Blackwell Publishing Inc

PHARMACOLOGY AND THERAPEUTICS

Pediatric Dermatology Vol. 23 No. 3 279281, 2006

Double-Blind, Randomized, Placebo-Controlled Trial of the Use of Topical 10% Potassium Hydroxide Solution in the Treatment of Molluscum Contagiosum
Katherine A. Short, M.R.C.P., L. Claire Fuller, F.R.C.P., and Elisabeth M. Higgins, F.R.C.P.
Department of Dermatology, Kings College Hospital, London, United Kingdom

Abstract: Molluscum contagiosum is a common viral infection of the

skin that frequently affects children. Lesions take between 6 and 18 months to resolve spontaneously and are a source of great embarrassment to both caretakers and children, often affecting attendance at school and limiting social activity. Treatment options to date have been poorly tolerated by children but recent studies have suggested that potassium hydroxide may be benecial. This double-blind, randomized, placebo-controlled study compared 10% potassium hydroxide with placebo (normal saline). Twenty patients, aged 2 to 12 years, were recruited. Parents applied a solution twice daily to lesional skin until signs of inammation appeared. Children were examined by the same observer on days 0, 15, 30, 60, and 90. Seventy percent of children receiving topical potassium hydroxide cleared, compared with 20% in the placebo group. Further dosing studies are required to identify whether weaker concentrations of potassium hydroxide are as efcacious, with less irritancy.

Molluscum contagiosum (MC) is a common, worldwide viral infection of the skin that most frequently affects children of school age. The disease may resolve spontaneously but takes between 6 and 18 months and to do so can cause embarrassment. Therefore, a therapeutic approach is often warranted. In this study we aimed to show that topical 10% potassium hydroxide (KOH) solution is safe and efcacious in the treatment of MC. Potassium hydroxide is a strong alkali known to digest keratin. However, it can cause an irritant skin reaction depending on the concentration used, body region to which it is applied, and individual susceptibility. A recent open study of 35 children demonstrated the benet of
Address correspondence to Katherine A. Short, M.R.C.P., Department of Dermatology, Kings College Hospital, Denmark Hill, London SE5 9RS, UK, or e-mail: kshort@doctors.org.uk.

twice-daily application of topical 10% KOH solution with 32 children clearing in a mean of 30 days (1). A further open study of 20 children showed 100% clearance within 6 weeks when 5% KOH was applied twice daily to lesional skin (2). We aimed to conrm these observations in a double-blind, randomized, placebo-controlled study comparing 10% KOH solution with placebo. METHOD The study was approved by the research and development and research ethics committees at our hospital. Informed consent was obtained in writing from the parents of all

Address correspondence to Katherine A. Short, M.R.C.P., Department of Dermatology, Kings College Hospital, Denmark Hill, London SE5 9RS, UK, or e-mail: kshort@doctors.org.uk.

2006 The Authors. Journal compilation 2006 Blackwell Publishing, Inc.

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TABLE 1. Clinical Data, Efcacy, and Localized Adverse Symptoms of Patients Treated with 10% KOH Solution
Patient no. 1 2 3 4 5 6 7 8 9 10 Age (years) 7 5 2 7 6 9 6 6 4 4 Sex M F F M F F F F F F Lesion sites (and number) Neck (7), trunk (1) Neck (4) Neck (5) Legs (9), arms (7), trunk (8), neck (9) Arm (12), trunk (7) Arms (23), legs (5), axillae (1) Arms (2), trunk (2) Arms (2), legs (60) Neck (10) Neck (5) Previous treatment Nil Nil Nil Nil Nil Nil Nil Nil Nil Nil Response to KOH (in days) Clear (30) No response (90) Withdrew after 2 weeks Clear (30) Clear (60) Clear (30) Clear (30) Clear (60) Clear (30) No response (90) Side effects Nil Nil Severe stinging Nil Nil Nil Severe stinging Postinammatory hyperpigmentation Postinammatory hyperpigmentation Nil

the children recruited. The end point of the study was complete clearance of lesions. A statistician in public health advised that assuming clearance in a mean of 30 days with active treatment (rather than placebo), recruiting 10 patients to each arm of the study would be adequate to achieve 80% power at the 5% level. Therefore, 20 sequential children with MC were recruited from the pediatric dermatology clinic by the observing clinician over a 6-month period. Their ages ranged from 2 to 12 years. Exclusion criteria were known immunodeciency and facial lesions. The following information was recorded: age, sex, site of lesions, previous treatments, response to and side effects of KOH (Table 1), and response to and side effects of placebo (Table 2). Duration of MC lesions prior to treatment was not recorded. Data were collected on a database. No interim analysis was planned as the proposed study time and numbers were relatively small. Both the patients and the observer were blinded, and the children were randomly allocated by the dispensing pharmacist to receive one of two treatments (10% KOH solution or placebo control). Both solutions were dispensed in identical, unlabeled bottles. The sequence was not revealed until the end of the study. The parents or caretakers were given verbal and written instructions outlining how to apply the solution to each lesion twice daily with a cotton swab until the lesions showed signs

of inammation. Treatment was to be discontinued if inammation occurred. The same observer carried out the assessment of therapeutic response on days 0, 15, 30, 60, and 90. Children who achieved complete clinical clearance before the end of the study were re-evaluated 1 month after clearance, and those who developed postinammatory pigmentary change were followed up for an additional 3 months. If new lesions developed during the study, these were also treated and included in the data. RESULTS In total, 95% (n = 19) of those enrolled completed the study. In the group receiving topical 10% KOH (n = 10), 10% (n = 1) withdrew from the study after 2 weeks because of discomfort of the skin localized to the application site, 70% (n = 7) cleared completely, and 20% (n = 2) showed no improvement. There were no partial responses. The average time to clearance was 54 days. Time until development of inammation and ulceration varied greatly according to the sizes and locations of the lesions. Two patients reported severe stinging at the application site, which led to withdrawal from the study in one case, and two reported transient postinammatory hyperpigmentation at the application site. Our hospital serves an ethnically mixed population, and although children with Fitzpatrick

TABLE 2. Clinical Data, Efcacy, and Localized Adverse Symptoms of Patients Treated with Normal Saline Solution
Patient no. 1 2 3 4 5 6 7 8 9 10 Age (years) 4 5 4 5 4 5 8 6 8 6 Sex F M F M F M F F M F Lesion sites (and number) Neck (2) Leg (2), abdomen (1), arm (4) Legs (7) Arm (60) Axillae (10), trunk (5) Neck (8), trunk (2) Arm (2), trunk (12), legs (7) Arms (60) Axillae (15), arms (20), trunk (8), legs (2) Trunk (6) Previous treatment Nil Nil Nil Nil Nil Nil Nil Nil Nil Nil Response to solution (in days) Clear (15) No response (90) No response (90) Clear (30) No response (90) No response (90) No response (90) No response (90) No response (90) No response (90) Side effects Nil Nil Nil Nil Nil Nil Nil Nil Nil Nil

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skin types III to VI were included in the study, the two children who developed pigmentary change had skin type II. In the placebo group, 20% (n = 2) had cleared and 80% (n = 8) had no improvement. No children withdrew as a result of side effects in the placebo group. Although greater than 77% of those completing active treatment cleared compared with 20% in the placebo group, using an intention-to-treat analysis and incorporating the dropout from the KOH arm as a treatment failure, the results were not signicant (chi square = 3.232, p 0.01). This may reect the fact that our study involved small numbers of patients. DISCUSSION Molluscum contagiosum is a common viral infection in children for which parents often seek treatment. A wide variety of physical and chemical modalities have been employed to treat these lesions but there is no universally agreed gold standard, and treatment is often limited by side effects (313). Potassium hydroxide is an alkali known to dissolve keratin, hence it is routinely used to identify fungal elements in skin scrapings. Potassium hydroxide can also cause an irritant reaction in the skin, varying with the concentration, body region to which it is applied, and individual susceptibility (14). Previous studies tested the effectiveness of a 10% KOH aqueous solution applied topically to the skin in the destruction of MC based on its property of dissolving epithelial compounds (1,2). We aimed to conrm this in a doubleblind, randomized, placebo-controlled manner. In our study, 70% of the population receiving topical KOH achieved clearance compared to 20% in the placebo group. Although nearly all subjects reported mild stinging on application of KOH, only one patient was unable to continue because of severe stinging. This patient had lesions on the neck. Two patients developed postinammatory hyperpigmentation, which resolved spontaneously over time. All parents and caretakers reported that the solution was easy to apply and that they preferred to treat their children at home instead of subjecting their child to a more aggressive physical modality of treatment in the hospital setting. No patients had tried alternative treatments prior to topical KOH.

In conclusion, we suggest that topical 10% KOH solution could prove to be a safe, inexpensive, and noninvasive alternative treatment of MC in children. We have begun a dosing study comparing different strengths of topical KOH (2.5% and 5%) to establish the optimal dose for future routine clinical use. REFERENCES
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