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Citation: Kazimierska, K.; Erkiert-
Polguj, A.; Kalinowska-Lis, U. The
Efficacy of a Cosmetic Preparation
Containing Sheep Colostrum on
Mature Skin: A Randomized
Placebo-Controlled Double-Blind
Study. Appl. Sci. 2024,14, 2862.
https://doi.org/10.3390/
app14072862
Academic Editors: JoséMachado
and Jinchul Kim
Received: 8 January 2024
Revised: 14 February 2024
Accepted: 26 March 2024
Published: 28 March 2024
Copyright: © 2024 by the authors.
Licensee MDPI, Basel, Switzerland.
This article is an open access article
distributed under the terms and
conditions of the Creative Commons
Attribution (CC BY) license (https://
creativecommons.org/licenses/by/
4.0/).
applied
sciences
Article
The Efficacy of a Cosmetic Preparation Containing Sheep
Colostrum on Mature Skin: A Randomized Placebo-Controlled
Double-Blind Study
Kinga Kazimierska 1, Anna Erkiert-Polguj 2and Urszula Kalinowska-Lis 1, *
1Department of Cosmetic Raw Materials Chemistry, Faculty of Pharmacy, Medical University of Lodz,
90-419 Łód´z, Poland; kinga.kazimierska@stud.umed.lodz.pl
2Department of Cosmetology and Aesthetic Dermatology, Faculty of Pharmacy, Medical University of Lodz,
90-419 Łód´z, Poland; anna.erkiert-polguj@umed.lodz.pl
*Correspondence: urszula.kalinowska-lis@umed.lodz.pl
Abstract: Colostrum, the first milk produced by mammals, is rich in various bioactive components
that provide numerous health benefits to newborns, such as growth factors, hormones, immunoglob-
ulins, cytokines, and enzymes. Topical application of bovine or equine colostrum has been found
to improve regeneration, accelerate cutaneous wound healing, and have moisturizing, protective,
and anti-aging properties. The aim of this study was to examine the effect of a cosmetic prepara-
tion containing sheep colostrum on skin with signs of aging in mature women. Fifty-two women,
aged 40–70, were randomized into two groups to receive either colostrum or placebo cream. The
participants applied the cream for eight weeks. Skin hydration, TEWL, sebum, erythema, and tone
were measured using a standardized Courage + Khazaka electronic GmbH Multi Probe Adapter; skin
elasticity was measured with a cutometer, and images were taken by FotoMedicus. The treatment
increased skin moisture, reduced TEWL, and improved skin firmness. These findings were confirmed
by the subjective survey. The participants reported, inter alia, improved skin softness and less red-
ness and hypersensitivity. Sheep colostrum cream was more effective at improving skin conditions
than placebo cream. Colostrum creams can improve certain aspects of skin quality, especially the
hydrolipid barrier, and overall rejuvenation.
Keywords: colostrum; skin; hydration; TEWL; firmness; mature skin; placebo-controlled
1. Introduction
As people age, their skin undergoes changes that result in reduced dermal hydration,
elasticity, thickness, and density. These changes can be caused by various factors, including
genetics and lifestyle, as well as environmental factors such as sun exposure, pollution, and
smoking. As a result, there is a growing interest in the use of natural products to improve
skin health [1].
Colostrum is the first milk produced by humans and other mammals after giving birth.
It is rich in various bioactive components, such as growth factors, hormones, immunoglob-
ulins, cytokines, and enzymes, which provide numerous health benefits to newborns.
Colostrum contains high levels of insulin-like growth factor-1 (IGF-1), which stimulates cell
growth and differentiation, and epidermal growth factor (EGF), which promotes the growth
and repair of skin tissue. Additionally, colostrum contains several other growth factors
that have been shown to play a crucial role in skin regeneration and repair, including trans-
forming growth factor-beta (TGF-
β
), platelet-derived growth factor (PDGF), and fibroblast
growth factor (FGF) [
2
,
3
]. In addition to its growth factor content, colostrum also contains
several other bioactive components that provide various health benefits. For example, it
contains lactoferrin, which has antibacterial, antiviral, and anti-inflammatory properties,
and has been shown to promote wound healing. Colostrum also contains proline-rich
Appl. Sci. 2024,14, 2862. https://doi.org/10.3390/app14072862 https://www.mdpi.com/journal/applsci
Appl. Sci. 2024,14, 2862 2 of 13
polypeptides (PRPs), which modulate the immune system and have been shown to improve
skin barrier function [4].
Most of the studies concerning dairy foods have focused on bovine milk, the most
common milk used in human nutrition. However, sheep colostrum contains higher levels
of various bioactive molecules, such as immunoglobulins and growth factors, compared
to bovine colostrum [
5
,
6
]. For example, sheep colostrum has been shown to have higher
levels of insulin-like growth factor 1 (IGF-1), which plays a crucial role in tissue repair
and regeneration [7].
Several studies have confirmed that colostrum influences skin health. Topical applica-
tion of bovine colostrum improved skin regeneration and accelerated cutaneous wound
healing [
8
]. Bovine colostrum promotes wound healing and reduces scar formation in
rats [
9
]. Subsequent research suggests that exosomes sourced from bovine colostrum
possess remarkable structural and functional stability, making them a promising natural
remedy for mending age-related and sun-induced skin injuries [10].
One study found a cosmetic preparation containing a mixture of horse colostrum and
horse milk to demonstrate a number of benefits for healthy and diseased skin. The effects
included various anti-aging, moisturizing, protective, and smoothing effects, as well as
pain relief, greater skin tension, and epithelial regeneration. It was found to be suitable for
both healthy and diseased skin [11].
However, little is known about the effect of sheep colostrum on the skin. Therefore,
the aim of the present study was to examine the effects of a cosmetic preparation containing
15% sheep colostrum lyophilizate on skin with signs of aging.
2. Results
2.1. Instrumental Measurement of Skin Parameters
The corneometry test demonstrated a statistically significant enhancement of skin
hydration in the group receiving the cream with sheep colostrum (the colostrum cream
group): mean skin hydration increased substantially from 35.9 to 51.1 units (Figure 1,
Table 1). In contrast, in the placebo group receiving the cream without colostrum (placebo
group), only a slight, insignificant change in hydration was noted (from 42.2 to 46.2 units).
Appl.Sci.2024,14,xFORPEERREVIEW2of14
anti‐inflammatoryproperties,andhasbeenshowntopromotewoundhealing.Colos‐
trumalsocontainsproline‐richpolypeptides(PRPs),whichmodulatetheimmunesys‐
temandhavebeenshowntoimproveskinbarrierfunction[4].
Mostofthestudiesconcerningdairyfoodshavefocusedonbovinemilk,themost
commonmilkusedinhumannutrition.However,sheepcolostrumcontainshigherlevels
ofvariousbioactivemolecules,suchasimmunoglobulinsandgrowthfactors,compared
tobovinecolostrum[5,6].Forexample,sheepcolostrumhasbeenshowntohavehigher
levelsofinsulin‐likegrowthfactor1(IGF‐1),whichplaysacrucialroleintissuerepair
andregeneration[7].
Severalstudieshaveconfirmedthatcolostruminfluencesskinhealth.Topicalap‐
plicationofbovinecolostrumimprovedskinregenerationandacceleratedcutaneous
woundhealing[8].Bovinecolostrumpromoteswoundhealingandreducesscarfor‐
mationinrats[9].Subsequentresearchsuggeststhatexosomessourcedfrombovineco‐
lostrumpossessremarkablestructuralandfunctionalstability,makingthemapromising
naturalremedyformendingage‐relatedandsun‐inducedskininjuries[10].
Onestudyfoundacosmeticpreparationcontainingamixtureofhorsecolostrum
andhorsemilktodemonstrateanumberofbenefitsforhealthyanddiseasedskin.The
effectsincludedvariousanti‐aging,moisturizing,protective,andsmoothingeffects,as
wellaspainrelief,greaterskintension,andepithelialregeneration.Itwasfoundtobe
suitableforbothhealthyanddiseasedskin[11].
However,lileisknownabouttheeffectofsheepcolostrumontheskin.Therefore,
theaimofthepresentstudywastoexaminetheeffectsofacosmeticpreparationcon‐
taining15%sheepcolostrumlyophilizateonskinwithsignsofaging.
2.Results
2.1.InstrumentalMeasurementofSkinParameters
Thecorneometrytestdemonstratedastatisticallysignificantenhancementofskin
hydrationinthegroupreceivingthecreamwithsheepcolostrum(thecolostrumcream
group):meanskinhydrationincreasedsubstantiallyfrom35.9to51.1units(Figure1,
Table1).Incontrast,intheplacebogroupreceivingthecreamwithoutcolostrum(pla‐
cebogroup),onlyaslight,insignificantchangeinhydrationwasnoted(from42.2to46.2
units).
Inordertoaccuratelydescribethisskinparameter,themedianandtheinterquartile
range(median(25%;75%))ofthepercentageofchangesbetweenthefirstandsecond
measurementsforbothgroupswerecalculated(Table2).Theresultsindicateasignifi‐
cantlyhigherchanceofimprovingskinhydrationinthecolostrumcreamgroup(45.5%),
comparedtotheplacebogroup(9.5%).
Figure1.Skinhydrationbeforeandaftertreatmentinthecolostrumcreamandplacebogroups;***
p<0.0001.
Figure 1. Skin hydration before and after treatment in the colostrum cream and placebo groups;
*** p< 0.0001.
In order to accurately describe this skin parameter, the median and the interquartile
range (median (25%; 75%)) of the percentage of changes between the first and second
measurements for both groups were calculated (Table 2). The results indicate a significantly
higher chance of improving skin hydration in the colostrum cream group (45.5%), compared
to the placebo group (9.5%).
Appl. Sci. 2024,14, 2862 3 of 13
Table 1. Changes in skin parameters after eight weeks of treatment in the colostrum cream and
placebo groups, expressed as mean ±SD.
Skin Parameter Group Measurement I
(Week 0)
Measurement II
(Week 8)
Statistical
Significance (p)
Hydration Colostrum cream (n = 30) 35.9 ±11.8 [U] 51.1 ±10.7 [U] p< 0.0001
Placebo (n = 18) 42.2 ±11.9 [U] 46.2 ±8.3 [U] NS (p= 0.147)
TEWL Colostrum cream (n = 30) 21.1 ±12.3 [U] 15.3 ±5.4 [U] p= 0.021
Placebo (n = 16) 20.8 ±9.0 [U] 16.1 ±6.2 [U] p= 0.030
Erythema Colostrum cream (n = 30) 351.9 ±83.2 [U] 361.6 ±92.5 [U] NS (p= 0.254)
Placebo (n = 18) 336.2 ±78.1 [U] 359.0 ±82.1 [U] NS (p= 0.115)
Melanian content Colostrum cream (n = 30) 111.7 ±33.7 [U] 109.8 ±33.3 [U] NS (p= 0.520)
Placebo (n = 18) 107.6 ±31.0 [U] 104.5 ±26.1 [U] NS (p= 0.517)
Sebum Colostrum cream (n = 28) 40.9 ±35.0 [U] 39.0 ±26.2 [U] NS (p= 0.684)
Placebo (n = 18) 42.1 ±35.5 [U] 39.7 ±27.8 [U] NS (p= 0.689)
Firmness R0 Colostrum cream (n = 29) 0.201 ±0.026 [U] 0.177 ±0.021 [U] p< 0.0001
Placebo (n = 16) 0.207 ±0.029 [U] 0.177 ±0.031 [U] p= 0.001
Firmness F0 Colostrum cream (n = 29) 32.6 ±4.6 [U] 27.1 ±3.0 [U] p< 0.0001
Placebo (n = 16) 31.6 ±4.1 [U] 26.7 ±3.5 [U] p< 0.0001
Table 2. Percentage changes in skin parameters over the course of treatment in the colostrum cream
and placebo groups, expressed as median and interquartile range, i.e., median (25%; 75%).
Skin Parameter
Colostrum Cream Group
Placebo Group Statistical
Significance (p)
Hydration 45.5 (12.3; 82.0) [%] 9.5 (−15.0; 34.3) [%] p= 0.008
TEWL −18.2 (−34.1; 2.8) [%] −19.1 (−40.6; 2.9) [%] NS (p= 0.854)
Erythema 4.6 (−5.2; 10.0) [%] 2.3 (−5.0; 13.4) [%] NS (p= 0.823)
Melanin content −3.5 (−10.0; 7.4) [%] 0.6 (−16.8; 12.1) [%] NS (p= 0.865)
Sebum 5.4 (−34.6; 99.5) [%] −6.1 (−38.1; 100.8) [%] NS (p= 0.536)
Firmness R0 −10.8 (−17.6; −5.7) [%] −15.7 (−23.5; −4.8) [%] NS (p= 0.448)
Firmness F0 −17.2 (−25.5; −5.1) [%] −15.9 (−24.7; −6.7) [%] NS (p= 0.652)
The two groups demonstrated similar mean TEWL values before the application of
the creams: viz., colostrum 21.1 g/h/m
2
and placebo 20.8 g/h/m
2
. After eight weeks
of treatment, the TEWL values in both groups improved by about five units, i.e., from a
normal level (15–25 g/h/m
2
) to a healthy condition (10–15 g/h/m
2
) [
12
]. These changes
were statistically significant in both groups, p< 0.05 (Figure 2, Table 1).
Skin firmness, assessed by the R0 and F0, improved in both groups over the course of
the experiment. R0 represents the passive response of the skin to force, and F0 represents
the firmness of the skin at the time of suction [
13
,
14
]. Mean R0 values decreased from
0.201 to 0.177 units in the colostrum cream group and from 0.207 to 0.177 units in the placebo
group (Figure 3, Table 1). Similarly, mean F0 values decreased from 32.6 to 27.1 units in
the colostrum cream group and from 31.6 to 26.7 units in the placebo group (p< 0.001)
(Figure 4, Table 1).
No significant changes in erythema, melanin content, or sebum were observed at
the end of this study in either the colostrum cream or placebo groups. Detailed data are
presented in Tables 1and 2.
Appl. Sci. 2024,14, 2862 4 of 13
Appl.Sci.2024,14,xFORPEERREVIEW3of14
Tabl e1.Changesinskinparametersaftereightweeksoftreatmentinthecolostrumcreamand
placebogroups,expressedasmean±SD.
SkinParameterGroupMeasurementI
(Week0)
MeasurementII
(Week8)
Statistical
Significance(p)
HydrationColostrumcream(n=30)35.9±11.8[U]51.1±10.7[U]p<0.0001
Placebo(n=18)42.2±11.9[U]46.2±8.3[U]NS(p=0.147)
TEWLColostrumcream(n=30)21.1±12.3[U]15.3±5.4[U]p=0.021
Placebo(n=16)20.8±9.0[U]16.1±6.2[U]p=0.030
ErythemaColostrumcream(n=30)351.9±83.2[U]361.6±92.5[U]NS(p=0.254)
Placebo(n=18)336.2±78.1[U]359.0±82.1[U]NS(p=0.115)
MelaniancontentColostrumcream(n=30)111.7±33.7[U]109.8±33.3[U]NS(p=0.520)
Placebo(n=18)107.6±31.0[U]104.5±26.1[U]NS(p=0.517)
SebumColostrumcream(n=28)40.9±35.0[U]39.0±26.2[U]NS(p=0.684)
Placebo(n=18)42.1±35.5[U]39.7±27.8[U]NS(p=0.689)
FirmnessR0Colostrumcream(n=29)0.201±0.026[U]0.177±0.021[U]p<0.0001
Placebo(n=16)0.207±0.029[U]0.177±0.031[U]p=0.001
FirmnessF0Colostrumcream(n=29)32.6±4.6[U]27.1±3.0[U]p<0.0001
Placebo(n=16)31.6±4.1[U]26.7±3.5[U]p<0.0001
Tabl e2.Percentagechangesinskinparametersoverthecourseoftreatmentinthecolostrumcream
andplacebogroups,expressedasmedianandinterquartilerange,i.e.,median(25%;75%).
SkinParameter ColostrumCream
Group PlaceboGroupStatisticalSignifi‐
cance(p)
Hydration45.5(12.3;82.0)[%]9.5(−15.0;34.3)[%]p=0.008
TEWL−18.2(−34.1;2.8)[%]−19.1(−40.6;2.9)[%]NS(p=0.854)
Erythema4.6(−5.2;10.0)[%]2.3(−5.0;13.4)[%]NS(p=0.823)
Melanincontent−3.5(−10.0;7.4)[%]0.6(−16.8;12.1)[%]NS(p=0.865)
Sebum5.4(−34.6;99.5)[%]−6.1(−38.1;100.8)[%]NS(p=0.536)
FirmnessR0−10.8(−17.6;−5.7)[%]−15.7(−23.5;−4.8)[%]NS(p=0.448)
FirmnessF0−17.2(−25.5;−5.1)[%]−15.9(−24.7;−6.7)[%]NS(p=0.652)
ThetwogroupsdemonstratedsimilarmeanTEWLvaluesbeforetheapplicationof
thecreams:viz.,colostrum21.1g/h/m
2
andplacebo20.8g/h/m
2
.Aftereightweeksof
treatment,theTEWLvaluesinbothgroupsimprovedbyaboutfiveunits,i.e.,froma
normallevel(15–25g/h/m
2
)toahealthycondition(10–15g/h/m
2
)[12].Thesechanges
werestatisticallysignificantinbothgroups,p<0.05(Figure2,Table1).
Figure 2. TEWL before and after treatment in the colostrum cream and placebo groups; * p< 0.05.
Appl.Sci.2024,14,xFORPEERREVIEW4of14
Figure2.TEWLbeforeandaftertreatmentinthecolostrumcreamandplacebogroups;*p<0.05.
Skinfirmness,assessedbytheR0andF0,improvedinbothgroupsoverthecourse
oftheexperiment.R0representsthepassiveresponseoftheskintoforce,andF0repre‐
sentsthefirmnessoftheskinatthetimeofsuction[13,14].MeanR0valuesdecreased
from0.201to0.177unitsinthecolostrumcreamgroupandfrom0.207to0.177unitsin
theplacebogroup(Figure3,Table1).Similarly,meanF0valuesdecreasedfrom32.6to
27.1unitsinthecolostrumcreamgroupandfrom31.6to26.7unitsintheplacebogroup
(p<0.001)(Figure4,Table1).
Nosignificantchangesinerythema,melanincontent,orsebumwereobservedatthe
endofthisstudyineitherthecolostrumcreamorplacebogroups.Detaileddataare
presentedinTables1and2.
Figure3.Skinfirmness(R0)beforeandaftertreatmentinthecolostrumcreamandplacebogroups;
***p<0.0001,**p<0.001.
Figure4.Skinfirmness(F0)beforeandaftertreatmentinthecolostrumcreamandplacebogroups;
***p<0.0001.
2.2.Photodocumentation
Itisimportanttonotethattheresearchersassessedblindedphotostheydidnot
knowwhetherthesubjectsbelongedtotheplacebogrouporthecolostrumcreamgroup.
Significantintergroupdifferenceswerefoundforreductioninrednessand
smoothingofskinpores,p<0.05.Assumingascoreof4,3,or2indicatedimprovement,
and1or0indicatednoimprovement(Figure5),improvedrednesswasobservedby
25.0%inthecolostrumcreamgroupand0%intheplacebogroup,andimproved
smoothingofskinporeswasobservedin71.4%ofcolostrumand38.9%inplacebo.
Figure 3. Skin firmness (R0) before and after treatment in the colostrum cream and placebo groups;
*** p< 0.0001, ** p< 0.001.
Appl.Sci.2024,14,xFORPEERREVIEW4of14
Figure2.TEWLbeforeandaftertreatmentinthecolostrumcreamandplacebogroups;*p<0.05.
Skinfirmness,assessedbytheR0andF0,improvedinbothgroupsoverthecourse
oftheexperiment.R0representsthepassiveresponseoftheskintoforce,andF0repre‐
sentsthefirmnessoftheskinatthetimeofsuction[13,14].MeanR0valuesdecreased
from0.201to0.177unitsinthecolostrumcreamgroupandfrom0.207to0.177unitsin
theplacebogroup(Figure3,Table1).Similarly,meanF0valuesdecreasedfrom32.6to
27.1unitsinthecolostrumcreamgroupandfrom31.6to26.7unitsintheplacebogroup
(p<0.001)(Figure4,Table1).
Nosignificantchangesinerythema,melanincontent,orsebumwereobservedatthe
endofthisstudyineitherthecolostrumcreamorplacebogroups.Detaileddataare
presentedinTables1and2.
Figure3.Skinfirmness(R0)beforeandaftertreatmentinthecolostrumcreamandplacebogroups;
***p<0.0001,**p<0.001.
Figure4.Skinfirmness(F0)beforeandaftertreatmentinthecolostrumcreamandplacebogroups;
***p<0.0001.
2.2.Photodocumentation
Itisimportanttonotethattheresearchersassessedblindedphotostheydidnot
knowwhetherthesubjectsbelongedtotheplacebogrouporthecolostrumcreamgroup.
Significantintergroupdifferenceswerefoundforreductioninrednessand
smoothingofskinpores,p<0.05.Assumingascoreof4,3,or2indicatedimprovement,
and1or0indicatednoimprovement(Figure5),improvedrednesswasobservedby
25.0%inthecolostrumcreamgroupand0%intheplacebogroup,andimproved
smoothingofskinporeswasobservedin71.4%ofcolostrumand38.9%inplacebo.
Figure 4. Skin firmness (F0) before and after treatment in the colostrum cream and placebo groups;
*** p< 0.0001.
Appl. Sci. 2024,14, 2862 5 of 13
2.2. Photodocumentation
It is important to note that the researchers assessed blinded photos they did not know
whether the subjects belonged to the placebo group or the colostrum cream group.
Significant intergroup differences were found for reduction in redness and smoothing
of skin pores, p< 0.05. Assuming a score of 4, 3, or 2 indicated improvement, and 1 or 0
indicated no improvement (Figure 5), improved redness was observed by 25.0% in the
colostrum cream group and 0% in the placebo group, and improved smoothing of skin
pores was observed in 71.4% of colostrum and 38.9% in placebo.
Appl.Sci.2024,14,xFORPEERREVIEW5of14
Figure5.Comparisonoftheresultsofphotodocumentationbetweenthecolostrumcreamand
placebogroups.
Inthecolostrumcreamgroup,majorimprovementswerenotedin“overallim‐
provement”,notedby71.4%ofparticipants,and“skintonealignment”,notedby53.6%.
Itisworthemphasizingthatforeachconsideredparameter,agreaterimprovement
wasobservedinthecolostrumcreamgroupthanintheplacebogroup.
Exemplarypicturesofsubjectsbefore(left)andafter(right)eightweeksofusingthe
colostrumcreamwasshowninFigureS1.
2.3.SubjectiveAssessmentofSkinParameters
Theresultsofthesubjectiveassessmentofskinparameterswerepresentedasthe
percentageofsubjectswhoseskinimproved,worsened,orremainedunchanged(Figure
6).Overall,moresubjectsinthecolostrumcreamgroupnotedanimprovementinskin
condition(27.6–55.2%)thanintheplacebogroup(17.6–40.0%).Inthecolostrumcream
group,about50%ofthesubjectsreportedanimprovementinskinhydration,regenera‐
tion,andsoftness,aswellasareductioninrednessandskinhypersensitivity.Astatisti‐
callysignificant(p<0.05)differenceinsoftnesswasfoundbetweenthecolostrumcream
andplacebogroups.Thesubjectiveandobjectivemeasurementsobtainedsimilarresults
intermsofskinhydrationandelasticity.
Amongthecolostrumcreamgroup,threesubjectswithoilyskinreportedreduced
sebumsecretionaftertreatment.Indeed,theseobservationswereconsistentwiththe
recordedsebummeasurements,whichimprovedfrom126unitsto76unitsinonepar‐
ticipant,andfrom142to100unitsand150to102unitsintheothers.
Figure 5. Comparison of the results of photo documentation between the colostrum cream and
placebo groups.
In the colostrum cream group, major improvements were noted in “overall improve-
ment”, noted by 71.4% of participants, and “skin tone alignment”, noted by 53.6%.
It is worth emphasizing that for each considered parameter, a greater improvement
was observed in the colostrum cream group than in the placebo group.
Exemplary pictures of subjects before (left) and after (right) eight weeks of using the
colostrum cream was shown in Figure S1.
2.3. Subjective Assessment of Skin Parameters
The results of the subjective assessment of skin parameters were presented as the
percentage of subjects whose skin improved, worsened, or remained unchanged (Figure 6).
Overall, more subjects in the colostrum cream group noted an improvement in skin condi-
tion (27.6–55.2%) than in the placebo group (17.6–40.0%). In the colostrum cream group,
about 50% of the subjects reported an improvement in skin hydration, regeneration, and
softness, as well as a reduction in redness and skin hypersensitivity. A statistically signifi-
cant (p< 0.05) difference in softness was found between the colostrum cream and placebo
groups. The subjective and objective measurements obtained similar results in terms of
skin hydration and elasticity.
Among the colostrum cream group, three subjects with oily skin reported reduced se-
bum secretion after treatment. Indeed, these observations were consistent with the recorded
sebum measurements, which improved from 126 units to 76 units in one participant, and
from 142 to 100 units and 150 to 102 units in the others.
Appl. Sci. 2024,14, 2862 6 of 13
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Figure 6. Cont.
Appl. Sci. 2024,14, 2862 7 of 13
Appl.Sci.2024,14,xFORPEERREVIEW7of14
Figure6.Changesinsubjectiveevaluationofskinparameters;placebogroupinthecenterring;
colostrumcreamgroupintheouterring.
2.4.SideEffectsoftheCreamsUsed
Threesubjectsinthecolostrumcreamgroupandtwosubjectsintheplacebogroup
reportedsideeffectssuchasdrynessandtightnessoftheskin,skinredness,andaburn‐
ingsensation.Thesesymptomssubsidedafteradozenorsominutesafterapplyingthe
creams.Presumably,theywererelatedtothefragrancepresentinbothpreparations.It
wasunlikelythatthecolostrumwasresponsible,assideeffectswerenotedinboththe
colostrumandplacebogroups.
Ofthe52subjectsinthisstudy,twofromtheplacebogroupwerelosttofollow‐up
forvariousreasonsotherthanthetreatment,andanothertwofromthecolostrumcream
groupduetoadverseeffects(skindrynessandirritation).
3.Discussion
Ourstudydescribesapreliminaryevaluationoftheuseofcosmeticcreamcontain‐
ing15%sheepʹscolostrumlyophilizateonmatureskincomparedtoplacebocream.
Inastudyof15healthyvolunteers,nanoliposomesencapsulatedwithskimmed
donkeymilkcreamsdemonstratedgoodresultsinhydrationandepidermalwaterloss
improvement,althoughtheeffectswerenotsignificantlybeerthanplacebocream.Our
researchwasconductedonamuchlargergroup(forty‐eightwomenfinishedthestudy),
andincomparisontoplacebocream,thecolostrumonewassignificantlybeerathy‐
drationimprovement[15].
Inaddition,insevenpatientswithmoderateatopicdermatitis,a20%horsecolos‐
trumemulsionwasfoundtodemonstrategreatersoftening,moisturizing,soothing,and
anti‐inflammatoryeffectsthancommonlyavailableemulsionswhenappliedtwicedaily
for30days;inaddition,thetreatmentresultedinreducederythemaandpruritus,with
noobservedsideeffects[11].Furthermore,cosmeticformulationscombininghorseco‐
lostrumandhorsemilkdemonstratedvariousbenefits,includinganti‐aging,moisturiz‐
ing,protective,tensio‐distensive,tonic,smoothing,anti‐irritant,emollient,bleaching,
decongestant,andsebostaticactivities[11,16].
Lastly,productsconsistingofbovineorequinecolostrum,hyaluronicacidoritssalt,
andinteraliaoliveoil(Oleaeuropea)orvitaminEwerefoundtoreduceskinaging,im‐
proveskinelasticityandtension,anddemonstratemoisturizingandantioxidantproper‐
tiesinthefacialskinofelderlyparticipants[16].
Figure 6. Changes in subjective evaluation of skin parameters; placebo group in the center ring;
colostrum cream group in the outer ring.
2.4. Side Effects of the Creams Used
Three subjects in the colostrum cream group and two subjects in the placebo group
reported side effects such as dryness and tightness of the skin, skin redness, and a burning
sensation. These symptoms subsided after a dozen or so minutes after applying the creams.
Presumably, they were related to the fragrance present in both preparations. It was unlikely
that the colostrum was responsible, as side effects were noted in both the colostrum and
placebo groups.
Of the 52 subjects in this study, two from the placebo group were lost to follow-up for
various reasons other than the treatment, and another two from the colostrum cream group
due to adverse effects (skin dryness and irritation).
3. Discussion
Our study describes a preliminary evaluation of the use of cosmetic cream contain-
ing 15% sheep’s colostrum lyophilizate on mature skin compared to placebo cream.
In a study of 15 healthy volunteers, nanoliposomes encapsulated with skimmed
donkey milk creams demonstrated good results in hydration and epidermal water loss
improvement, although the effects were not significantly better than placebo cream. Our
research was conducted on a much larger group (forty-eight women finished the study),
and in comparison to placebo cream, the colostrum one was significantly better at hydration
improvement [15].
In addition, in seven patients with moderate atopic dermatitis, a 20% horse colostrum
emulsion was found to demonstrate greater softening, moisturizing, soothing, and anti-
inflammatory effects than commonly available emulsions when applied twice daily for 30 days;
in addition, the treatment resulted in reduced erythema and pruritus, with no observed
side effects [
11
]. Furthermore, cosmetic formulations combining horse colostrum and horse
milk demonstrated various benefits, including anti-aging, moisturizing, protective, tensio-
distensive, tonic, smoothing, anti-irritant, emollient, bleaching, decongestant, and sebostatic
activities [11,16].
Lastly, products consisting of bovine or equine colostrum, hyaluronic acid or its salt,
and inter alia olive oil (Olea europea) or vitamin E were found to reduce skin aging, improve
skin elasticity and tension, and demonstrate moisturizing and antioxidant properties in the
facial skin of elderly participants [16].
Appl. Sci. 2024,14, 2862 8 of 13
Hence, colostrum-based creams appear to effectively promote skin health. The in-
creased skin hydration observed in our colostrum group can be attributed to the high levels
of lipids, growth factors, vitamins, and minerals in sheep colostrum, which are present in
greater amounts than in colostrum bovium. These substances promote the hydration, and
nourishment of the skin [
17
,
18
]. The product also has a positive effect on skin hydration;
the fatty acids in colostrum have beneficial effects on skin barrier function, manifested as a
reduction in TEWL. Various miristic, palmitic, stearic, palmitoleic, oleic, and linoleic fatty
acids are distributed throughout the stratum corneum. It is important to emphasize that
while all acids are present in colostrum in high amounts, palmitic acid is both the main FFA
in the epidermis and in the colostrum used in this study [19].
Our findings indicate a significantly better reduction in redness and improved smooth-
ing of skin pores in the colostrum than in the placebo group. Also, the colostrum group
reported better effects in the survey, including shallower wrinkles, softer skin, and lower
hypersensitivity. Similarly, skin firmness was found to objectively improve, as measured
by the cutometer.
The beneficial regenerative properties of colostrum could be due to the effects of its
ingredients on fibroblasts or their antioxidative properties. Previous bovine colostrum
studies noted increased fibroblast proliferation and migration and a slower telomere short-
ening rate, indicating delayed cellular aging. Under conditions of oxidative stress
in vitro
,
colostrum appears to exert a protective effect against telomere length erosion and oxidative
stress, thus preventing skin inflammation and textural changes [20,21].
In the context of the discussed study, it is worth mentioning the effect of colostrum
or milk of various origins on skin cell lines. In particular, bovine colostrum stimulates
keratinocyte proliferation and migration, suggesting its positive re-epithelializing effect at
the wound site [
22
]. As bovine colostrum has the ability to induce the differentiation of
keratinocytes, it may be helpful in the treatment of skin diseases characterized by impaired
barrier function, such as dry skin in the elderly or people exposed to UV radiation [
23
].
The study conducted on skin fibroblast culture shows that donkey milk may be useful in
the treatment of inflammatory skin diseases as well as in wound healing, regenerative, and
aesthetic dermatology [
24
]. Mare’s colostrum, especially its fat fraction [
25
] and bovine
colostrum [
26
], strongly stimulates the proliferation of fibroblast culture. It is believed that
they may affect the effectiveness of skin wound healing.
The
in vivo
wound healing ability of multifunctional bovine colostrum-conjugated
nanofibrous dressings was confirmed in a rat wound model. Probably, high levels of
immunoglobulins, lactoferrin, hormones, and cytokines played a significant role in wound
healing [27].
Consideration should also be given to reports on the oral supplementation of dairy
substances and products. Routine four-week intake of fermented milk products loaded with
various lactic acid bacteria strains resulted in increased skin hydration [
28
]. Other evidence
suggests that continuous supplementation with sphingomyelin (SM), a phospholipid found
in milk fat globules, has the potential to boost skin hydration and elasticity [29].
An oral formula with high levels of milk proteins, growth factors, alpha-lactalbumin,
lactoferrin, and immunoglobulins was found to diminish skin lesions in individuals with
plaque psoriasis [30]. The same proteins are present in sheep colostrum [3].
An oral administration of bovine lactoferrin prevented transepidermal water loss, ir-
regular epidermal thickening, cell apoptosis, and increased skin hydration in UVB-radiated
hairless mice [31].
Many of the health-promoting effects on human skin have been attributed to the vitamins,
minerals, and amino acids present in bovine colostrum [
32
]. Collagen production, wound
healing, and antioxidant activity are believed to be supported by ascorbic acid (vitamin
C), niacin (B3), biotin (B7), vitamin E, and retinol (A), while minerals like zinc and copper
contribute to neutralizing free radicals and tissue regeneration. In addition, various amino
acids, such as proline, threonine, methionine, and arginine, also promote skin health by
Appl. Sci. 2024,14, 2862 9 of 13
supporting anti-aging and wound healing activities [
32
]. It is also important to emphasize
that sheep colostrum is as rich in minerals as bovine colostrum, and richer in protein [3].
Although toxicological studies on our raw material, sheep colostrum, have not been
assessed, they were carried out on colostrum of bovine origin. Toxicological evaluations of
an ultrafiltered bovine colostrum product, i.e., a mixture of native colostrum and a unique
subset of concentrated low-molecular-weight proteins (
≤
10 kDa), confirmed its safety [
33
].
Studies on rats fed for 90 days with food enriched with 3% and 10% bovine colostrum also
confirmed the safety of the colostrum, as no biochemical, physical, or histopathological
abnormalities were observed in rats [
34
]. It is worth mentioning that before conducting this
eight-week study on volunteers, the potential sensitizing and irritating effects of our cream
with 15% sheep colostrum were tested on a group of 25 people. The results of this study
showed that the cosmetic preparation did not cause any side effects in dermatological tests.
Side effects of topical use colostrum can be the result of an allergy to colostrum compo-
nents. Anaphylaxis after a cream with bovine colostrum was described [
35
], but what is worth
noticing is that sheep milk is characterized by a lower content of frequent allergens [3,36].
4. Materials and Methods
The research was registered at clinicaltrials.gov, where it received the identifier:
NCT06305923.
4.1. Preparation of Cosmetic Formulations: Colostrum Cream and Placebo Cream
4.1.1. Colostrum Raw Material
The raw material was collected within the first 24 h after the birth of the sheep, then
frozen and lyophilized. The manufacturing process of sheep colostrum was based on
rigorous quality control protocols to ensure the safety and efficacy of the end product,
making it suitable for various applications, including skincare.
4.1.2. Colostrum Cream
The formulation of the cream was developed specifically for this study. The content of
individual components is described in Table 3. The formulation used in this study is an
O/W type emulsion.
Table 3. Cosmetic formulation of the cream based on sheep colostrum.
Phase INCI Name Function Percentage
IA Aqua Solvent Till 100.0
Acrylates/C10–30 alkyl Acrylate Crosspolymer Thickener 0.2
IB Pentylene Glycol Humectant, maintenance booster 3.0
II
Isononyl Isononanoate Emollient 7.0
Cetearyl Olivate, Sorbitan Olivate Emulsifier 4.5
Glyceryl Stearate Citrate Co-emulsifier 2.0
Tripelargonin Emollient 7.0
Helianthus Annus Seed Oil, Tocopherol Antioxidant 0.1
III
Parfum Fragrance 0.7
Colostrum Active ingredient 15.0
Aqua, Sodium Lactate Humectant, pH regulator 0.5
Aqua, Potassium Sorbate, Sodium Benzonate Preservative 1.5
IV Aqua, Citric Acid pH regulator 1.3–1.5
A water phase (I) was prepared as follows: the thickening agent (Acrylates/C10–30
alkyl Acrylate Crosspolymer) was sprinkled into the water, left to ensure complete wetting,
and then mixed; it was then heated to 70–75 ◦C and entered phase IB (Pentylene Glycol).
The ingredients of fatty phase II were then heated to 75
◦
C and mixed to obtain a
homogeneous liquid. Phase II was combined with phase I and homogenized under vacuum.
Appl. Sci. 2024,14, 2862 10 of 13
After the mixture cooled to below 40
◦
C, the phase III ingredients, including the active
ingredient, colostrum, were added successively with continuous mixing. Finally, citric acid
solution (phase IV) was added to adjust the pH to the range of 4.7–5.2.
4.1.3. Placebo Cream
The placebo cream was prepared using the same process and ingredients as the colostrum
cream, but without the colostrum. Its composition included: Aqua, Acrylates/C10–30 Alkyl
Acrylate Crosspolymer, Pentylene Glycol, Isononyl Isononanoate, Cetearyl Olivate, Sorbitan
Olivate, Tripelargonin, Helianthus Annuus Seed Oil, Tocopherol, Parfum, Aqua, Sodium
Lactate, Aqua, Potassium Sorbate, Sodium Benzoate, Aqua, and Citric Acid.
The resulting products were subjected to a series of tests in accordance with the
requirements of Regulation (EC) No. 1223/2009 of the European Parliament and of the
Council of 30 November 2009 on cosmetic products by an accredited laboratory. The
scope of testing includes microbiological purity testing, testing of the effectiveness of the
preservative system used, stability and compatibility testing with packaging, as well as
dermatological testing (semi-open test). The tests confirmed the safety of the products,
which have been approved for use in humans.
4.2. Selection of Participants
The research was carried out on a group of 52 healthy volunteers, selected in accordance
with the guidelines of the Helsinki Declaration of 1964, with subsequent additions and with the
approval of the Bioethics Committee of the Medical University of Lodz No. RNN/275/21/KE
of 14 December 2021. We obtained written informed consent from each subject to participate
in this study. The inclusion and exclusion criteria are as follows in Table 4.
Table 4. Inclusion and exclusion criteria for selecting the participants.
Inclusion
Female
Age between 40 and 70
Signs of skin aging: wrinkles, loss of skin elasticity, discolorations, dryness
Signed informed consent
Exclusion
Pregnant or breastfeeding
Allergic to milk proteins
Suffer from neoplasms, contagious infections, autoimmunologic diseases
Suffer from face skin diseases
Have had an aesthetic procedure on the skin of the face during the last
two months
Have been treated with isotretinoin or other oral retinoids during the last
six months
In total, 52 subjects participated in this study. Two people from the placebo group
were lost to follow-up because of random reasons, and two from the colostrum cream
group did not complete the study due to adverse effects (dryness and irritation of the skin).
The age of the subjects who completed the study ranged from 40 to 70 years. The
mean age of the group was 50.4 years, the median was 48.0 years, and the interquartile
range (45.5, 54.0).
Participants were enrolled randomly in the colostrum cream (32 people) or placebo
groups (20 people) and were not informed which group they belonged to.
Participants were given the creams and asked to apply one –two doses in the evening
after nighttime facial cleaning. They were also asked to use sunscreen during the day.
4.3. Instrumental Measurements of Skin Parameters
During the first visit and after eight weeks of everyday use of the tested cream, the
skin parameters were measured three times on both cheeks, and the results were averaged.
The skin was measured at standardized temperature and humidity using a Courage + Khaz-
aka electronic GmbH Multi Probe Adapter with the use of the following probes:
Appl. Sci. 2024,14, 2862 11 of 13
1.
Corneometer
®
CM825 probe: measuring skin hydration based on water content in
the stratum corneum;
2. Tewameter®TM probe: assessing transepidermal water loss;
•
Mexameter
®
MX18 probe: measuring the level of hemoglobin (erythema) and
melanin, the two main dyes responsible for skin color;
•
Sebumeter
®
SM 815 probe: measuring skin sebum level, independent of
water content;
3.
Cutometer
®
MPA 580 probe: measuring the viscoelastic properties of the skin. The
R0 and F0 parameters were chosen. R0 represents the passive response of the skin to
force, lower values indicate greater firmness. F0—firmness of the skin at the time of
suction. Lower values indicate more elastic skin.
4.4. Photodocumentation
The skin was subjected to photodocumentation at the first and last visit with the use
of the Photomedicus system. The photos were taken in standard light with standardized
face positions. The photos were compared using the following scale: 0 means no improve-
ment (the same as the initial picture), 1—slight improvement, 2—moderate improvement,
3—marked improvement (marked improvement in appearance from the initial condition, but
not completely optimal), and 4—greatest possible improvement (optimal aesthetic result).
4.5. Subjective Assessment of the Skin
All participants, i.e., in both groups, subjectively assessed their skin condition after
eight weeks of treatment. Participants rated smoothing of shallow wrinkles, skin tone
alignment, regeneration, hydration, elasticity, softness, redness reduction, and hypersensi-
tivity reduction; they indicated either improvement, deterioration, or no change. Finally,
the results in each group were presented as the percentage of subjects with improved,
worsened, or unchanged skin.
4.6. Statistical Analysis
The mean and standard deviation (mean
±
SD) or median and interquartile range (me-
dian (25%; 75%)) were applied as appropriate for the description of parameters. Changes
in skin parameters compared to baseline were calculated based on the following formula:
(([x(t1)−x(t0)]/x(t0))*100).
Differences in skin parameters over time were evaluated using the paired t-test for
normally distributed data and Wilcoxon’s signed rank test for non-normal data. For unpaired
data, the t-test or Mann–Whitney test were used, depending on the distribution. The Chi-
square test, or Fisher’s exact test where appropriate, was used to compare differences between
categorical variables. pvalues of less than 0.05 were considered statistically significant.
5. Conclusions
The study of the effect of sheep colostrum cream on mature skin, in comparison
to placebo cream, is highly innovative research because no cosmetic preparation with
colostrum of sheep origin has previously been tested.
This study also indicates that the issue of preparing an appropriate placebo cream
is crucial. Our placebo product, with the same composition as our colostrum cream but
without an active component, also slightly improved hydration and TEWL in subjects.
However, the placebo cream should not improve skin condition, but on the other hand, it
should ensure comfortable application to patients throughout the study period.
Sheep colostrum cream demonstrates greater effectiveness in improving skin condi-
tions compared to placebo cream. Its use results in substantial enhancements in hydration,
TEWL, and elasticity, suggesting potential dermatological and aesthetic applications.
The subjective assessment of skin condition and photo documentation confirm the results
of the objective measurements, revealing that the colostrum cream demonstrates significant
activity in, inter alia, improving skin softness, smoothing skin pores, and reducing redness.
Appl. Sci. 2024,14, 2862 12 of 13
6. Patents
As a result of the work described in this manuscript, the Polish patent application
No. P.446801, “Cosmetic composition, method of its production, and application” was filed
on 22 November 2023.
Supplementary Materials: The following supporting information can be downloaded at: https:
//www.mdpi.com/article/10.3390/app14072862/s1, Figure S1: Exemplary pictures of subjects
before (left) and after (right) eight weeks of using the colostrum cream.
Author Contributions: Conceptualization, K.K. and U.K.-L.; methodology, A.E.-P.; formal analysis,
K.K., A.E.-P. and U.K.-L.; investigation, K.K., A.E.-P. and U.K.-L.; data curation, A.E.-P. and U.K.-L.;
writing—original draft preparation, K.K., A.E.-P. and U.K.-L.; writing—review and editing, A.E.-P.
and U.K.-L.; visualization, U.K.-L.; supervision, U.K.-L.; project administration, U.K.-L. All authors
have read and agreed to the published version of the manuscript.
Funding: This research was supported by the Medical University of Lodz, grants No. 503/3-066-
02/503-31-001 and 503/3-066-01/503-31-001.
Institutional Review Board Statement: This study was conducted according to the guidelines of the
Declaration of Helsinki and approved by the Bioethics Committee of Medical University of Lodz.
Poland (protocol code RNN/275/21/KE, date of approval 14 December 2021).
Informed Consent Statement: Informed consent was obtained from all subjects involved in this study.
Data Availability Statement: The original contributions presented in the study are included in the
article, further inquiries can be directed to the corresponding authors.
Acknowledgments: We would like to thank Łukasz Bobak from the Wroclaw University of Environ-
mental and Life Science for the lyophilization of the colostrum.
Conflicts of Interest: The authors declare no conflicts of interest.
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