Veterinary Parasitology 192 (2013) 359–364

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Veterinary Parasitology
journal homepage: www.elsevier.com/locate/vetpar

The treatment of bovine sarcoptic mange (Sarcoptes scabiei var. bovis)

using eprinomectin extended-release injection
M. Visser a,∗ , M. Löwenstein b , S. Yoon c , S. Rehbein a
a
Merial GmbH, Kathrinenhof Research Center, Walchenseestr. 8-12, 83101 Rohrdorf, Germany
b
Parasitology and Zoology, Department of Pathobiology, University of Veterinary Medicine, Veterinärplatz 1, 1210 Vienna, Austria
c
Merial Limited, 3239 Satellite Blvd., Duluth, GA 30096-4640, USA

a r t i c l e i n f o a b s t r a c t

Keywords: The efficacy of eprinomectin in an extended-release injection (ERI) formulation was eval-
Eprinomectin, macrocyclic lactone uated in cattle harbouring induced infestations of Sarcoptes scabiei var. bovis (sarcoptic
Extended-release injection
mange) in three studies conducted in Germany (two studies) and Austria (one study). A
Efficacy
total of 44 cattle were included in the studies, 12 in one study and 16 in each of the other
Mange
Sarcoptes two studies. Approximately eight weeks following initial induced infestation, cattle in each
Experimental infestation study were formed into replicates of two animals each on the basis of pre-treatment body-
Cattle weights. Within replicates the animals were randomly allocated to one of two treatments:
ERI vehicle (control) or Eprinomectin 5% (w/v) ERI (1.0 mg eprinomectin/kg). Treatments
were administered at 1 mL/50 kg bodyweight by subcutaneous injection in front of the
shoulder once on day 0. The number of live mites in skin scrapings was determined prior to
treatment and at weekly intervals for eight weeks after treatment. Severity of skin lesions
was evaluated and scored when skin scrapings were taken. In all studies, animals were
weighed before infestation and again prior to and at 56 days after treatment.
Mite counts for treated cattle were significantly (p < 0.05) lower than counts for controls
from Day 7 onwards. Cattle treated with Eprinomectin ERI were Sarcoptes mite-free from
seven, 21 or 28 days post-treatment to the end of the study in the three studies, and lesions
regressed accordingly. Mean weight gain over the post-treatment period was significantly
higher for treated cattle than for controls in two studies. All animals accepted the treatment
well.
© 2012 Elsevier B.V. Open access under CC BY-NC-ND license.

1. Introduction excoriation, marked thickening, and proliferation of the

Sarcoptic mange is caused by infestation with mites of
the species Sarcoptes scabiei. Based on adaptation to sev-
eral host species, varieties have been accepted and the mite
infesting cattle is named S. scabiei var. bovis (syn. S. bovis).
Sarcoptes mites burrow into the epidermis creating
tunnels of up to 1 cm in length, in which they feed
and reproduce. Their burrowing and feeding activities
cause inflammation and severe pruritus, loss of hair, and
∗ Corresponding author. Tel.: +49 8032 70750.
E-mail address: martin.visser@merial.com (M. Visser).
epidermal layer of the skin.
Sarcoptic mange is highly contagious and transferred by
close physical contact between animals. It tends to spread
all over the body of cattle and may result in considerable
economic losses. The intense irritation and the alteration
of the normal skin morphology and function lead to poor
weight gain and lower feed conversion efficacy, impairing
the value of the carcass, and they cause severe defects of the
hide which result in substantial devaluation of the leather.
In addition, sarcoptic mange causes disturbances in normal
behaviour with increasing levels of rubbing and scratching
and a reduction in time spent lying down (Rehbein et al.,
2003a, 2003b).

0304-4017 © 2012 Elsevier B.V. Open access under CC BY-NC-ND license.

http://dx.doi.org/10.1016/j.vetpar.2012.11.043
360 M. Visser et al. / Veterinary Parasitology 192 (2013) 359–364
Eprinomectin belongs to the avermectin subclass of the
macrocyclic lactone parasiticides (Shoop and Soll, 2002). It
has demonstrated excellent nematocidal, insecticidal and
miticidal activity against a wide range of internal and exter-
nal parasites of cattle (Shoop et al., 1996; Gogolewski et al.,
1997a, 1997b; Holste et al., 1997, 1998; Pitt et al., 1997;
Williams et al., 1997; Yazwinski et al., 1997; Campbell
et al., 2001; Rehbein et al., 2005). Activity of eprinomectin
in a 0.5% formulation administered topically at 1 mL/10 kg
bodyweight (0.5 mg eprinomectin/kg) against Sarcoptes
mite infestations was reported in several controlled studies
and under field conditions (Barth et al., 1997; Thompson
et al., 1997; Watson and Forbes, 2000; Rehbein et al.,
2003a).
In order to extend the persistent activity of epri-
nomectin with regard to endoparasites, an injectable
formulation has been developed which releases the active
in concentrations to provide effective control of nema-
tode infections in cattle for up to 150 days (Soll et al.,
2013). In this extended-release injection (ERI) formula-
tion, eprinomectin is released from a matrix formed with
poly(d,l-lactide-co-glycolic)acid (PLGA). PLGA is known as
a safe and effective biodegradable material which has been
used as a drug delivery system for extended release appli-
cations of various pharmaceutical compounds, including
ivermectin (Lewis, 1990; Miller et al., 1999; Clark et al.,
2004; Winzenburg et al., 2004).
The objective of the studies reported here was to
evaluate the therapeutic efficacy of Eprinomectin ERI for-
mulation against infestations with S. scabiei var. bovis
(sarcoptic mange) on cattle.
2. Materials and methods
A total of three controlled studies were conducted
according to similar protocols, two in Germany and one in
Austria. The studies were designed and conducted to com-
ply with the regulatory requirements of both the FDA/CVM
and the European Medicines Agency/Committee for Medic-
inal Products for Veterinary Use, and according to relevant
guidelines for Good Clinical Practices (GCPs) and for estab-
lishing the efficacy of acaricides against mange mites on
ruminants (Vercruysse et al., 2006).
The studies were performed as blinded studies, i.e., all
personnel involved in collecting data were masked to the
treatment assignment of the animals.
2.1. Experimental animals
A total of 44 (28 male and 16 female) healthy, rumi-
nating Braunvieh (Brown Swiss) or Fleckvieh (Simmental)
cattle, weighing 149–248 kg prior to treatment (day-1), and
aged approximately five to seven months, were included in
three studies conducted in Germany (studies 1 and 2) and
in Austria (study 3). The animal descriptions and details are
presented in Table 1. Animals had not been treated previ-
ously with an avermectin or milbemycin product and were
free of Sarcoptes mite infestation (as determined by thor-
ough body inspection and/or examination of skin scrapings
prior to initial mite infestation).
In all studies, cattle were held indoors under con-
ventional conditions including ambient temperature and
lighting. They were individually housed, tethered and
stanchioned so as to prevent self-grooming and physical
contact between animals. The animals were maintained
on forage-based diets in each of the studies as per local
practice (hay combined with either corn cobs or corn
silage). Drinking water was supplied by automatic water-
ers.
Animals were handled and treated with due regard for
their welfare and in compliance with Merial Institutional
Animal Care and Use Committee (IACUC) approvals, as well
as according to applicable local regulations, and require-
ments of the local IACUC.
2.2. Infestations
In each study, the animals were infested experimentally
at the withers with the following numbers of S. scabiei var.
bovis mites: study 1, ∼7300 and ∼6400 mites applied on
study days −56 and −49, respectively; study 2, ∼6800 and
∼4200 mites applied on study days −56 and −50, respec-
tively; study 3, ∼1600 and ∼2800 mites applied on study
days −57 and −48, respectively. The Sarcoptes strain used
for experimental infestation of cattle in the German stud-
ies was isolated from a naturally-infested cow in Germany
and had been passaged continuously on cattle before being
used for infestation of the study animals. The Sarcoptes
mites used to infest the cattle in the Austrian study were
collected directly from a naturally-infested Braunvieh cow
purchased at a local livestock market in Austria shortly
before the commencement of the study in late autumn.
2.3. Experimental design
A randomized block design based on pre-treatment
bodyweight was used in each study with the individual
animal being the experimental unit. Six (study 1) or eight
replicates of two cattle each (studies 2 and 3) were formed
sequentially based on decreasing pre-treatment (day −1)
bodyweight. Within replicates, animals were allocated ran-
domly to treatment: one to the control (vehicle-treated)
group and one to the Eprinomectin ERI group. Six or eight
blocks of stanchions were formed. Assignments of repli-
cates to blocks and of animals within blocks to stanchion
were done at random.
Treatments, vehicle (formulation that consisted of
the excipients of the Eprinomectin ERI) or Eprinomectin
ERI (eprinomectin 5% in a PLGA-based formulation) at
1.0 mg eprinomectin/kg, were administered at 1 mL/50 kg
(1 mL/110 lb) bodyweight once (day 0) by subcutaneous
injection in front of the shoulder using commercial dispos-
able syringes and needles. All cattle were observed hourly
for four or five hours post-treatment and thereafter once
daily throughout the studies for health problems or adverse
drug events.
Animals were weighed prior to initial infestation (day
−56 for studies 1 and 2, day −58 for study 3), prior to treat-
ment (day −1) for allocation and dose calculation, and at
study end (day 56).
 M. Visser et al. / Veterinary Parasitology 192 (2013) 359–364 361

Table 1
Animal description and details.

Study Treatmenta /Animals per TREATMENT Breed Sex ∼Age (months) Pre-treatment bodyweight (kg)

1 Control, n = 6 Braunvieh Male 6.5 149–174

EpERI, n = 6 (Brown Swiss)

2 Control, n = 8 Fleckvieh Male 7 210–248

EpERI, n = 8 (Simmental)

3 Control, n = 8 Fleckvieh Female 5–7 150–221

EpERI, n = 8 (Simmental)
a
Control = ERI vehicle-treated; EpERI = Eprinomectin ERI.

2.4. Mite counts and mange lesion scores
Live mites were counted in scrapings collected from
the edges of active lesions or, if lesions regressed dur-
ing the study, from the area where active lesions had
been present at study commencement. Scrapings were
made using a sharp spoon from an area approximately
3 cm × 3 cm. Six sites were scraped on each animal at each
occasion. Scrapings were taken on day −1 prior to treat-
ment, on day 7, and at approximately 7-day intervals
thereafter until study termination on day 56. For counting
the mites, warm water with a small amount of detergent
was added to each scraping sample, and the sample was
shaken for 10 min. Then the mites were washed out of the
samples onto black filter paper by filtering the material
through a Buchner funnel apparatus equipped with a vac-
uum pump. The black filter paper discs were thoroughly
examined for living mites (assessed based on motility)
using a stereoscopic microscope (Barth and Visser, 1985).
The live mites present in each scraping were counted up
to a maximum of 100 in studies 1 and 2; counts above
100 were recorded as “>100”. In study 3, all live mites
present in a scraping were counted. Total mite counts at
each time point were calculated from summing the counts
from each scraping site for each animal. The site of each
scraping was recorded on a silhouette in addition to the
assessment (score) of the mange lesions at each examina-
tion.

Table 2
Evolution of Sarcoptes scabiei var. bovis mite counts in experimentally infested cattle which were either vehicle-treated (control) or treated with Epri-
nomectin ERI on Study Day 0 and followed-up for eight weeks after treatment.

Study Study day Control (ERI vehicle) Eprinomectin ERI Efficacyd Probabilitye
a b,c
Prev GM (range) Prev GM (range)

Live Sarcoptes scabiei var. bovis mites

1 −1 6/6 >276.2 (68 –>600) 6/6 >235.5 (110–508) – nsf
7 6/6 >303.9 (28 –>600) 2/6 0.6 (0–5) >99% <0.05
14 6/6 >385.1 (71–>600) 1/6 0.1 (0–1) >99% <0.05
21 6/6 >336.9 (37–>600) 0/6 0 100% <0.05
28 6/6 >341.3 (23–>600) 0/6 0 100% <0.05
36 6/6 >323.7 (22–>600) 0/6 0 100% <0.05
42 6/6 >254.9 (5–>600) 0/6 0 100% <0.05
49 6/6 >255.1 (5–>600) 0/6 0 100% <0.05
56 6/6 >204.8 (2–>600) 0/6 0 100% <0.05

2 −1 8/8 >311.0 (71–>600) 8/8 >281.4 (73–>600) – ns

7 8/8 >398.0 (75–>600) 0/8 0 100% <0.05
14 8/8 >421.3 (136–>600) 0/8 0 100% <0.05
21 8/8 >487.3 (158–>600) 0/8 0 100% <0.05
28 8/8 >519.1 (>402–>600) 0/8 0 100% <0.05
35 8/8 >547.4 (>368–>600) 0/8 0 100% <0.05
42 8/8 >563.7 (>483–>600) 0/8 0 100% <0.05
49 8/8 >545.2 (>401–>600) 0/8 0 100% <0.05
56 8/8 >562.8 (>436–>600) 0/8 0 100% <0.05

3 −1 8/8 64.6 (15–1232) 8/8 69.9 (17–425) – ns

7 8/8 120.3 (35–1620) 5/8 2.9 (0–240) 97.6% <0.05
14 8/8 124.3 (45–545) 1/8 0.6 (0–39) >99% <0.05
21 8/8 177.7 (15–11331) 1/8 0.2 (0–4) >99% <0.05
28 8/8 151.6 (10–2488) 0/8 0 100% <0.05
35 8/8 218.0 (11–2275) 0/8 0 100% <0.05
42 8/8 187.6 (6–1863) 0/8 0 100% <0.05
49 8/8 254.6 (2–4804) 0/8 0 100% <0.05
56 8/8 501.5 (5–1508) 0/8 0 100% <0.05
a
Prevalence: number of cattle infested/Number of cattle in group.
b
Geometric mean counts (based on transformation to the natural logarithm of [count + 1]).
c
Mean preceded by “>” had at least one animal with a site with more than 100 mites.
d
Efficacy = 100 × (GM control [ERI vehicle] − GM Eprinomectin ERI/GM control [ERI vehicle]).
e
Probability from Wilcoxon rank sum test.
f
Not significant at ˛ = 0.05.
362 M. Visser et al. / Veterinary Parasitology 192 (2013) 359–364

Table 3
Evolution of mange lesion scores in experimentally infested cattle which were either vehicle-treated (control) or treated with Eprinomectin ERI on Study
Day 0 and followed-up for eight weeks after treatment.

Study Study day Mange lesion scorea (number of animals) Probabilityb

Control (ERI vehicle) Eprinomectin ERI

(n = 6 or 8) (n = 6 or 8)

1 −1 ++ (6) ++ (6) nsc

7 ++ (6) ++ (6) ns
14 ++ (4)/+++ (2) (+) (5)/++ (1) <0.05
21 ++ (3)/+++ (3) (+) (6) <0.05
28 ++ (2)/+++ (4) (+) (6) <0.05
36 ++ (2)/+++ (4) (+) (6) <0.05
42 ++ (2)/+++ (4) (+) (6) <0.05
49 ++ (2)/+++ (4) (+) (6) <0.05
56 ++ (1)/+++ (5) (+) (6) <0.05

2 −1 ++ (8) ++ (8) ns
7 ++ (7)/+++ (1) ++ (8) ns
14 ++ (6)/+++ (2) (+) (1)/++ (7) ns
21 ++ (6)/+++ (2) (+) (8) <0.05
28 ++ (6)/+++ (2) (+) (8) <0.05
35 ++ (4)/+++ (4) (+) (8) <0.05
42 ++ (5)/+++ (3) (+) (8) <0.05
49 ++ (5)/+++ (3) 0 (2)/(+) (6) <0.05
56 ++ (1)/+++ (7) 0 (7)/(+) (1) <0.05

3 −1 ++ (8) ++ (8) ns
7 ++ (8) ++ (8) ns
14 ++ (8) + (3)/++ (5) ns
21 ++ (8) 0 (2)/(+) (4)/+ (2) <0.05
28 ++ (8) 0 (5)/(+) (1)/+ (2) <0.05
35 ++ (8) 0 (6)/(+) (2) <0.05
42 + (1)/++ (7) 0 (6)/(+) (2) <0.05
49 + (1)/++ (7) 0 (6)/(+) (2) <0.05
56 + (1)/++ (7) 0 (7)/(+) (1) <0.05
a
0 = healthy skin. (+) = healing lesion, crusts lifted and detached easily but hair growth not complete. + = active lesion, extent less than the palm of the
hand. ++ = active lesion, extent more than the palm of the hand. +++ = active lesion, extent more than half of the body of the animal.
b
Probability from Wilcoxon rank sum test comparing Eprinomectin ERI to control (ERI vehicle).
c
Not significant at ˛ = 0.05.

When skin scrapings were taken, the mange lesions
were assessed and scored as follows (Rehbein et al., 2003b):
0 = healthy skin; (+) = healing lesion, crusts detached
easily but hair growth not complete; + = active lesion,
extent of less than the palm of the hand; ++ = active lesion,
extent of more than the palm of the hand; +++ = active
lesion, extent of more than half of the body of the animal.
2.5. Statistical methods
The number of living mites at each time point was
transformed to the natural logarithm of (count + 1) for
calculation of geometric means. Treatment groups were
compared using Wilcoxon rank sum test at each time point.
A two-sided test was used at the 0.05 significance level.
Efficacy was calculated as 100[(C − T)/C], where C is the geo-
metric mean for the control (ERI vehicle-treated) group and
T is the geometric mean for the Eprinomectin ERI-treated
group. Bodyweight and weight gain were analyzed using a
mixed model analysis of variance including treatment as a
fixed effect and replicate as a random effect. Lesion scores
were analyzed using Wilcoxon rank sum test at each time
point.
3. Results
Following infestation, all 44 experimental animals
developed active mange lesions spreading from the
withers mainly over the shoulder to the chest, the flanks
and the back as confirmed by pre-treatment examination.
All 22 control (vehicle-treated) animals remained infested
with S. scabiei var. bovis, and active lesions were recorded
on all of them, throughout the duration of the studies
(Tables 2 and 3). Mange lesions covering more than half
of the body surface were observed in 5 and 7 control
animals in studies 1 and 2, respectively. Therefore, those
animals received salvage treatments (topical organophos-
phate spray) for welfare reasons to prevent further spread
of mange. After end of the studies, all control animals were
appropriately treated with an authorized acaricidal prod-
uct.
Live mite counts of the Eprinomectin ERI-treated cat-
tle were significantly (p < 0.05) lower than the control
(vehicle-treated) cattle counts at all post-treatment study
days. Reductions of mite counts were 100% from days 21,
7, and 28 for studies 1, 2, and 3, respectively. Mite counts
are summarized in Table 2.
Mange lesion scores of Eprinomectin ERI-treated cat-
tle at study days 14–56 (study 1), and days 21–56 (studies
2 and 3), were significantly (p < 0.05) lower than the con-
trol (vehicle-treated) cattle scores. No “active” lesions were
observed on any treated animal from five weeks after treat-
ment onwards to the end of the studies whereas all control
(vehicle-treated) cattle had active lesions throughout the
study (Table 3).
 M. Visser et al. / Veterinary Parasitology 192 (2013) 359–364 363

Summary of bodyweight and weight gain data in experimentally infested cattle which were either vehicle-treated (control) or treated with Eprinomectin ERI on Study Day 0 and followed-up for eight weeks
Bodyweight and weight gain data are summarized in

Mean weight gain (kg)

Table 4. There was no difference in the weight gain of
the animals of the two treatment groups during the pre-

day −1 – day 56
treatment period (day −58/−56 to day −1). During the
eight week observation period following day 0 treatment,

Probability
cattle treated with Eprinomectin ERI gained more weight

<0.05

<0.05
than the ERI vehicle-treated controls in all three studies

19.7
44.8

25.6
39.8

58.7
62.8
ns
(24.1 kg, 14.2 kg and 4.1 kg, respectively). The difference in
final weight and bodyweight gain was significantly differ-
ent from controls (p < 0.05) in two studies, but not in the
third.

Mean weight gain (kg)

pre-infestationc – Day
With the exception of signs associated with mange
infestation, all animals were reported as normal. Hourly

−1 Probability
observations for four or five hours post-treatment, revealed
no changes from pre-treatment health status, indicating
that Eprinomectin ERI and ERI vehicle treatments were well

36.3
34.3

35.8
39.6

52.2
54.2
accepted. There were no drug-related health problems or

ns

ns

ns
adverse drug events observed at any time during the stud-
ies.

4. Discussion

Mean day 56 bodyweight

In these studies, a single injection of Eprinomectin ERI
effectively eliminated Sarcoptes mites from cattle, and the

(kg) Probability
rapid reduction of mite counts was correlated to the clini-
cal improvement in the treated animals. This efficacy of the
Eprinomectin ERI against S. scabiei var. bovis was similar to

181.2

243.5
244.7
250.2
265.0
204.0
<0.05

<0.05
that previously observed after pour-on application of the

Probability values from mixed model analysis of variance comparing Eprinomectin ERI to control (ERI vehicle).
ns
0.5% topical formulation of eprinomectin (Barth et al., 1997;
Thompson et al., 1997; Watson and Forbes, 2000; Rehbein
et al., 2003a). These results also are consistent with those
of other studies that evaluated the acaricidal activity of the
Mean day −1 bodyweight

conventional 1% ivermectin and abamectin injectable for-

mulations (Barth and Sutherland, 1980, 1983; Lavigne and
Smith, 1983; Danĕk et al., 1985; Soll et al., 1987; Heinze-
(kg) Probability

Mutz et al., 1993; Rehbein et al., 2003b).

At study completion eight weeks following treatment,
there was still some evidence of skin damage at some
161.5
159.2

224.6
225.2

184.8
181.9

sites where active mange lesions were present before Epri-

ns

ns

ns

nomectin ERI treatment. This observation is most likely

Arithmetic means for study 1; least squares means for studies 2 and 3.

related to the limited ability of the study animals to groom.

In all of the treated animals, skin lesions were scored “heal-
ing” from five weeks following treatment.
Meanb pre-infestationc

Eprinomectin ERI treatment of cattle with sarcoptic

Control = ERI vehicle-treated; EpERI = Eprinomectin ERI.
bodyweight (kg)

mange resulted in an improved weight gain compared to

Day −56 for studies 1 and 2 or day −58 for study 3.

the control animals, and this finding re-emphasizes the

Probabilityd

negative impact of bovine sarcoptic mange on growth per-

formance. This observation is in agreement with numerous
125.2
124.8

188.8
185.6

132.6
127.7
nse

studies where significant improvements in weight gain

ns

ns

have been reported for cattle which were infested with Sar-
coptes mites and successfully treated with eprinomectin
pour-on (Barth et al., 1997; Rehbein et al., 2003a), iver-
Control, n = 6

Control, n = 8

Control, n = 8

Not significant at ˛ = 0.05.

mectin injection or pour-on (Danĕk et al., 1985; Löwenstein

Treatmenta

EpERI, n = 6

EpERI, n = 8

EpERI, n = 8

and Kutzer, 1996; Rehbein et al., 2003b), or abamectin

injection (Heinze-Mutz et al., 1993). The higher weight gain
responses observed with Eprinomectin ERI-treated cattle
after treatment.

in studies 1 and 2 compared to study 3 versus the respec-

tive controls are clearly related to the different levels of
infestation as demonstrated by the results of examinations
Study
Table 4

of the vehicle-treated controls. Controls in studies 1 and 2

1

exhibited more severe infestations over the study period

364 M. Visser et al. / Veterinary Parasitology 192 (2013) 359–364
than controls in study 3 based on average mite counts and
size of active mange lesions.
However, therapeutic intervention in sarcoptic mange
infested cattle is not only indicated for the clear impact on
productivity. Sarcoptic mange was demonstrated to have
animal welfare implications, and treatment resulted in
reduced levels of behaviors such as rubbing and scratching
and longer time spent lying down (Rehbein et al., 2003a).
In addition, there are reports of pruritic dermatoses in
humans who became infested with cattle sarcoptic mites
when handling infested animals (e.g., Mumcuoglu and
Rufli, 1979; Haarløv and Møller-Madsen, 1983).
In conclusion, the results of the studies confirmed the
excellent efficacy of eprinomectin in an extended-release
formulation for treatment of bovine sarcoptic mange at
the dose that was selected to provide effective control of
nematode infections in cattle for up to 150 days.
Conflict of interest statement
The work reported herein was funded by Merial Limited,
GA, USA.
All authors are current employees (MV, SY, SR) or
were contractors (ML) of Merial and assisted with the
study design, conduct, data analysis and review of the
manuscript.
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