Comparative efficacy and safety of topical permethrin, topical ivermectin, and oral ivermectin in patients of uncomplicated scabies

Abstract

Background:
Ivermectin has opened a new era in the management of scabies as orally effective drug. However, topical route has been little explored for ivermectin.

Aims:
To compare the efficacy and safety of topical permethrin, oral ivermectin, and topical ivermectin in the treatment of uncomplicated scabies.

Methods:
This was an open-label, randomized, comparative, parallel clinical trial conducted in 315 patients, randomly allocated to 3 groups. First group received permethrin 5% cream as single application, second group received tablet ivermectin 200 mcg/kg as single dose, and third group received ivermectin 1% lotion as single application. All the patients received anti-histaminic for pruritus. The patients were followed up at intervals of 1, 2, 3, and 4 weeks. If there were no signs of cure, the same intervention was repeated at each follow up. Primary efficacy variable was clinical cure of lesions. Statistical analysis was done by chi square test and one way ANOVA test using SPSS version 12.

Results:
At the end of first week, cure rate was 74.8% in permethrin group, 30% in oral ivermectin group, and 69.3% in topical ivermectin group (P < 0.05). At the end of second week, cure rate was 99% in permethrin group, 63% in oral ivermectin group, and 100% in topical ivermectin group (P < 0.05). At the end of third week, 100% cure rate was observed in permethrin and topical ivermectin group while 99% in oral ivermectin group (P = 0.367). No serious adverse events were observed.

Conclusions:
Permethrin and topical ivermectin were equally effective against scabies while oral ivermectin was significantly less effective up to 2 weeks. Topical ivermectin can be used as an alternative to permethrin.

Full text

605Indian Journal of Dermatology, Venereology, and Leprology | September-October 2012 | Vol 78 | Issue 5
Comparative efcacy and safety of topical
permethrin, topical ivermectin, and oral ivermectin in
patients of uncomplicated scabies
Sunita B. Chhaiya, Varsha J. Patel
1
, Jayendra N. Dave
2
, Dimple S. Mehta,
Hiral A. Shah
2
Original
Article
ABSTRACT
Background: Ivermectin has opened a new era in the management of scabies as orally
effective drug. However, topical route has been little explored for ivermectin. Aims: To
compare the efcacy and safety of topical permethrin, oral ivermectin, and topical ivermectin
in the treatment of uncomplicated scabies. Methods: This was an open-label, randomized,
comparative, parallel clinical trial conducted in 315 patients, randomly allocated to 3 groups.
First group received permethrin 5% cream as single application, second group received
tablet ivermectin 200 mcg/kg as single dose, and third group received ivermectin 1% lotion
as single application. All the patients received anti-histaminic for pruritus. The patients were
followed up at intervals of 1, 2, 3, and 4 weeks. If there were no signs of cure, the same
intervention was repeated at each follow up. Primary efcacy variable was clinical cure of
lesions. Statistical analysis was done by chi square test and one way ANOVA test using
SPSS version 12. Results: At the end of rst week, cure rate was 74.8% in permethrin group,
30% in oral ivermectin group, and 69.3% in topical ivermectin group (P < 0.05). At the end
of second week, cure rate was 99% in permethrin group, 63% in oral ivermectin group, and
100% in topical ivermectin group (P < 0.05). At the end of third week, 100% cure rate was
observed in permethrin and topical ivermectin group while 99% in oral ivermectin group (P
= 0.367). No serious adverse events were observed. Conclusions: Permethrin and topical
ivermectin were equally effective against scabies while oral ivermectin was signicantly less
effective up to 2 weeks. Topical ivermectin can be used as an alternative to permethrin.
Key words: Ivermectin, permethrin, scabies, topical
Departments of Pharmacology
and 2Dermatology,
C. U. Shah Medical College,
Surendranagar, Gujarat,
1NHL Municipal Medical
College, Ahmedabad, Gujarat,
India
Address for correspondence:
Dr. Sunita B. Chhaiya,
Department of Pharmacology,
C. U. Shah Medical
College, Dudhrej Road,
Surendranagar, Gujarat,
India.
E-mail:
s_chhaiya@rediffmail.com
How to cite this article: Chhaiya SB, Patel VJ, Dave JN, Mehta DS, Shah HA. Comparative efcacy and safety of topical permethrin,
topical ivermectin, and oral ivermectin in patients of uncomplicated scabies. Indian J Dermatol Venereol Leprol 2012;78:605-10.
Received: October, 2011. Accepted: June, 2012. Source of Support: Gift of ivermectin powder, lotion base, permethrin cream 5% and
tablet ivermectin from Shalaks Pharmaceutical Ltd. New Delhi. Conict of Interest: None declared.
INTRODUCTION
Scabies is a common parasitic infection caused by the
mite Sarcoptes scabiei var. hominis. It is a major global
health problem in many indigenous and third world
communities.[1] It has been estimated that 300 million
people suffer from scabies infestation at any one
time. Scabies is an important disease of children,
but it occurs in both sexes at all ages, in all ethnic
groups and in all socio-economic levels.[2] Different
therapies for scabies consist of topical anti-scabietics
such as benzyl benzoate, crotamiton, lindane, and
permethrin. At present, permethrin 5% has become
the anti-scabietic of choice in United States because
of report of resistance to and central nervous system
toxicity to lindane.[3] Ivermectin is an anti-parasitic
agent, effective against a variety of endoparasites and
ectoparasites.[4] Initial reports have highlighted the
utility of oral ivermectin in the treatment of scabies.
[5- 13]
Topical ivermectin has also been shown to be effective
in some studies.[14-16] However, these studies were non-
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Chhaiya, et al. Topical permethrin, topical ivermectin and oral ivermectin in uncomplicated scabies
Indian Journal of Dermatology, Venereology, and Leprology | September-October 2012 | Vol 78 | Issue 5606
comparative and were conducted with small number
of patients. Hence, this randomized clinical study was
planned and conducted to generate more data regarding
efficacy and safety of topical ivermectin in treatment
of scabies and to compare with oral ivermectin and
currently available first line drug permethrin.
METHODS
This was an open-label, randomized, comparative,
parallel group clinical trial. The study was approved by
the institutional ethics committee and was performed
as per the ICH-GCP guidelines and GCP guidelines by
government of India. From June 2007 to January 2009,
the patients willing to participate were enrolled using
following inclusion and exclusion criteria.
Inclusion criteria
1. Patients of either sex aged 5 to 80 years with
clinically-diagnosed scabies, 2. Presence of typical
scabietic lesions like papules, nodules, or vesicles
at classical sites, 3. Presence of classical burrows
on clinical examination, 4. Nocturnal pruritus,
5. History of involvement of family member or similar
symptoms in contacts, 6. Microscopically-diagnosed
scabies (demonstration of egg, larvae, mite, or fecal
material), 7. Patients whose microscopic examination
was negative, their inclusion in study was based on
clinical criteria, for that patient had to satisfy at least
3 out of 4 inclusion criteria (inclusion criteria no. 2
to 5), 8. Patients who were willing to participate and
give written informed consent.
Exclusion criteria
1. Patient treated with any topical scabicidal therapy in
the month before entry, 2. Patients taking any topical
or systemic antibiotic therapy in the week before entry
into the study, 3. Immunologically-compromised
patients, 4. Having scabies with atypical presentation
like crusted scabies or scabies incognito, 5. Patients
with secondary bacterial infection, 6. History of allergy
to any of the study drugs, 7. Blood pressure < 100/60
mm Hg, 8. Pregnancy in women and lactating mothers.
Severity of lesions was clinically graded on a scale of
0 to 3. Grade 0 - free of lesions (no lesions), Grade 1 -
10 or fewer lesions (mild), Grade 2 - 11 to 49 lesions
(moderate), Grade 3 - 50 or more lesions (severe).
Itching was graded on a scale of 0 to 3 on basis of
severity. Grade 0 - no itching, Grade 1 - mild itching,
Grade 2 - moderate itching, Grade 3 - severe / intense
itching.
Sample size
Sample size was calculated by using sample size
calculator (Raosoft, 2004). Considering alpha error at
5%, confidence level at 90%, and sample size of 267
patients was obtained. Considering dropout rate 10%,
sample size of 294 was finalized.
Randomization
The 315 enrolled participants were allocated to any 1 of
the 3 treatment groups according to random allocation
number generated through computer by using complete
randomized design for 3 treatment groups [Figure 1].
Interventions
Permethrin 5% Cream
Permethrin 5% cream was supplied by Shalaks
Pharmaceutical Ltd., New Delhi. The patients included
in this group were given permethrin 5% cream along
with printed information sheet in the local vernacular
language. They were asked to apply the cream to whole
body covering neck to toe. They were explained that
the cream must remain in contact with the skin for
at least 8 hours. They were advised to take bath with
warm water not earlier than 8 hours after application.
Tablet ivermectin
Tablet ivermectin was supplied by Shalaks
Pharmaceutical Ltd., New Delhi. The patients
included in this group were given tablet ivermectin
orally in the dose of 200 mcg/kg as a single dose to
be self-administered along with printed information
sheet in the local vernacular language.
Ivermectin lotion 1%
Ivermectin powder and lotion base were supplied by
Shalaks Pharmaceutical Ltd., New Delhi. Ivermectin
1% lotion was prepared by mixing 1 gram ivermectin
powder with 100 ml lotion base (contains propylene
glycol). It was prepared according to the requirement.
Proper aseptic measures were observed during the
preparation. The patients included in this group
were given ivermectin 1% lotion along with printed
information sheet in the local vernacular language.
The information sheet contained details regarding
application of drug and other instructions. They were
asked to apply the lotion to all the affected sites. They
were explained that the lotion must remain in contact
with the skin for at least 8 hours. They were advised
to take bath with warm water not earlier than 8 hours
after application.
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Chhaiya, et al. Topical permethrin, topical ivermectin and oral ivermectin in uncomplicated scabies
607Indian Journal of Dermatology, Venereology, and Leprology | September-October 2012 | Vol 78 | Issue 5
Antihistaminic
All patients received orally hydroxyzine 10 mg or 25
mg twice-daily for symptomatic treatment of pruritus.
Assessment of patients
Patients were followed up at the end of first, second,
third, and fourth week to assess compliance and to
examine the patient to evaluate efficacy and safety.
Primary end point was clinical cure of scabietic
lesions, and Secondary end point was complete relief
of pruritus. At each of the 4 visits, examination of the
entire body surface was performed. All remaining
suspected scabies lesions were examined and
compared with baseline clinical grading score and
itching grading score. The patients were asked for any
adverse event occurring during previous week. The
cured participants were prescribed anti-histaminic for
further 1 week if itching grade was severe or moderate.
If the patients had mild itching, no anti-histaminic
was prescribed. The participants who were not cured
were prescribed repeat intervention along with anti-
histaminic. All the participants were again called for
follow-up visit after 1 week. The participants who
were not cured at the end of third week were switched
over to standard treatment with 5% permethrin.
Statistical analysis
It was done by using SPSS version 12.0. Differences in
proportions were compared with the Chi-square test.
Statistical analysis of efficacy was done by Chi-square
test and one way ANOVA test. Post hoc test was used
to identify significant difference between the groups
for which LSD (Least Significant Differences) test was
used. P values < 0.05 were considered significant.
RESULTS
Total 315 patients were enrolled in the study and
randomly allocated to 3 treatment groups, each
group having 105 patients. There was no significant
difference between the 3 study groups at baseline in
demographic and clinical characteristics [Table 1]. At
each follow-up visit, patients were assessed clinically
as only 22.5% patients were positive on microscopic
examination at initial visit.
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Chhaiya, et al. Topical permethrin, topical ivermectin and oral ivermectin in uncomplicated scabies
Indian Journal of Dermatology, Venereology, and Leprology | September-October 2012 | Vol 78 | Issue 5608
Clinical cure rate at different visits shows [Table 2]
that there is significant difference between tablet
ivermectin group and the other 2 groups up to 2
weeks (P < 0.05). At the end of third week, there was
no statistically significant difference between the 3
groups (P = 0.367). [Figure 2]
Considering pruritus as main symptom, the anti-scabies
medication, which alleviates it, has greater acceptance
in clinical practice. Improvement in itching grade at
different visits [Table 3 and Figure 3], which was the
secondary end point for the study, shows that topical
ivermectin and permethrin cause rapid improvement
in itching compared to tablet ivermectin (P < 0.05).
At the end of fourth week, 2 patients in permethrin
group, 5 patients in oral ivermectin group, and 1
patient in topical ivermectin group failed to follow-up.
They were cured clinically at the end of third week.
Safety
No major adverse events were observed in any
of the 3 groups. One patient in permethrin group
developed burning sensation after applying drug,
but it was relieved within few minutes. 2 patients in
tablet ivermectin group developed mild headache and
increase in pruritus, respectively, which subsided
without any medication.
DISCUSSION
This randomized trial was planned to evaluate the
efficacy and safety of topical ivermectin and compare
it with oral ivermectin and topical permethrin.
Topical ivermectin as 1% lotion was as effective as 5%
permethrin and was significantly more effective than
oral ivermectin.
In the present study, clinical cure rate of oral ivermectin
was 30% at the end of first week. Our finding differs
from other studies as clinical cure rate observed at
the end of first week was 79.3%, 50%, and 55.56%,
respectively.[6,8,13]
Clinical cure rate for oral ivermectin with 2 doses was
63% at the end of second week. The cure rate was
substantially lower than that reported by other studies
using single dose of oral ivermectin. The cure rate
Table 3: Improvement of itching grade at each follow up visit
Permethrin 5% - %n = 99 Tab. Ivermectin - %n = 100 Ivermectin 1% - %n = 101
Baseline 1st W 2ndW 3rd W 4th W Baseline 1st W 2nd W 3rd W 4th W Baseline 1st W 2nd W 3rd W 4th W
Severe 91.9 6.1 0 0 0 96 35 1 0 0 93.1 13.8 0 0 0
Moderate 8.1 70.7 9.1 0 0 4 62 52 2 0 6.9 53.5 11.8 0 0
Mild 0 22.2 67.7 9.1 0 0 3 44 50 0 0 32.7 53.5 5 0
No lesions 0 1 23.2 90.9 98 0 0 3 48 95 0 0 34.7 95 99
1stW:Firstweek,2ndW:Secondweek,3rdW:Thirdweek,4thW:Fourthweek
Table 1: Baseline characteristics of three treatment groups
Permethrin 5% n = 105 Tab. Ivermectin n = 105 Ivermectin 1% n = 105 P value (*)
Age(mean ±SD)
Gender(Male/Female)
FamilyHistory (%)
Lab.Diagnosis (%)
Nocturnalpruritus (%)
Severityof disease:
Severe/moderate /mild/no lesions(%)
23.40± 13.55
58/47
89.5
19
100
13.1 /36.4 /46.5 /4
21.97± 13.26
58/47
87.6
24.8
100
19/39 /38/4
22.52± 12.69
59/46
85.7
23.8
100
16.8 /40.6 /38.6 /4
0.843
0.987
0.704
0.569
0.47
0.881
*:ByusingChisquaretest
Table 2: Improvement of clinical grade at each follow up visit
Permethrin 5% - %n = 99 Tab. Ivermectin - %n = 100 Ivermectin 1% - %n = 101
Baseline 1st W 2ndW 3rd W 4th W Baseline 1st W 2nd W 3rd W 4th W Baseline 1st W 2nd W 3rd W 4th W
Severe 13.1 0 0 0 0 19 0 0 0 0 16.8 0 0 0 0
Moderate 36.4 5.1 0 0 0 39 31 0 0 0 40.6 11.9 0 0 0
Mild 46.5 20.1 1 0 0 38 39 37 1 0 38.6 18.8 0 0 0
No lesions 4.0 74.8 99 100 100 4 30 63 99 99 4.0 69.3 100 100 100
1stW:Firstweek,2ndW:Secondweek,3rdW:Thirdweek,4thW:Fourthweek
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Chhaiya, et al. Topical permethrin, topical ivermectin and oral ivermectin in uncomplicated scabies
609Indian Journal of Dermatology, Venereology, and Leprology | September-October 2012 | Vol 78 | Issue 5
reported after single dose at the end of 2 weeks were
74%, 70%, and 79%, respectively.[7,8,11] Bachewar et al,
reported 100% cure rate with 2 doses of oral ivermectin
at the end of 2 weeks.[13] While Fatimata et al, reported
much lower cure rate of 24.6% at the end of second
week with single dose.[12] At the end of 3 weeks, 3
doses of oral ivermectin achieved 99% cure rate. One
study reported 56% cure rate with single dose at third
week.[10] Several studies reported 95% cure rate with
oral ivermectin at the end of 4 weeks with 2 doses of
oral ivermectin.[7,8,11] Thus, repeating treatment every
week achieves higher cure rate with oral ivermectin.
However, clinical cure with topical ivermectin is
seen earlier as in case of topical permethrin. Because
ivermectin has not been proven to be ovicidal, a single
oral dose of 200 mcg/kg body weight may be inadequate
to eradicate the different stages of the parasites, and a
higher dose or a second dose may be required within 1
or 2 weeks for 100% cure rate.[8]
As far as the relief from pruritus is concerned, at 3
weeks follow-up, 48% patients were free of pruritus
in oral ivermectin group compared to 90.9% and
95% in permethrin and topical ivermectin group,
respectively. It suggests that topical ivermectin and
permethrin rapidly cured disease and hence led to
rapid improvement in pruritus compared to oral
ivermectin. A previous study also showed that oral
ivermectin was less effective in relieving pruritus
as compared to permethrin.[13] A drug with a faster
effect in relieving pruritus is much more acceptable
to patients. Moreover, such drug will also reduce the
requirement of anti-histaminic.
While oral ivermectin was found to be significantly
less effective than the 2 topical treatments, there was
no difference in effectiveness of topical permethrin
and topical ivermectin. This difference sustained
up to 2 weeks. The faster cure with permethrin and
topical ivermectin would reduce the number of follow
up visits required, thus improving compliance and
reducing the cost.
In all the 3 treatment groups, no severe/serious adverse
events were observed. Only 3 patients had mild adverse
events- mild burning sensation in permethrin group,
headache, and increase in pruritus in oral ivermectin
group. All these adverse events subsided without
any medication. No adverse events were observed in
topical ivermectin group.
A few small studies have reported efficacy of topical
ivermectin in scabies. In a study of 50 patients, all the
patients were cured clinically and parasitologically
within 48 hours after a single application. As
50% of scabies patients had persistent itching,
another application was given after 5 days to stop
itching.
[14] Yerham et al, reported a study of 10
patients with uncomplicated scabies, in which
marked improvement was seen in the condition of
the patients within 2 or 3 days of the first treatment,
and clinical cure occurred after 2 or 3 days of second
treatment with topical 1.8% ivermectin cream.[15]
In a study consisting of 12 adults and 20 children
treated with 1% ivermectin in a solution of propylene
glycol applied topically to the affected skin, Victoria
et al, reported that all the patients were cured
with the 2 applications at weekly interval.[16] Our
findings confirm these reports as single application
of ivermectin achieved 69.3% cure rate and with
second application, 100% cure rate was observed.
Figure 2: Clinical cure rate at different visits.* shows P < 0.05 for
tab. ivermectin compared to permethrin cream and ivermectin
lotion at the end of rst and second week using ANOVA followed
by post hoc test (LSD)
Figure 3: Cure rate for itching at different visits - * shows P < 0.05
for tab. ivermectin compared to permethrin cream and ivermectin
lotion at the end of rst and second week using Chi-square test
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Chhaiya, et al. Topical permethrin, topical ivermectin and oral ivermectin in uncomplicated scabies
Indian Journal of Dermatology, Venereology, and Leprology | September-October 2012 | Vol 78 | Issue 5610
This comparative randomized study shows that
compared to oral ivermectin, topical ivermectin
produces higher cure rate.
LIMITATIONS
The study was open-labeled. However, blinding was
not easy because the formulations were different that
is cream, lotion, and tablet. Possible variation, if any,
due to different formulations- lotion and cream, cannot
be ruled out. Still the study does show superiority of
topical over oral ivermectin in uncomplicated scabies.
CONCLUSION
To conclude, the present study shows that the ivermectin
1% lotion is as effective as permethrin 5% cream and is
definitely more effective compared to oral ivermectin
in uncomplicated scabies. Topical ivermectin is also as
safe as oral ivermectin and topical permethrin.
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