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Journal of Dermatology & Dermatologic Surgery 20 (2016) 107114

A comparative study of topical 10% KOH solution and topical


25% podophyllin solution as home-based treatments
of molluscum contagiosumq
Nameer K. Al-Sudany a,, Dler R. Abdulkareem b
a

Ibn Sina University of Medical and Pharmaceutical Sciences, Department of Dermatology, Baghdad, Iraq
b
Al-Yarmouk Teaching Hospital, Department of Dermatology, Baghdad, Iraq
Received 6 January 2016; accepted 14 February 2016
Available online 24 February 2016

Abstract
Background: Molluscum contagiosum is a common self-limiting viral infection of the skin. Many therapeutic agents have been used
with varying success rates. Objective: To evaluate and compare the eectiveness of topical 10% KOH solution and 25% podophyllin solution as home-based treatments of molluscum contagiosum. Patients and methods: This open randomized comparative therapeutic trial
was conducted in the department of dermatology, Al-Yarmouk Teaching Hospital, Baghdad, Iraq between January and October 2015.
The patients were divided randomly into two equal groups. Group A patients were treated with 10% KOH solution and those in group B
with 25% podophyllin solution. All patients were assessed weekly for 4 weeks for therapeutic response. Results: Fifty-two patients (age:
234 years) with MC were enrolled in this study, 25 patients in group A and 20 patients in group B completed the study. Sixteen (64%)
patients in group A showed complete clearance of lesions versus 14 (70%) patients in group B. No systemic side eects were reported in
both groups and the local side eects were comparable between both groups. Conclusion: Both 10% KOH solution and 25% podophyllin
solution are eective local therapies for the treatment of MC with comparable success rates (64% and 70% respectively).
2016 The Authors. Production and hosting by Elsevier B.V. on behalf of King Saud University. This is an open access article under the CC BYNC-ND license (http://creativecommons.org/licenses/by-nc-nd/4.0/).
Keywords: Molluscum contagiosum; KOH solution; Podophyllin solution

1. Introduction
Molluscum contagiosum (MC) is a viral disease caused
by molluscum contagiosum virus (MCV) which is classied
within the Poxvirus family (Sterling, 2010). Approximately
q

The study is an independent one and not funded by any drug


company, academic institute or any health authority.
Corresponding author. Tel.: +964 7712216414; fax: +964 5410584.
E-mail address: nameeralsudany@yahoo.com (N.K. Al-Sudany).
Peer review under responsibility of King Saud University.

Production and hosting by Elsevier

1.8% of the population were aected worldwide by MC


with a higher distribution in the tropical areas (Vos et al.,
2012). The disease is more prevalent in children (peak incidence between 2 and 5 years) (Sterling, 2010; Hanson and
Diven, 2003). A later incidence peak in young adults is
attributable to sexual transmission with lesions more common in the genital area (Hanson and Diven, 2003). There is
a clinical impression that MC is more common in patients
with atopic eczema (Leslie et al., 2005). MCV is passed
directly by skin contact with an infected individual to
produce typical cutaneous and, rarely, mucosal lesions
(Dohil et al., 2006). The average incubation time is between
2 and 7 weeks with a range extending out to 6 months.
Infection with the virus causes acanthotic hyperplasia

http://dx.doi.org/10.1016/j.jdds.2016.02.002
2352-2410/ 2016 The Authors. Production and hosting by Elsevier B.V. on behalf of King Saud University.
This is an open access article under the CC BY-NC-ND license (http://creativecommons.org/licenses/by-nc-nd/4.0/).

108

N.K. Al-Sudany, D.R. Abdulkareem / Journal of Dermatology & Dermatologic Surgery 20 (2016) 107114

and hypertrophy of the epidermis which consists of many


lobes, each lobe made up of many lobules separated from
each other by distinct basement membrane (Sharquie
et al., 2015). Clinically the disease produces a papular eruption of multiple umbilicated lesions. Individual lesions are
discrete, smooth, and dome shaped (Hanson and Diven,
2003). Any cutaneous surface may be involved, but favored
sites include the face, neck, abdomen, arms, thighs, axilla,
and genital areas (Bikowski, 2004). MC is a self-limited disease, which, left untreated, will eventually resolve in
immunocompetent hosts (Chen et al., 2013). In general,
there are four main therapeutic approaches to MC:
1. Physical therapies: like; cryosurgery (Silverberg, 2007),
evisceration (Hanson and Diven, 2003), phenol 10%
with pricking (Chen et al., 2013), curettage (Silverberg,
2007), tape stripping (Valentine and Diven, 2000), photodynamic therapy (Chen et al., 2013), electron beam
therapy (Chen et al., 2013) and laser (Jones and
Muram, 1993; Binder et al., 2008).
2. Chemical destructive agents: like; trichloroacetic acid
(Chen et al., 2013), cantharidin (Chen et al., 2013), benzoyl peroxide 10% (Chen et al., 2013), iodine solution
and salicylic acid (Valentine and Diven, 2000), tretinoin
(Rajouria et al., 2011), podophyllotoxin (Piggott et al.,
2012), podophyllin (Barefoot, 1951) and potassium
hydroxide (KOH) Romiti et al., 2000, 1999.
3. Immune modulators: like; imiquimod (Piggott et al.,
2012), diphencyprone (Chen et al., 2013), cimetidine
(Dohil and Prendiville, 1996) and intralesional candida
antigen (Chen et al., 2013).
4. Antiviral agents: like; cidofovir (Chen et al., 2013) and
subcutaneous IFN-a (Piggott et al., 2012).
The best way to prevent the spread of MC is through
good hygiene. (Centers for Disease Control and
Prevention, 2015)
Many therapeutic agents were used for the treatment of
MC with variable results. KOH in dierent concentrations
has been well studied whereas podophylline solution, to
our best knowledge, wasnt tried in the treatment of MC
except once. The aim of the present study was to evaluate
and compare the eectiveness of topical 10% KOH solution and 25% podophyllin solution as home-based treatments of molluscum contagiosum.
2. Patients and methods
An open comparative therapeutic study was conducted
in the Department of Dermatology and Venereology in
Al-Yarmouk Teaching Hospital, Baghdad-Iraq from 1st
of January 2015 to the end October 2015, where a total
number of 52 patients with MC were enrolled in this
study. The patients enrolled in this study were randomly
allocated into two groups through systematic random
sampling.

A full history was taken from each patient regarding


name, age, sex, occupation, marital status, sexual history,
duration of the disease, family history of similar condition,
past medical history, drug history especially for corticosteroids and other immune suppressants and any previous
treatment modality received for their MCs.
Every patient was examined to assess the number, size
and site of lesions; examination was aided by taking several
photos for each patient using the same digital camera
(Canon Power Shot SX260HS Camera 12.1 Megapixel)
from approximately the same distance and similar view.
Patients excluded from this study included those with
face involvement to avoid any possible side eect especially
of cosmetic concern, those who were previously treated,
pregnant and lactating women, uneducated (unreliable)
patient or his/her guardians and children less than 2 years
old.
An informed consent was obtained from each patient or
his/her parents prior to their inclusion in this study after
full explanation about the nature of the disease, its course
and prognosis and full information about therapeutic
agents intended to be used including the side eects and
method of application were given. An approval of the
Ethics Committee of Scientic Council of Dermatology
and Venereology of Iraqi Board for Medical Specializations was also obtained.
2.1. Preparation of the therapeutic agents
A KOH powder (produced by Sinopharm Chemical
Reagent Co., Ltd., Shanghai, China) was dissolved in distilled water to produce a 10% w/v solution. A podophyllin
resin powder (produced by Baoji Oasier Bio-Tech Co., Ltd.
Baoji, China) was dissolved in tincture benzoin to produce
a 25% w/v solution.
2.2. Method of application
Patients in group A were treated with 10% KOH solution
and those in group B were treated with 25% podophyllin
solution with instructions given to the patients or their guardians to apply the agent topically using cotton swab soaked
in the solution after covering the surrounding area with
petrolatum, making gentle application to the MC lesion
and avoid any spillage over normal skin. First application
of therapeutic agent was done in the outpatient clinic trying
to learn the patients the correct way of application and how
to use it at home. Patients in group A were asked to apply
10% KOH solution once daily at night and those in group
B were instructed to apply 25% podophyllin solution every
other night and wash o 4 h after application.
All patients were asked to attend weekly to the outpatient clinic for evaluation and to use therapeutic agents
for 4 weeks or until the lesions are cleared, whichever was
early. The importance of regular attendance was stressed
upon to prevent defaulting.

N.K. Al-Sudany, D.R. Abdulkareem / Journal of Dermatology & Dermatologic Surgery 20 (2016) 107114

2.3. Evaluation and follow up


All patients were examined at the end of 1st, 2nd, 3rd,
and 4th weeks. On each visit the clinical response to treatment; total disappearance of lesions, decrease in size and
number of lesions and any local or systemic side eect were
evaluated and recorded depending on clinical and photographic assessments. Photographs for lesions were taken
before and after treatment.
The patients were considered as respondent when there
was complete disappearance of the lesion; if there was no
change, the patients were considered as non-respondent;
if there was decrease in the number and size of lesions,
the patients were considered as partial respondent.
If complete response occurred during treatment period,
they were asked to attend one month later to assess for any
recurrence of the lesion, if no response occurred, they were
considered as treatment failure.
2.4. Statistical analysis
Data were coded and fed on a computer. Analysis was
done on SPSS (Statistical Package for Social Science
Enrollment

Analysis, Version 21). Both a descriptive statistics like


mean and SD (Standard Deviation) together with analytic
statistics like Chi-square (v2) test and t-test have been done
when appropriate. P-Values less than 0.05 were considered
signicant. The results were presented in the form of frequency table and graphs.
3. Results
A total of 52 patients have been enrolled in this therapeutic trial. Patients were divided into two equal groups;
each consists of 26 patients. Out of a total of 52 patients
with MC, 25 patients in group A and 20 patients in group
B completed the study. In group A, one patient discontinued the treatment due to noncompliance, and in group B,
six patients did not complete the study, one of them didnt
tolerate the local irritation caused by therapeutic agent he
used while others due to noncompliance (Fig. 1).
The age of patients ranged from 2 to 34 years, with a
mean SD of 10.84 9.02 years, the youngest patient
was 2 years old and the oldest one was 34 years old. The
males outnumbered females (28 vs. 17) with a male to
female ratio 1.6:1. The two groups were well-matched in

Assessed for eligibility (n=60)

Excluded (n=8)
Not meeting inclusion criteria (n=5)
Declined to participate (n=3)

Randomized (n=52)

Allocated to intervention A (n=26)


Received allocated intervention (n=26)
Did not received allocated intervention
(n=0)

Allocation

Follow-up
Lost to follow up due to noncompliance (n=1)
Discontinued intervention (n=0)

Allocated to intervention B (n=26)


Received allocated intervention
(n=26)
Did not received allocated
intervention (n=0)

Lost to follow up due to noncompliance (n=5)


Discontinued intervention due to
severe local irritation caused by
therapeutic agent used (n=1)

Analysis
Analyzed (n=25)
Excluded from analysis (n=0)

109

Analyzed (n=21)
-1 excluded from analysis due to
missing data

Figure 1. Flowchart of participants progress through the phases of the trial.

110

N.K. Al-Sudany, D.R. Abdulkareem / Journal of Dermatology & Dermatologic Surgery 20 (2016) 107114

terms of pre-treatment clinical parameters and there was


no signicant variation between them in terms of age and
gender (Table 1).
The duration of the disease among all patients ranged
from 2 weeks to 6 months and a family history of MC
was positive in 18 out of the 45 patients (40%).
The number of lesions per patient ranged from 1 to 75
lesions with a mean SD of 8.95 9.32 lesions and the
total number of lesions was 403 lesions. Thirty-nine
(86.6%) patients had 115 lesions, 4 (8.9%) patients had
1630 patients and 2 patients had more than 30 lesions.
At the end of the study, 16 (64%) out of 25 patients in
group A showed complete clearance of lesions [181
(82.3%) lesions out of 220], while cases in group B showed
total clearance of lesions in 14 (70%) out of 20 patients with
143 (78.1%) lesions out of 183 (Table 2). The results of both
groups were comparable and there was no signicant dierence between them (P-value > 0.67). The time needed for
complete clearance of MC lesions in both groups ranged
from 1 to 4 weeks (Table 3). Therapeutic response for both
10% KOH solution and 25% podophyllin solution is shown
in (Figs. 25).
During the study period no systemic side eect in both
groups was encountered whereas local side eects were
reported in 72% and 75% in group A and group B respectively (Table 4).
At follow up visit (one month after stopping the
treatment), 5 (25%) out of 20 patients used podophyllin

treatment developed new lesions whereas new lesions were


seen in 2 (10%) out of 25 patients who were treated with
KOH solution at new sites other than those previously
involved. No recurrence of any treated lesions in patients
of both groups could be detected.
All side eects were transient and lasted just few weeks
and had totally disappeared.
4. Discussion
In last few years, MC seems to be so common among
Iraqi patients especially children and a large proportion
of those patients or their guardians seek a suitable therapy
which is asked to be non-painful, non-disguring and with
an acceptable cost. Many topical therapeutic agents had
been tried in the treatment of MC with variable success
rates, these included: phenol solution with a success rate
(clearance of lesions) of (41%) Chen et al., 2013, TCA solution (60%) Goyal et al., 2014, salicylic and lactic acids
(100%) Kse et al., 2013, cantharidin (23%) Chen et al.,
2013, benzoyl peroxide (Chen et al., 2013), tretinoin
(45%) Goyal et al., 2014, diphencyprone (64%) Kang
et al., 2005, cidofovir (93%) Hanson and Diven, 2003;
Chen et al., 2013, podophyllotoxin (92%) Markos, 2001,
and imiquimod (7582%) Seo et al., 2010.
Since 1999, KOH solution in dierent concentrations
(2.520%) is tried in the treatment of MC (Romiti et al.,
1999; Kse et al., 2013; Mahajan et al., 2003; Ucmak

Table 1
The frequency distribution of patients with molluscum contagiosum according to the age, gender and sites of lesions.
Age (Year)

210
1120
2130
P31
Total*
Site

Genitalia
Trunk
Extremities
Total**
*
**

Group A

Group B

Male No. (%)

Female No. (%)

Total No. (%)

Male No. (%)

Female No. (%)

Total No. (%)

11 (44)
3 (12)
3 (12)
0 (0)
17 (68)

7
0
0
1
8

18 (72)
3 (12)
3 (12)
1 (4)
25 (100)

7 (35)
0 (0)
4 (20)
0 (0)
11 (55)

6
1
2
0
9

13 (65)
1 (5)
6 (30)
0 (0)
20 (100)

(28)
(0)
(0)
(4)
(32)

Group A

Group B

(30)
(5)
(10)
(0)
(45)

Total

No. of Patients

Lesions No. and (%)

No. of Patients

Lesions No. and (%)

No. of Patients

Lesions No. and (%)

5
17
11

99 (45)
90 (41)
31 (14)
220 (100)

5
10
9

60 (32.8)
65 (35.4)
58 (31.8)
183 (100)

10
27
20

159 (39.5)
155 (38.5)
89 (22)
403 (100)

Group A (mean SD = 9.56 9.22) years. Group B (mean SD = 12.45 8.73) years. P-Value > 0.284. Total (mean SD of 10.84 9.02) years.
Group A (mean SD of 8.8 11.33) lesions. Group B (mean + SD of 9.15 5.90) lesions. Total (mean SD of 8.95 9.32) lesions.

Table 2
Scores of therapeutic response in the patients with MC in both groups (A) and (B) at the end of 4th week of treatment.
Scores of response

Group A

Group B

No. and (%) of patients

No. and (%) of lesions

No. and (%) of patients

No. and (%) of lesions

Complete clearance
Partial clearance
No response
Total

16 (64)
4 (16)
5 (20)
25 (100)

181 (82.3)
23 (10.4)
16 (7.3)
220 (100)

14 (70)
4 (20)
2 (10)
20 (100)

143 (78.1)
31 (16.9)
9 (4.9)
183 (100)

According to the number of patients P-value > 0.671, Chi Square = 0.18
According to the number of lesions P-value > 0.298, Chi Square = 1.08

N.K. Al-Sudany, D.R. Abdulkareem / Journal of Dermatology & Dermatologic Surgery 20 (2016) 107114

111

Table 3
Time needed for complete clearance of MC lesions in both groups.
Duration of treatment

1 week
2 weeks*
3 weeks
4 weeks
Total
*

Group A

Group B

No. and (%) of patients

No. and (%) of lesions

No. and (%) of patients

No. and (%) of lesions

1 (6.25)
9 (56.25)
3 (18.75)
3 (18.75)
16 (100)

1 (0.5)
106 (58.6)
24 (13.3)
50 (27.6)
181 (100)

3 (21.4)
5 (35.7)
4 (28.6)
2(14.3)
14 (100)

20 (14)
41 (28.7)
67 (46.8)
15 (10.5)
143 (100)

Within two weeks of treatment: P-value < 0.00, Chi Square = 8.67

Figure 2. A photograph showing disappearance of MC lesions in a patient treated with 25% podophyllin solution. (A) Before treatment, (B) After 2 weeks
of treatment.

Figure 3. A photograph showing complete clearance of huge number of MC lesions in a patient treated with 25% podophyllin solution. (A) Before
treatment, (B) after 4 weeks of treatment.

et al., 2014; Can et al., 2014; Short et al., 2006). Romiti


et al. (1999) reported a full remission in 32 out of the 35
(91.4%) patients treated with 10% KOH solution in an
average of 30 days. The same researchers carried out in
the year 2000 another study trying 5% KOH solution and
claimed a (100%) remission rate in an average of six weeks

(Romiti et al., 2000). Short et al in 2006 treated 10 patients


with 10% KOH solution in a placebo-controlled study and
they found 70% clearance rate for KOH versus 20% for the
placebo (Short et al., 2006). Also Can et al. (2014) treated
40 children with MC with 10% KOH solution but with
twice daily application and they reported (92.5%) clearance

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N.K. Al-Sudany, D.R. Abdulkareem / Journal of Dermatology & Dermatologic Surgery 20 (2016) 107114

Figure 4. Disappearance of MC lesions in a patient treated with 10% KOH solution, (A) before treatment, (B) after 4 weeks of treatment.

Figure 5. Disappearance of MC lesions in a patient treated with 10% KOH solution, (A) before treatment, (B) after 4 weeks of treatment.

rate within a mean period of 4 weeks. Ucmak et al. (2014)


treated 25 patients with MC comparing (2.5% and 5%)
KOH solution for 2 months, they found signicant dierence between the success rates (23.1% and 66.7% respectively). Mahajan et al. (2003) treated 27 patients with
20% KOH solution. All treated children were cleared of
their lesions within 17 days of treatment. However, stinging
sensation and postinammatory pigmentation were frequent side eects.
Our result regarding 10% KOH solution in the treatment of MC seems to be comparable with previous

mentioned studies that used same concentration of KOH


and similar duration of treatment (Kang et al., 2005;
Mahajan et al., 2003; Short et al., 2006).
Regarding podophyllin trials in MC, for our best knowledge and search, only came across only one study dating to
1949 done by Barefoot at al. They reported only 3 patients
treated with topical application of 20% podophyllin and all
of them were cured. They considered it as a safe home therapy but requires reliable patients (Barefoot, 1951). We have
found a success rate of 70% of patients treated with 25%
podophyllin solution.

N.K. Al-Sudany, D.R. Abdulkareem / Journal of Dermatology & Dermatologic Surgery 20 (2016) 107114

113

Table 4
Comparison of local side eects noticed in both group (A) and (B).
Side eects

Group (A) No. and (%) of patients

Group (B) No. and (%) of patients

Burning
Erythema
Erosion
Hyperpigmentation
Hypopigmentation
Itching
Total patients with adverse eects

18 (72)
11 (44)
12 (48)
16 (64)
3 (12)
7 (28)
18 (72)

12 (60)
13 (65)
7 (35)
11 (55)
2 (10)
3 (15)
15 (75)

P-Value > 0.684

The present therapeutic trial has found both 10% KOH


and 25% podophyllin solutions to be eective in the treatment of MC with comparable results. In terms of the number of patients cured podophyllin was slightly better than
KOH solution (70% versus 64%) with non-signicant statistical dierence (P > 0.67); while in terms of the number
of lesions cleared o the reverse was true (KOH 82% versus
podophyllin 78%) and also with non-signicant dierence
statistically (P > 0.29).
Many local side eects especially erythema, burning sensation and dyspigmentation were seen in both groups of
patients enrolled in this study. Although the frequency of
these local side eects was slightly higher among patients
treated with podophyllin (75% versus 72%), however the
dierence was statistically insignicant (P > 0.68). All
reported local adverse eects were mild and transient and
disappeared spontaneously shortly after the end of treatment except one patient who suered severe local irritation
caused by podophyllin that prevented him from continuing
the treatment due to intolerability. Most of these local side
eects are similarly reported in many other studies
(Barefoot, 1951; Romiti et al., 2000, 1999; Kse et al.,
2013; Mahajan et al., 2003; Ucmak et al., 2014; Can
et al., 2014; Short et al., 2006). Fortunately, neither systemic side eects nor local scarring were encountered during this study.
5. Conclusion
Both 10% KOH solution and 25% podophyllin solution
are eective local therapies for the treatment of MC with
comparable success rates (64% and 70% respectively).
Conflict of interest
There is no conict of interest associated this study.
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