1.08 ÷ 6.33
Day 90 20 4.85 ± 0.43c 5.19 ± 0.54c 3.53 ± 0.39a 1.78 ÷ 9.59 1.38 ÷ 9.17 1.17 ÷ 7.63
D45-D0 20 +31.4%+27.2%-1.90% 2.4% ÷ 96.3% -5.0% ÷ 70.9% -24.6% ÷ 18.3%
D90-D0 20 +58.9%+56.9%+6.40% 3.9% ÷ 132.4% 1.3% ÷ 137.1% -22.0% ÷ 36.5%
Nail brightness (au) Mean ± SE Min ÷ Max
n KDC CYS PLA KDC CYS PLA
Day 0 20 7.11 ± 0.75a 7.38 ± 0.63a 7.28 ± 0.51a 1.26 ÷ 12.24 3.64 ÷ 13.24 4.82 ÷ 12.66
Day 45 20 9.02 ± 0.92b 9.42 ± 1.05b 7.76 ± 0.59a 1.95 ÷ 15.22 5.64 ÷ 24.61 5.00 ÷ 13.45
Day 90 20 10.74 ± 0.99c 10.50 ± 0.66b 8.45 ± 0.69b 2.78 ÷ 17.93 5.88 ÷ 17.57 5.11 ÷ 14.85
D45-D0 20 +28.5%+29.6%+6.70% 3.3% ÷ 57.3% -34.2% ÷ 123.4% -16.1% ÷ 33.9%
D90-D0 20 +58.4%+54.5%+17.20% 29.0% ÷ 120.6% -20.4% ÷ 258.0% -24.1% ÷ 66.1%
Table 4: Hair and nail brightness. Signicantly different from D0: a<b<c, p<0.05. RM-ANOVA followed by Tukey-Kramer post-test.Signicantly different (p<0.05) from
Placebo. RM-ANOVA followed by tests for two-factor interactions. Data are means ± SE.
Growth rate
(mm/14dd)
Mean ± SE
Min ÷ Max
n
KDC
CYS
PLA
KDC
CYS
PLA
Day 0
20
1.21±0.05a
1.25±0.05a
1.26±0.06a
0.68÷1.59
0.89÷1.62
0.61÷1.60
Day 45
20
1.30±0.06
b
1.32±0.05
b
1.28±0.05
a
0.75÷1.69
0.93÷1.67
0.78÷1.65
Day 90
20
1.43±0.07c
1.35±0.05c
1.28±0.06a
0.79÷2.04
0.98÷1.66
0.69÷1.68
D45-D0
20
+0.09†
+0.06†
+0.02
0.02÷0.15
0.01÷0.13
-0.04÷0.17
D90-D0
20
+0.21†
+0.10†
+0.01
0.08÷0.45
0.02÷0.19
-0.03÷0.08
1,00
1,10
1,20
1,30
1,40
1,50
1,60
0 45 90
)syad 41/mm( htgnel etalp liaN
Time (days)
KDC CYS PLA
Figure 5: Nail growth rate. Signicantly different from D0: a<b<c, p<0.05. RM-ANOVA followed by Tukey-Kramer post-test. † Signicantly different (p<0.05) from
Placebo. RM-ANOVA followed by tests for two-factor interactions. Data are means ± SE.
and 56.9%, aer 45 and 90 days. A similar ecacy prole was seen
for the KDC treatment group where hair brightness was improved
by 31.4% and 58.9%, aer 45 and 90 days. Both CYS and KDC hair
brightness variation was statistically signicant when compared to the
placebo group (p<0.05).
Nail brightness in the CYS treatment group was improved by
29.6% and 54.5%, aer 45 and 90 days. A similar ecacy prole was
seen for the KDC treatment group where hair brightness was improved
by 28.5% and 58.4%, aer 45 and 90 days. Both CYS and KDC hair
brightness variation were statistically signicant when compared to the
placebo group (p<0.05).
Nail growth rate
A statistical signicant increase of nail growth rate was observed
both in the CYS and KDC treatment groups (Figure 5). e nail growth
rate in the CYS treatment group was 0.06 ± 0.01 mm/14days and 0.10 ±
0.01 mm/14days, aer 45 and 90 days, respectively (p<0.001). A similar
ecacy prole was seen for the KDC treatment group where nail
growth rate was 0.09 ± 0.01 mm/14days and 0.21 ± 0.02 mm/14 days,
aer 45 and 90 days, respectively (p<0.001). e nail growth rate was
not statistically signicant in the placebo group (p>0.05). Both CYS
and KDC nail growth rate was statistically signicant when compared
to the placebo group (p<0.05).
Self-assessment questionnaire
e complete results of the self-assessment questionnaire are
reported in Figure 6. Both CYS and KDC were perceived more eective
than PLA. Subjects’ answers aer 90 days product use are very positive
with 70% global satisfaction for L-Cystine for hair and nails.
It should be noted that this percentage is better with the association
L-Cystine+Kera-Diet® which obtains 90% of global satisfaction. On
the other hand, placebo eect is only 35%; this underlines that all
improvement of objectives criteria are enough visible to be perceived
by women of CYS and KDC groups.
Discussion
Shining and healthy hair and nails is the attribute of healthy people
looking aer themselves and taking good care of their body, but for
Citation: Nobile V, Duperray J, Cestone E, Sergheraert R, Tursi F (2019) Efcacy and Safety of L-Cystine Associated or not to a Natural Keratin
(Kera-Diet®) Hydrolysate on Hair and Nails: Randomised, Placebo-Controlled, Clinical Trial on Healthy Females. J Cosmo Trichol 5: 142.
doi:10.4172/2471-9323.1000142
Volume 5 • Issue 1 • 1000142
J Cosmo Trichol, an open access journal
ISSN: 2471-9323
Page 8 of 9
women, such properties are also a decoration, which gives them sense
of wellbeing.
It is nowadays clear that the nutrients of diet have a direct impact
on the structure and growth of both hair and nails. While hair follicles
are among the most metabolically active in the body, and hair growth
may be impacted by calorie and protein malnutrition as well as
micronutrient deciency, the links are complex. Eects on hair growth,
including acute telogen euvium, are a well-known eect of sudden
weight loss or decreased protein intake [17]. It has also been reported
potential associations between nutritional deciency and chronic
telogen euvium, androgenetic alopecia, female pattern hair loss, and
alopecia areata [18,19].
In recent years, use of food supplements has increased both in
Europe and in the USA with many physicians recommending them
[20,21]. A survey of health professionals conducted in 2008 showed that
66% of dermatologists (n=300) recommended dietary supplements to
patients in relation to skin, hair, and nail health and 79% of clinicians
personally used supplements [17]. A search of the keywords “hair loss”
within the Vitamins and Dietary Supplements section of an important
digital market place, which sells supplements via Internet sales, yields
923 products, many of them being dierent formulations [22]. While
such products contain a variety of nutrients, the review of the medical
literature nds a notable lack of evidence supporting their use. In fact,
even if some studies are arising in the scientic literature conrming
the ecacy of food supplements, some of them used not reliable or
standardised methods, and the study design sometimes does not
consider the placebo group.
In this study, we investigated the ecacy of two ingredients to be
used in food supplements containing, L-Cystine and hydrolysate of
natural keratin, minerals, and vitamins. In order to reach this goal,
a placebo-controlled, double-blind study was carried out in women
showing the clinical signs of aTE and BNS. Our results show clearly
that, aer 45 days of supplementation, these criteria are signicantly
enhanced with these ingredients compared to placebo.
Results demonstrate also that the observed eects are always
better at 90 days in comparison to the 45 days results, underlining the
importance of treatment duration.
e self-assessment questionnaire shows that the improvement,
instrumentally measured and clinically evaluated, is visible enough to
be perceived by women; answers to self-assessment questionnaire by
enrolled subjects aer 90 days are very positive, especially for the KDL
group, which underline benets for the customers with this association.
is illustrates that it is possible to visually enhance hair and nail health
and status, even among healthy and well-nourished people.
Conclusion
In conclusion, this study provides evidence in supporting the
hypothesis that L-Cystine or a combination of a hydrolysate of natural
keratin (Kera-Diet®) and L-Cystine could represent a safe and eective
approach in reducing hair loss during acute telogen euvium and in
improving brittle nail conditions. Specically, we have shown that a 90-
days intervention period with the test products is benecial for telogen
hair decrease and for increasing nail growth rate. erefore and more
0%
10%
20%
30%
40%
50%
60%
70%
80%
90%
100%
My hair is stronger (more
resistant)
My hair is nourished
My hair is less brile
My hair is brighter (less dull
My hair is denserMy hair is healthier
My hair is more voluminous
My hair is thicker
My hair is easily disentangled
KDC CYS PLA
0%
10%
20%
30%
40%
50%
60%
70%
80%
90%
My nails are stronger (more
resistant)
My nails are harder
My nails are thicker
My nails are less brile
My nails are less splied
My nails are brighter (less dull)
My nails are less dull
My nails are more beauful
My nails are smoother
My nails are longer
My nails grow faster
My nails are healthier
KDC CYS PLA
90,0%
85,0%
75,0%
70,0%
65,0%
65,0%
35,0%
35,0%
30,0%
0%
10%
20%
30%
40%
50%
60%
70%
80%
90%
100%
This product is "very
sasfying" or "sasfying"
Would you recommend
this product?
Would you buy this
product?
stcejbus fo %
Time (days)
KDC CYS PLA
Figure 6: Self-assessment questionnaire. (a) Hair self-assessment questionnaire output. (b) Nail self-assessment questionnaire output. (c) Overall Self-assessment.
Citation: Nobile V, Duperray J, Cestone E, Sergheraert R, Tursi F (2019) Efcacy and Safety of L-Cystine Associated or not to a Natural Keratin
(Kera-Diet®) Hydrolysate on Hair and Nails: Randomised, Placebo-Controlled, Clinical Trial on Healthy Females. J Cosmo Trichol 5: 142.
doi:10.4172/2471-9323.1000142
Volume 5 • Issue 1 • 1000142
J Cosmo Trichol, an open access journal
ISSN: 2471-9323
Page 9 of 9
generally, this study demonstrates that L-Cystine alone or a mix Kera-
Diet®+L-Cystine, associated with traced elements and specic vitamins
at the right dosage can enhance hair and nail conditions, even though
human nutrition is more and more balanced.
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... Keratin is among the most abundant structural proteins in humans and animals and is a potential source of variety of free amino acids and biopeptides. Different kinds of keratins have been studied for their benefits on hair, especially for temporary hair loss (acute telogen effluvium), and for nail brittleness [8][9][10]. However, the role of keratin supplementation in preventing skin aging remains broadly understudied [11]. ...
... Specifically, skin wrinkles, skin roughness, skin firmness and elasticity, skin gloss, deep skin moisturization, skin thickness, and skin fiber network were evaluated. Secondary objectives of this study were to evaluate the effect of the tested products in improving hair gloss, nail gloss, and nail hardness/aspect to confirm the efficacy observed in an initial study published in 2019 and 2021 [9,10]. ...
... FKH treatments, at 500 or 1000 mg/day, also achieved significant improvement in various hair and nail parameters, such as gloss, nail hardness, and general aspect, confirming the preliminary results of a previous clinical trial [9,10] in which a 1000 mg/day dosage of FKH including vitamins and minerals was shown to improve hair density, percentage of hair in anagen phase, hair and nail gloss, and nail growth [10]. The current study extends these results and demonstrates a significant effect of FKH, commercialized under the brand name Kera-Diet (KeraGLO in the United States) as a sole ingredient, on skin, hair, and nails with a dose of 500 mg/day. ...
Article
Full-text available
Background Keratin hydrolysates are active components used in food supplements to alleviate aging signs on skin, hair, and nails. Aims This randomized, double‐blind, placebo‐controlled study evaluates a novel keratin hydrolysate obtained from poultry feathers. This feather keratin hydrolysate (FKH) results in a characteristic mix of free L‐amino acids (≥ 83.5%). FKH was administered as a food supplement to a panel of adult women showing aging physiological signs. Methods Participants were randomly assigned in three groups to receive daily dosages of 500 or 1000 mg of FKH or placebo for 90 days. Parameters of skin roughness, wrinkle features, deep skin moisturization, skin maximum elongation and elasticity, skin thickness, skin anisotropy, skin density, gloss of skin, hair and nails, and nail hardness were evaluated. Subjects also answered a questionnaire related to the treatment efficacy perception. Results Both FKH treatments showed a significant improvement of all parameters compared to day 0 and to placebo, with an exception for fiber anisotropy and fiber density which showed a significant improvement compared to day 0 and a tendency to improve compared to placebo. These measurements were bolstered by the results of a self‐assessment questionnaire, showing an overall set of positive answers for both treatments compared to placebo. Conclusions Oral supplementation of FKH for 90 days is associated with an improvement in the appearance of facial skin, hair, and nails. This study highlights the benefits of free L‐amino acids mix as potential aminobiotics and not just as building blocks of proteins, suggesting a new perspective of nutricosmetic food.
... However, when it comes to the claims accompanying skin, hair, and nails food supplements, most of the time, they are not supported by evidence-based-science. 2,4 In a previous study, we demonstrated the effect of L-Cystine amino acid in improving hair and nail conditions. 5 Nowadays, due to the increasing evidence that protein-based dietary supplements can be effective in reducing hair loss 6 and improving nails conditions, 7 we extended our previous research to nutrients obtained from poultry feathers which composition is close to the human keratin and also highly bioavailable for the organism. As a matter of fact, the use of animal co-products in food supplementation represents an effective way to make them value-added products and to decrease their impact on the environmental pollution. ...
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... (ii) previous studies have shown that glutathione orally administered was well tolerated; 16,19 (iii) L-Cystine is an amino acid safely used as a nutrient added to foods and L-Glutathione is Generally Recognized as Safe (GRAS) by the Food and Drug Administration (FDA), for use as a food ingredient; and (iv) the daily intake doses of the two main ingredients of the investigated product (500 mg for L-Cystine and 250 mg for L-Glutathione) were far below the doses likely to induce any safety concerns. 32,33 Therefore, no safety concern was expected and the above points were the reason why no standard laboratory tests (hematology, blood chemistry, or urine analysis) were undertaken in this trial to further investigate the safety profiles of ingredients already approved as food ingredients. ...
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