R e s e a r c h A r ticle

Comparison of safety, efficacy, and cost effectiveness of benzyl

benzoate, permethrin, and ivermectin in patients of scabies
N a r e nd r a P . B a c h e w a r , V ij a y R. T h a w a ni1, Smi t a N . M a li1, K und a J . G h a r pu r e 1, V a is h a li P . S hing a de 1,
Ganesh N . D akhale2

JMF’s A CPM Med. College,
D hule; 1 G overnment Medical
College, N agpur; 2Indira G andhi
G overnment Medical College,
N agpur, India
Received: 16.10.2008
Revised: 25.11.2008
Accepted: 27.12.2008
D O I: 10.4103/0253-7613.48882
Correspondence to:
Vijay Thawani
E-mail:
vijaythawani@rediffmail.com
A B STR A CT
O bjective: To compare three treatment modalities in scabies for safety, efficacy, and
economy in a local population of N agpur.
Materials and Methods: This was a prospective, randomized, comparative clinical trial
conducted in 103 participants, randomly allocated to three groups. First group received
benzyl benzoate (BB) 25% lotion, second group received permethrin 5% cream, whereas
third group received tablet ivermectin 200 µg/kg as a single dose. The participants were
recalled after one week for follow-up evaluation. If there were no signs of cure, the same
intervention was repeated. The participants were followed up for two weeks for cure rate,
adverse drug reaction (A DR) monitoring, and postintervention observation. The follow-up
was stopped after two weeks.
Statistics: Fischer’s exact test using Graph pad Instat v 3.05.
Results: Ivermectin showed 100% cure rate after two weeks of treatment. Permethrin
decreased pruritus by 76% at the end of one week and had significantly better cure rate
than ivermectin. At the end of two weeks treatment, this finding was reversed, that is, cure
rate in ivermectin group was 100%. For cost-effectiveness analysis, treatment regimens
were formulated hypothetically for comparison from Markov population tree for decision
analysis. It was found that BB and ivermectin each consecutively for two weeks were
most cost effective regimens giving complete cure in four weeks, while ivermectin was
the fastest regimen giving the same results in two weeks.
Conclusion: Benzyl benzoate as first line intervention and ivermectin in the remaining
gave best cost-effective results in the study patients of scabies.

KEY W O RDS: Efficacy, economic analysis, scabies, treatment

Introduction affected by scabies, masses have poor affordability for the

The annual incidence of scabies being three million, the
disease burden on the developing countries justifies this
study[1,2] in India. Scabies is of greater importance due to its
affinity for economically marginalized and immunocompromised
hosts.[3] Sarcoptes scabie gains its importance by making the
host morbid by its lesions, immense pruritus, high infectivity,
frequent relapses, persistence of symptoms for many days even
after eradication, and resistance to the routine treatment. [4]
Treatment of scabies has changed from Celsus to modern
medicine, from sulfur to permethrin and ivermectin.[5] Current
treatment of scabies comprises of topical antiscabetics, applied
all over the body for a specified contact period.[1] Research
has been attempted to find the best antiscabetic focusing on
efficacy and safety data.[6] Indian population being commonly
most efficacious antiscabetic. Hence, it was decided to study
and compare three antiscabetics - the most commonly used
benzyl benzoate, the currently considered medicine of choice
permethrin, and the most recently introduced ivermectin ñ in
the local population of Nagpur.
Aim
To provide better and improved treatment option for scabies
based on cost effectiveness, efficacy, and safety profile.
Objectives
ï To study the different available treatment modalities in
scabies.
ï To compare efficacy and cost effectiveness of three
treatment modalities and suggest the best intervention for
cure and to find most economical therapy.

Indian J Pharmacol | Feb 2009 | Vol 41 | Issue 1 | 9-14 9

Bachewar et al.: Comparison of benzyl benzoate, permethrin and ivermectin in scabies
Materials and Methods
Study design
This was a prospective, randomized, parallel, noncrossover,
comparative, controlled clinical trial, approved by Ethics
Committee of Government Medical College and Hospital, Nagpur
(GMCN), conducted in patients attending the OPD of Skin and
Venereal Disease Department of GMCN from 15th March to
23rd July, 2007. Dermatologist diagnosed patients of scabies
were approached with request to participate in the trial with a
detailed information sheet. Diagnosis of the disease was based
on clinical symptoms and clinical history.
Patients willing to participate were screened by applying
the inclusion and exclusion criteria. Inclusion criteria included
newly diagnosed patients of scabies, of either gender, above 12
years of age, willing to participate, and give written informed
consent. For inclusion, the patients had to satisfy at least three
out of the five criteria viz. history of contact with a scabies
patient, complaint of nocturnal itching, history of involvement
of family members, presence of classical burrows on clinical
examination, and presence of typical scabetic lesions like
papules, nodules, or vesicles.
Exclusion criteria included pregnant or lactating women;
women of child bearing age or planning for conception in near
future; participants with abnormal liver and kidney functions,
known thyroid disease, cardiac disorders, nervous system
disorders, and psychiatric illnesses; and participants with
history of diabetes mellitus, hypertension, or chronic infectious
diseases. Participants taking any concurrent medication for
other illness, consuming tobacco in any form, alcohol, or any
substance of abuse were excluded from the trial. Participants
with any other associated skin disease, which could alter the
picture of scabies; known/suspected immunocompromised
individuals, having scabies with atypical presentations like
crusted scabies or scabies incognito; participants who had
taken any antiscabetic treatment in the preceding week;
and noncompliant participants were excluded. In this trial
ivermectin was given as supervised[7] medication along with
printed handouts of ìdoísî in the local vernacular language.
During their second visit, those participants who failed to
answer correctly the method of application followed by them
and the treatment of fomite were considered as noncompliant.
Participants were first treated for the secondary infection,
if present, with azithromycin 500 mg once daily for three days/
ampicillin 500 mg 6 hourly for five days, as per clinical judgment
of the senior dermatologist and subsequently included in the
trial. The demographic data of the participants like age, gender,
occupation, education, and marital status were collected in
the case record form (CRF) by the principle investigator (PI).
At each visit the participant was examined by two doctors, a
dermatologist and the PI. The 103 enrolled participants were
allocated to three groups according to random allocation
number generated through computer and provided with any
one of the chosen three therapeutic interventions. Participants
were advised not to use or mix any other treatment, including
antipruritic or antihistaminic medicines. All participants were
issued 25% benzyl benzoate (BB) lotion for topical application
for the family members and close contacts, as per the standard
10 Indian J Pharmacol | Feb 2009 | Vol 41 | Issue 1 | 9-14
treatment guidelines to check the reinfestation of the trial
participants. Participants were reinforced with the message
about treatment of the family members and other close contacts
during each visit.
Inter ventions
I: Benzyl benzoate 25% lotion to be applied and left overnight
to the whole body below neck for two consecutive nights.
The BB 50 ml lotion sealed and capped amber colored glass
bottle (M/s Deepti Pharmaceuticals, MIDC, Nagpur), was
supplied by Government of Maharashtra. In local market
it was priced at Indian rupee (INR) 11.
II: Permethrin 5% cream to be applied once to the whole body
below neck and left overnight. The commercially available
permethrin PermiteTM BP: 30 g cream, carton covered,
capped aluminum tube (M/s Encube Ethical Private Limited,
Madkaim Industrial estate, Ponda, Goa), was priced at
INR60. Each tube contained 1500 mg active permethrin,
30 mg formaldehyde solution, and cream base.
III: Tablet ivermectin 200 µg/kg to be consumed as a single
dose. The commercially available ivermectin VermectinTM
BP: 6 mg/12 mg scored uncoated tablets, supplied in
carton covered blister pack of single tablet (M/s Μicro Labs
Limited, SIPCOT Industrial Complex, Hosur, Tamil Nadu),
was priced at INR25. Each tablet contained yellow oxide of
iron as coloring agent.
Participants on intervention I and II were advised to bathe
with warm water before application of medication and on
subsequent morning. The participants were recalled after
one week for follow-up evaluation. The same intervention
was repeated if there were no signs of improvement. The
participants were followed up for two weeks for cure rate,
adverse drug reaction (ADR) monitoring, and postintervention
observation. Because of the known safety of all the three
interventions, no laboratory examinations were advised. The
follow-up was stopped after two weeks subject to achievement
of one of the three endpoints ñ participant defined as completely
cured, participant who developed severe ADR, or participant
who was not cured two weeks postintervention follow up.
Cure
During the one week postintervention follow up, both the
doctors examined each participant. The participants who did
not have any new lesions were considered as cured. Papules,
vesicles, and classical burrows were considered as new
lesions suggestive of live parasite. The cured participants
were prescribed antihistaminic for symptomatic treatment
of remaining pruritus and the uncured participants were
prescribed repeat intervention along with antihistaminic. All
the cured as well as uncured participants were again called
after one week for the follow-up examination and recording of
the parameters.
Pruritus
All participants were followed up for one week
postintervention, for improvement of pruritus. Antipruritic
medicines, if needed, were prescribed only after this. After
one week follow up, each participant was asked to quote
0/25/50/75/100%, on the visual analogue scale (VAS) about the
percent of remaining pruritus, considering the pruritus at first
visit as 100%. Thus, pruritus was observed for only one week
 Bachewar et al.: Comparison of benzyl benzoate, permethrin and ivermectin in scabies

postintervention. On each visit, the participants were asked for Cost-effectiveness graph
occurrence of any ADR. In this graph [Figure 1] x-axis shows ∆E, that is, incremental
Statistical analysis effectiveness, y-axis shows ∆C, that is, incremental cost, and
Fisherís exact test was applied using Graph pad Instat λ-line is the arbitrary line differentiating between the zones
version 3.05. The ëPí value of less than 0.05 was considered (zone above the λ-line is unacceptability zone and zone below
as statistically significant. The sample size was calculated the line is acceptability zone).
taking into consideration the future dropouts and was based Incremental cost = cost of the new (second) treatment ñ cost
on previous similar studies.[6] of the old (first) treatment
Incremental effectiveness = efficacy of new (second) treatment
Results ñ efficacy of old (first) treatment
While doing randomized sampling for this study, gender-wise Considering the cure rates at the end of one week, cost
distribution and the follow-up in all the three treatment groups incurred to treat 100 participants for different interventions
was maintained throughout the trial, except the BB group in was found to be:
which we experienced lower follow up in women. The same Total cost of treatment = INR for participants cured with one
ratios as in followed-up groups were maintained in cure rates week treatment + INR for participants who were treated for
at the end of two weeks [Table 1]. two weeks
Living status ñ living singly or with a partner ñ did not show Cost of one bottle of BB was INR11, for one permethrin
any implication over cure rates with any of the treatments. tube was INR60, and that of one 12 mg tablet of ivermectin
Majority (84%) of the participants were from 12ñ41 years age was INR25. With these costs the cost of treatment in INR was
group, showing the usual trend of scabies.[6] Most (85%) of the calculated as:
participants had at least primary education. This confirms Benzyl benzoate = (11 X 76) + (22 X 24) = 1364
their literacy and ability to understand the written instructions Permethrin = (60 X 82.14) + (120 X 17.86) = 7071.6
provided to them. The distribution of typical scabies lesions over Ivermectin = (25 X 55.56) + (50 X 44.44) = 3611
different body parts was variable. To enumerate the important
ones, pubic region lead with 18%, followed by abdomen, wrists,
Figure 1: Cost-effectiveness of benzyl benzoate and ivermectin as
and web space affliction amounting 13% each, and cubital compared to permethrin
region was affected in 11%. Ivermectin was least promising at ∆C - incremental cost, ∆E - incremental efficacy, Red dot - cost
the end of one-week treatment, but it showed 100% cure rate effectiveness of ivermectin (∆C = ñ INR57.08; ∆E = ñ4.43),
after two-week treatment [Table 2]. Blue dot - cost effectiveness of benzyl benzoate (∆C = ñINR34.61;
Considering pruritus as presenting symptom, the medication ∆E = 3.57)
which alleviates it has greater acceptance in clinical practice.
We observed that permethrin qualifies for this, with 76%
decrease in pruritus at the end of one week. Statistical analysis
with Fisherís exact test showed that at the end of one week,
considering the cure rate, only permethrin was significantly (P <
0.05) better than ivermectin. At the end of two-week treatment,
this finding was reversed because the cure rate in ivermectin
group was 100%.
Economic analysis
For this we compared the three interventions on economic
basis and cost effectiveness. The following methods were
used.
Cost effective analysis
On the basis of total expenditure incurred on medicines at
the end of two weeks in INR and cure rate in percentage, the
cost effectiveness was calculated and the three interventions
were compared on the basis of amount needed to treat one
case successfully.

Table 1

Comparison of gender ratios at various stages of clinical trial in the treatment groups

L::
Benzyl benzoate Permethrin Ivermectin Total
(M/F = Ratio) (M/F = Ratio) (M/F = Ratio) (M/F = Ratio)

Participated 23/12 = 1.917 22/12 = 1.833 18/16 = 1.125 63/40 = 1.575

Followed up 18/7 = 2.285 18/10 = 1.8 14/13 = 1.077 50/30 = 1.667
Cured 16/7 = 2.570 17/10 = 1.7 14/13 = 1.077 47/30 = 1.567

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Bachewar et al.: Comparison of benzyl benzoate, permethrin and ivermectin in scabies

Table 2 Figure 2: Markov model of decision analysis for cost effectivness of

different regimens in scabies
Participant response during the trial in each group benzyl benzoate, P - permethrin, I - ivermectin treatment, Red line - not
cured, Black line - cured, Green dotted line - tracing lines
Participant response BB P I
The ìMarkov population model of decision analysisî was prepared
Recruited participants 35 34 34 using our clinical data for efficacy of each intervention at one and two
Followed up at the end of two weeks 25 28 27 weeks. Figures in the box on the right side show cost of treatment. The
numbers in subscript denote duration of treatment in weeks. The tree
Cure rate at end of one week (%) 76 82.14 55.56
has been designed considering 10,000 patient recruitments in each
Cure rate at the end of two weeks (%) 92 96.43 100
branch for easy analysis. Numbers above the horizontal arrow lines
BB - benzyl benzoate, P - permethrin, I - ivermectin show number of patients in that branch.

Amount needed to treat one case of scabies successfully at

the end of one week was least for BB with INR14.47 and it was
most for permethrin with INR73.04 [Table 3].
All the values thus obtained were used for further analysis.
The same parameter at the end of two weeks was again least for
BB with INR14.83 and was most for permethrin with INR73.33.
Thus, permethrin was approximately five times costlier for
treating one scabies case successfully at the end of one- or
two-week treatment [Table 4]
The cost-effectiveness graphs confirm that as compared
to permethrin, BB and ivermectin fall in acceptability zone.
Ivermectin falls at the center of acceptability zone, thereby
suggesting that it is more cost effective than BB [Figure 1].
Markov model of decision analysis[8,9]
ìMarkov model of decision analysisî is a designed tree in
which detailed cost at each step is given at the end of the tree
and total cost of each limb is calculated. Each step follows the
cure rate of that medicine at that step. We calculated the cost
of treatment according to efficacy of each medicine at the end
of one and two weeks as per the results obtained [Figure 2].
In this trial the cure rate of ivermectin was found to be
100% at the end of two-week treatment. We formulated various
regimens after permutations and combinations to gain 100%
cure rate for the treatment of scabies patients in the tertiary for that duration, for example, B2I2 means benzyl benzoate
care institution level. We formulated the regimens considering treatment given for two weeks and then uncured patients
the cure rates of all the three medicines of this trial, which we treated with ivermectin treatment for next two weeks.
got at the end of one- and two-week treatment. The hypothetical Among all the regimens, ivermectin had the shortest duration
regimens were: of two weeks. All the regimens have two-week treatment with
1. B2I2 ivermectin at the end because in this trial we found ivermectin
2. B1I2 having 100% cure rate at the end of two weeks. None of the
3. I2 other two medicines offered such a cure rate.
4. P2I2 Markov population model of decision analysis shows that
5. P1I2 B2I2 is the cheapest regimen, while I2 gives the fastest results
6. B1P1I2 in half the duration with double the cost of B2I2. The third one
where subscript denotes the number of weeks for which the which falls in between is, B1I2, also a cost-effective regimen
treatment is given. The alphabets denote the medicine given giving 100% cure in three weeks.

Table 3

Cost-effectiveness analysis of the trial medicines at the end of one week

Parameters BB P I

Cost in INR for 100 participants 11 X 100 = 1100 60 X 100 = 6000 25 X 100 = 2500
Cure rate (%) (effectiveness) 76 82.14 55.56
Cost effectiveness INR1100 for 76 participants INR6000 for 82.14 participants INR2500 for 55.56 participants
Cost to treat one case (INR) 14.47 73.04 45
BB - benzyl benzoate, P - permethrin, I - ivermectin

12 Indian J Pharmacol | Feb 2009 | Vol 41 | Issue 1 | 9-14

 Bachewar et al.: Comparison of benzyl benzoate, permethrin and ivermectin in scabies
Table 4
Cost-effectiveness analysis of the trial medicines at the end of
two weeks
Parameters BB P I
Cost in INR for 100 participants 1364 7071.6 3611
Cure rate (%) (effectiveness) 92 96.43 100
Cost effectiveness INR1364 INR7071.6 INR3611
for 92 for 96.43 for 100
participants participants participants
Cost to treat one case (INR) 14.83 73.33 36.11
BB - benzyl benzoate, P - permethrin, I - ivermectin
Discussion
Cure rates
The 100% cure rate was obtained with oral ivermectin at the
end of two weeks. Some of the previous studies have reported
similar results,[6,10-12] but the interesting finding was the lesser
decrease in pruritus score with ivermectin as compared to
permethrin. None of the previous studies have reported the
superior efficacy of ivermectin.[12,13] It is presumed that the VAS
used for recording of residual pruritus may have suffered due
to the subjective variation, but then VAS was the best scale that
could have been used in this study.[14,15] Cure rates of participants
in BB group and permethrin group were in the same range as
concluded by previous researchers.[6,11,12,16,17]
Economic studies
The limiting factor in the wide use of permethrin is its
cost.[5,18,11] In another study on cost benefit and safety analysis
of antiscabetic drugs, 5% permethrin was claimed to be
the best option for scabies in infants and young children.[19]
But that study was influenced by cost as well as safety. In
addition, the study was done in infants; hence, we cannot
compare our data with it. Concerns have been raised about
the use of ivermectin in young children and pregnant women,
because there may be more drug penetration through the
immature bloodñbrain barrier.[20]
Safety
In our study, neither patients nor investigators noted any
ADR, alike other studies.[11,13,19,20] The review of literature reveals
significant statistical association between use of ivermectin
and higher mortality and recommends that ivermectin should
not be used for treatment of scabies in the elderly, pending
confirmation of association being causal or serendipitous.[21]
However, many researchers have criticized the methodology
and the conclusion of that study and a FDA review of the
study found no causal relationship between the deaths and
ivermectin.[21,22]
Finding the best option
Karthikeyan et al, gave definition for an ideal antiscabetic, as
that, which is effective against adult and egg, easily applicable,
nonsensitizing, nonirritating, nontoxic, and economical.[5]
Johnston et al, opined that the treatment selected should
be determined by local epidemiology of resistance, drug
toxicity, and particularly in underdeveloped countries, cost
and availability.[23] Chosidow et al, have recommended that
ivermectin should be routinely used in patients who do not show
response to a topical antiscabetic and it may be the appropriate
first choice for the elderly, patients with generalized eczema,
and others who may be unable to tolerate or comply with topical
agents.[4] Chosidow et al, have admitted that optimal therapy for
classic scabies is not certain. Topical treatment may be poorly
tolerated. Oral ivermectin is convenient, but the optimal dosing
regimen remains uncertain.[4] A fact sheet for patients that is
available from the Center for Drug Control, USA, recommends
the use of 5% permethrin as standard therapy with crotamiton
or oral ivermectin as alternatives.[4]
Ivermectin is the future drug of choice for scabies.[5] In France
ivermectin is licensed for human scabies since 2001.[24] The
treatment is easy, quick, safe, and well tolerated with maximal
patient compliance.[24] Our findings show that BB required the
least INR to treat one case of scabies, ivermectin was the most
cost effective single medicine by virtue of its 100% efficacy, and
permethrin gave the fastest symptomatic relief.
After these confounding findings, we tried various
permutations and combinations of regimes to obtain optimum
desirable results, which added to the novelty of this research.
Safetywise, we found the three medicines equal as no ADR was
reported with any of these. Thus, only the cost effectiveness
played the decisive role in selection. On Markov tree for decision
analysis,[8,9] we found BB as the preferred medicine. Our finding
of B2I2 as the most economical regimen recommends that one
should start with BB treatment for scabies afflicted for first two
weeks and then shift the uncured patients to oral ivermectin
therapy for next two weeks.
In another study where oral ivermectin was comapred to
topical 10% BB, it was found that absolute results favored
the use of ivermectin, but the difference was not statistically
significant.[20] A recent trial proved that ivermectin significantly
decreased post-treatment reinfestation as compared to
permethrin, but the cause remained obscure.[25] On the basis
of such results many researchers, regulatory bodies, and WHO
recommend ivermectin use for mass treatment of scabies.[26]
Ivermectin cannot be the best drug in every hospital setting; in
spite of showing promise in its efficacy and safety, as the local
resistance pattern (which we did not find) and the affordability
of patient population varies, and other cheaper alternatives still
have an important role in marginalized economies. We agree
that addition of ivermectin to the clinicianís armamentarium
should be welcomed for the treatment of scabies, as it is the
most cost effective, safe medicine which gives relief in the
shortest possible time.[22]
Currently, permethrin is commonly recommended as the
drug of choice. But in our study it did not get that coveted
position. If we evaluate the best symptomatic treatment which
can give moderate cure rate, permethrin is the answer. It is also
equally safe. However, we did not find it in our recommendation
because of the usual practice of giving additional antipruritic
along with antiscabetics right at the very first visit for
symptomatic benefit to all patients. Additionally, the result of
highest cure rate with permethrin, which we found at the end
of one week, did not sustain after two weeks.
Limitations
We admit that our study was biased due to nonblinding.
Indian J Pharmacol | Feb 2009 | Vol 41 | Issue 1 | 9-14 13
Bachewar et al.: Comparison of benzyl benzoate, permethrin and ivermectin in scabies
Blinding was not possible because the formulations were
different, that is, lotion, cream, and tablet. This study does have
the inherent limitations in Markov population tree of decision
analysis, like nonconsideration of lateral transfer of disease,
reinfestation, and loss to the trial for meeting of any of the
unusual endpoint.
Conclusion
In Government hospital like ours, we recommend that
each patient of scabies should be first advised BB topically
for two weeks. Nonresponders should then be advised oral
ivermectin once a week for two weeks. In case of affording
patients ivermectin once a week for two weeks currently offers
quick, better, and safe results, restricting further morbidity and
secondary transmission. The novel research design of clinical
trial with economic analysis is easy and accurate method
for doing a pragmatic trial, which can be replicated in other
diseases.
Acknowledgments
We are indebted to the staff of Department of Skin and VD,
headed by Dr. R.P Singh, Dr. Rathi, Dr. Riaz, Dr. Shyamal, Dr.
Kirti, and Dr. Piyush. We also thank all the participants of this
clinical trial.
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