Clinical dermatology Original article CED

Clinical and Experimental Dermatology

Efficacy and safety of a lindane 1% treatment regimen for scabies,

confirmed by dermoscopy-guided skin scraping with microscopic
examination
S. E. Park,1 Y. Her,2 S. S. Kim1 and C. W. Kim1
1
Department of Dermatology, Kangdong Sacred Heart Hospital, Hallym University College of Medicine, Seoul, Korea; and 2Department of Dermatology,
School of Medicine, Kangwon National University, Chuncheon, Korea

doi:10.1111/ced.12643

Summary Background. This is the first study investigating scabies treatment since 1992 to
involve examination of patients with microscopically confirmed scabies.
Aim. To assess the efficacy of 1% lindane cream in treating microscopically con-
firmed scabies, and to determine the utility of dermoscopy-guided skin scraping with
microscopic examination (DSGSS-ME) in evaluating the efficacy of scabies treatment.
Methods. This retrospective study analysed patients treated for scabies between
January 2012 and December 2013. From the hospital database, 287 cases of scabies
were identified and 50 were enrolled in the study. Patients were treated with 1% lin-
dane cream twice weekly (days 0 and 1) and were evaluated with DSGSS-ME on
day 7. Treatment and evaluations were repeated once weekly until a negative
DSGSS-ME result was obtained.
Results. The cumulative efficacy of lindane 1% cream was 40% (20/50) after
1 week, 88% (44/50) after 2 weeks and 98% (49/50) after 3 weeks of treatment.
There was a statistically significant difference between the 1- and 2-week
(P = 0.03), and 1- and 3-week (P = 0.02) treatments. A total of 90 post-treatment
DSGSS-MEs were performed, with a sensitivity of 97.3% (95% CI 85.899.9) and a
negative predictive value of 98.2% (95% CI 90.1100). Specificity and positive pre-
dictive value were 100%, as this procedure cannot yield false-positive results,
because it relies on finding mites, eggs or faeces.
Conclusions. We suggest that a twice-weekly schedule (on consecutive days) of
1% lindane treatment lasting at least 2 weeks is required to clear scabies. DSGSS-ME
appears to be a good method to evaluate the efficacy of scabies treatment. This study
introduces a safe and effective method to treat scabies, and to accurately monitor
infestation status in patients.

Introduction Sarcoptes scabiei var. hominis, into the epidermis.1 Glo-

Scabies is a contagious skin infestation caused by the
penetration of the obligate human parasitic mite,
Correspondence: Dr Chul Woo Kim, Department of Dermatology,
Kangdong Sacred Heart Hospital, Hallym University College of Medicine,
150, Sungan-ro, Gangdong-gu, Seoul, 134-701, Korea
E-mail: soeun1703@naver.com
Conflict of interest: the authors declare that they have no conflicts of
interest.
Accepted for publication 21 October 2014
bally, there are approximately 300 million cases of
scabies (5% of the worlds population) every year.2 In
Korea, although the incidence of scabies has decreased
dramatically since the late 1980s, recent outbreaks in
nursing homes or hospitals have raised public health
concerns.3 Dermoscopy is viewed as a sensitive and
valuable tool in diagnosing scabies in vivo.4 It permits
the identification of a triangular or V-shaped structure
corresponding to the fore portion of the mite, includ-
ing the head and legs. Gamma benzene hexachloride

2015 British Association of Dermatologists Clinical and Experimental Dermatology 1

Efficacy and safety of a lindane 1% treatment regimen for scabies  S. E. Park et al.
lotion (or cream) 1%, also known as lindane, has been
used since the 1950s for treatment of scabies and
pediculosis.5
We performed a study to assess the efficacy and
safety of lindane using only microscopically confirmed
cases of scabies. Furthermore, we assessed the diagnos-
tic value of dermoscopy-guided skin scraping with
microscopic examination (DSGSS-ME), and its utility in
evaluating the efficacy of scabies treatment.
Methods
Institutional review board permission was obtained
before the study was conducted, and all patients pro-
vided a signed informed consent form.
Patients
This retrospective study used medical records from the
Department of Dermatology at Kangdong Sacred Heart
Hospital. In total, 287 patients admitted to or treated
at this facility between January 2012 and December
2013 were identified from the hospital database.
Inclusion criteria were age > 18 years at the time of
diagnosis, and positive dermoscopic and microscopic
evidence of scabies. Exclusion criteria were pregnancy
or lactation; history of seizures, severe systemic disor-
ders or immunosuppressive disorders; and presence of
Norwegian scabies.
In total, 287 patients presenting with scabies
between January 2012 and December 2013 were
identified from the hospital database. Of these, 16 were
excluded because they were aged < 18 years, and 58
patients were excluded because they had positive clini-
cal signs but negative DSGSS-ME findings for scabies.
Of the remaining 213 patients, 21 were not able to
return for treatment following a positive microscopic
diagnosis, while 142 patients were excluded because
they were not treated using the regimen being investi-
gated in this study.
The remaining 50 patients were enrolled in the
study [25 men (50%), 25 women (50%); mean  SD
age 64.34  19.07 years, range 2695). The eligible
and ineligible patients had similar clinical characteris-
tics (Table 1), and the ineligible patients were used as
controls.
Dermoscopy-guided skin scraping with microscopic
examination
We have described the inspection method used to
identify scabies mites in a previous report.6 Briefly,
2 Clinical and Experimental Dermatology
Table 1 Clinical characteristics of the included and excluded
patients.
Clinical
parameters Included (n = 50) Excluded (n = 163) P
Sex, n (%) 25/25 (50.0/50.0) 78 (47.9)/85 (52.1) 0.79
Age, years* 64.34  9.07 (2695) 65.72  16.76 (2495) 0.62
Scabies 7.40  6.80 (140) 6.65  5.51 (136) 0.43
duration,
weeks
*Data are mean  SD (range).
dermoscopic identification of mites was performed at
9 10 magnification with a handheld dermoscope
(Dermlite II Pro; 3Gen, San Juan Capistrano, CA,
USA). A triangular structure, followed by a burrow,
was considered to indicate the presence of a mite.
Dermoscopic examination and skin scraping was per-
formed by a dermatologist (CWK), who had over
5 years of experience in dermoscopic identification of
scabies.
Dermoscopic examination was performed on body
areas where burrows are frequently found, such as the
sides of the fingers, the interdigital webs, the flexural
sides of the wrists, and the palms, axillae, umbilical
areas, buttocks and scrotum. A dermoscope was used
to assist in taking skin scrapings from the triangular
structure, which was scraped using a sterile scalpel
after the application of one drop of mineral oil onto
the skin (Fig. 1a). The skin samples were examined at
9 100 magnification. Diagnosis of scabies was based
on the finding of mites, eggs or faeces.
Treatment
We prescribed patients lindane 1% cream (Gammalin;
Tai Guk Pharm Co. Ltd. Seoul, Korea). They were
instructed to apply the cream (30 g/day) from the neck
down twice weekly, on two consecutive days (days 0
and 1). After 12 h, the cream was thoroughly washed
off with soap and water. Patients were instructed to visit
us on day 7 and undergo DSGSS-ME.
Skin scrapings were performed on the triangular
structures (if still present) or at the ends of the
remaining burrows (Fig. 1b) under the dermoscope. If
the examination results were negative, the condition
was considered resolved, and lindane applications were
stopped. If positive, the patient reapplied the cream on
days 7 and 8, and was re-evaluated on day 14. Treat-
ment and evaluation were repeated every week until a
negative DSGSS-ME result was obtained. Patients with
resolution of scabies were followed up for 24 weeks
2015 British Association of Dermatologists
 Efficacy and safety of a lindane 1% treatment regimen for scabies  S. E. Park et al.
(a)
(b)
Figure 1 (a) Two hang-glider-like triangles (arrows) were
observed under 9 10 dermoscopic magnification, indicating sca-
bies mites; (b) trace of a burrow observed 1 week after the final
treatment.
until complete resolution of pruritus and skin lesions.
If pruritus or skin lesions persisted or recurred, DSGSS-
ME was performed again. A positive finding was
considered treatment failure, and the treatment and
evaluation steps were again repeated.
Statistical analysis
Statistical analysis was conducted using SPSS (v18.0;
IBM Inc, Armonk, NY, USA). Student t-test and the v
test were used to examine any differences between the
eligible and ineligible groups. Differences between 1-,
2-, and 3-week treatments were examined using the
v2 test. Observations with a P-value of < 0.05 were
considered statistically significant. The sensitivity,
specificity, positive predictive value (PPV), and nega-
tive predictive value (NPV) of post-treatment DSGSS-
ME are presented as percentages with 95% CIs.
2015 British Association of Dermatologists
Results
Response to lindane
Table 2 outlines the outcomes of lindane therapy. A neg-
ative DSGSS-ME result was obtained in 20 patients
(40%) after 1 week of treatment and in 24 (48%) after
2 weeks of treatment, while 5 (10%) needed treatment
for 3 weeks and 1 needed treatment for 4 weeks to
achieve a microscopically evident resolution. Thus, the
cumulative efficacy of lindane 1% cream with DSGSS-ME
was 40% (20/50 patients) after 1 week of treatment,
88% (44/50) after 2 weeks, and 98% (49/50) after
3 weeks. The differences between the 1-week and 2-week
treatments, and between the 1-week and 3-week treat-
ments were statistically significant (P = 0.03 and
P = 0.02, respectively), but there was no statistically
significant difference between the 2-week and 3-week
treatments (P = 0.19).
All patients with resolved scabies (49 of 50) were
followed up for 24 weeks, and had no signs of pruri-
tus or skin lesions. There was only one case (2%) of
treatment failure, which was an 81-year-old woman
who stopped lindane therapy after a negative DSGSS-
ME finding following 2 weeks of treatment. In this
case, the pruritus and skin lesions persisted, and a
positive microscopic finding was obtained on day 21.
She was treated again on days 21 and 22, and a neg-
ative microscopic finding was obtained on day 28. She
underwent follow-up examinations for three further
weeks until the pruritus and skin lesions resolved.
Table 2 Response to lindane 1% treatments (12-h applications
on the first two consecutive days of each week), with scabies
evaluated on the final day of each week.
Resolution after Cumulative
treatment for: Cases, n (%) cases, n (%) P
1 week 20 (40) 20 (40)
2 weeks 24 (48) 44 (88) 0.03*
3 weeks 5 (10) 49 (98) 0.02, 0.19
4 weeks 1 (2) 50 (100)
Total 50 (100) 50 (100)
*Difference between the 1- and 2-week treatments; difference
between the 1- and 3-week treatments; difference between the
2- and 3-week treatments. This was an 81-year-old woman
who stopped lindane treatment after a negative microscopic find-
ing was obtained after 2 weeks of treatment. A positive micro-
scopic finding was obtained on day 21, resulting in lindane re-
treatment on days 21 and 22. A negative microscopic finding
was obtained on day 28, and the patient remained scabies-free
during the further 3 weeks of follow-up.
Clinical and Experimental Dermatology 3
Efficacy and safety of a lindane 1% treatment regimen for scabies  S. E. Park et al.
Table 3 The diagnostic value of post-treatment dermoscopy-
guided skin scraping with microscopic examination.
Value (95% CI)
Sensitivity (TP/TP + FN) 97.3 (85.899.9)
Specificity (TN/TN + FP) 100
Positive predictive value (TP/TP + FP) 100
Negative predictive value (TN/TN + FN) 98.2 (90.1100)
FN, false negative; FP, false positive; TN, true negative; TP, true
positive.
Value of dermoscopy technique
In total, 90 post-treatment DSGSS-ME examinations
were performed. The sensitivity of post-treatment
DSGSS-ME was 97.3% (95% CI 85.899.9) and the
NPV was 98.2% (95% CI 90.100) (Table 3). The
specificity and PPV were 100% by definition, as this
procedure cannot yield false-positive results.7 The
aforementioned treatment failure DSGSS-ME result
(at day 14) was the only false-negative result.
Adverse events
The treatments were considered cosmetically accept-
able by both patients and guardians (offspring or par-
ents). None of the 50 patients experienced allergic
reactions. The main adverse event (AE) was irritation,
reported by seven patients; however, this was not seri-
ous and did not affect compliance. None of the
patients experienced a worsening of the infestation
during the study.
Discussion
This is the first study of scabies treatments since 1992
to include only patients with microscopically con-
firmed scabies. In summary, we determined a
cumulative resolution rate of 40% (20/50 cases)
after 1 week of treatment with lindane 1% cream,
88% (24 + 20/50 cases) after a 2 weeks and 98%
(29/50 cases) after 3 weeks. There was a statistically
significant difference between the 1-week and 2-week
treatments (P = 0.03), and 1-week and 3-week treat-
ments (P = 0.02), whereas there was no statistically
significant difference between the 2-week and 3-week
treatments (P = 0.18). There was only one case (2%)
of treatment failure, and no serious AEs such as
seizures or respiratory problems, were reported.
Lindane is an insecticide belonging to the chlorin-
ated hydrocarbon family, and is one of eight isomers
of 1-6 hexachlorocyclohexane.5 Lindane has been
used for the treatment of scabies and pediculosis since
4 Clinical and Experimental Dermatology
the 1950s.5 The most common preparation is a 1%
lotion, solution or shampoo.5 Low lindane efficacies
have been reported since 2000. A regimen involving
two 12-h applications of 1% lindane lotion with a
1-week interval was effective in 44.369.1% of
patients at the 24-week follow-up examinations, and
increased to 71.772.9% with another 2 weeks of
treatment.6,8,9 However, most of these studies included
microscopically unconfirmed (clinically suspicious)
patients, and thus the reported efficacies might not be
accurate.
In our study, we used a regimen involving applica-
tions of 1% lindane cream applied twice every week
(on successive days) and left for 12 h before washing;
this regimen was continued until patients showed a
negative microscopic finding. Labelled use of lindane
as a scabicide prescribes a single application to dry,
unwashed skin from the neck, to be left on for 8
12 h, as specified in the manufacturers inserts for lin-
dane.7 In 1992, Amer et al.10 demonstrated the effi-
cacy of a similar regimen, involving applications of
lindane on two successive nights. This regimen
achieved an 84% cure rate, measured 28 days after
treatment, with no serious AEs. In Korea, dermatolo-
gists have used either dual or triple application regi-
menns on successive days, repeated weekly if
necessary.11,12 Thus we hypothesized that our pro-
posed regimen would prove to be an effective and safe
treatment schedule. However, we did not compare the
efficacy and safety of our regimen with those of other
conventional regimens, so further studies are required.
Owing to the toxic effects of lindane, including
neurotoxicity (ataxia, disorientation, tremors, seizures
and death13), depressed liver function, cardiac ar-
rhythmias, altered menstruation14 and aplastic anae-
mia,15 lindane has been used in the USA since 1995
only as second-line therapy after failure of alternatives
such as permethrin and malathion,14 The US Environ-
mental Protection Agency banned the use of lindane
as a commercial pesticide in 2007,13 and California
banned the pharmaceutical use of lindane on the basis
of health and environmental concerns in 2002.16
Such concerns indicate that lindane use should be
minimized. Furthermore, resistance to lindane has
increased in recent years, and there are reports of
several clusters of patients worldwide with lindane-
resistant scabies.17 As only clinical post-treatment
evaluation of scabies is made in most cases (i.e. loss of
pruritus or clearance of skin lesions), and given that
lindane itself can cause skin irritation18 and that sca-
bietic pruritic nodules from which mites cannot be
recovered may persist for several months,17 the
2015 British Association of Dermatologists
 Efficacy and safety of a lindane 1% treatment regimen for scabies  S. E. Park et al.

treatment of scabies with lindane is often prolonged method for scabies diagnosis and post-treatment
unnecessarily. Because of these problems, lindane ther- evaluation.
apy may well fade out in the near future in all coun-
tries. However, in Korea, the only commercial
medications for treating scabies are lindane and cro- Whats already known about this topic?
tamiton. However, the efficacy of crotamiton against
Gamma benzene hexachloride (lindane) 1%
scabies is low, and thus the only effective scabicide
lotion/cream has been used since the 1950s for
that can be prescribed to adults is lindane.
treatment of scabies and pediculosis.
Several studies have compared the efficacy and
The use of 9 10 magnification using a pocket
safety of oral ivermectin and 5% topical permethrin
handheld dermoscope has been recognized as a
with topical 1% lindane cream for treating scabies.6,8,9
valuable tool in diagnosing common scabies.
In those studies, the authors concluded that ivermec-
There have been no reports on the safety and
tin or permethrin are superior to lindane lotion if the
efficacy of lindane in Korea.
treatment is repeated after 4 weeks. However, iver-
mectin and permethrin are not available commercially
in Korea and lindane is still widely prescribed. Conse-
quently, we performed this study with lindane to dem-
onstrate the diagnostic accuracy of DSGSS-ME, and to What does this study add?
assess the efficacy and safety of our lindane regimen
We recommend a twice-weekly 1% lindane
to help avoid misuse of the treatment in patient who
treatment schedule lasting at least 2 weeks for
are only clinically suspected of having scabies.
scabies if only clinical post-treatment evaluations
The use of 9 10 magnification with a pocket
are made.
handheld dermoscope has been recognized as a valu-
Although dermoscopy has not yet been accepted
able tool in diagnosing common scabies.19 Dupuy
as a general diagnostic method for scabies, DSGSS-
et al.19 reported sensitivities of 91% (95% CI 8696%)
ME appears to be an effective method for scabies
for in vivo dermoscopic mite identification, and 90%
diagnosis and post-treatment evaluation.
(95% CI 8596%) for microscopic examination of skin
scrapings (P = 0.005 for noninferiority). In our previ-
ous study,20 we demonstrated that the use of dermos-
copy improved the accuracy and speed of scabies Acknowledgement
diagnosis in skin scrapings. The detection rate
This research was supported by Hallym University
achieved by skin scraping with dermoscopy was
Research Fund 2014 (HURF-201418).
approximately twice that of scraping only (41/49 vs.
23/49).20
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2015 British Association of Dermatologists