Journal of Clinical and Aesthetic Dermatology

MAY 2018

An evidence-based, peer-reviewed journal for practicing clinicians in the field of dermatology

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16 JCAD JOURNAL OF CLINICAL AND AESTHETIC DERMATOLOGY May 2018 • Volume 11 • Number 5 O R I G I N A L R E S E A R C H clearance from the ethical committee of the institution was obtained. Included patients were 15 to 50 years of age with single or multiple extra-genital warts for duration of at least one month without using anti-wart treatments for the last one month. Exclusion criteria included prior hypersensitivity reaction to MMR antigen, pregnancy/lactation, presence of any active infections (e.g., herpes), tuberculosis, chronic diseases (e.g., diabetes mellitus), hypertension, immunosuppression (e.g., human immunodeficiency virus [HIV]) or if the patient was taking immunosuppressives, and patients who were nonadherent. All of the patients who fulfilled the inclusion criteria underwent clinical examination to confirm the diagnosis of wart. In suspicious cases, a biopsy for histopathological confirmation was done. Detailed history was taken to note the duration, number of warts, and the sites involved. Demographic details including age and sex were noted. Photographic documentation was done. Written consent was obtained from all of the patients. Procedure. Patients were randomized equally into two groups using WinPepe software (ETCETERA.EXE 3.26). Using a sample size calculator tool (University of California, San Francisco, San Francisco, California, USA), keeping Type 1 error as five percent and Type 2 error as 20 percent, the sample size in each group was 71. Keeping the dropout rate in mind, the size was increased to 75 patients per group. The first group was designated as the study group wherein intralesional MMR injection was given, and the second group was designated as the control group wherein intralesional normal saline injection was given. MMR vaccine (TRESIVAC®; Serum Institute of India Pvt. Ltd., Pune, India) is available in a single dose vial of 0.5mL. Prior sensitivity testing was done using a dose of 0.1mL via injection intradermally into the volar aspect of the left forearm. The injected sites were examined after two weeks for immune response in the form of erythema or nodule formation. In sensitized patients, 0.5mL of MMR vaccine after reconstitution with distilled water was injected intradermally into their single largest wart. Injections were given every two weeks until a maximum of five injections was achieved. Similarly, 0.5mL of normal saline was injected into the single largest wart of each member of the control group. Patients were evaluated for response and any adverse effects at each visit. Follow-up was done at every visit and at six weeks and 16 weeks after the last injection. Wart recurrence was assessed at every visit. Blinding. Single-blinding was done, where patients were not informed about their allocated groups, but dermatologists who performed the procedure and noted the responses were informed about the groups. Data analysis. The data were analyzed statistically using GraphPad Prism 7 statistical software (GraphPad Software Inc., La Jolla, California, USA). Mean values with standard deviations (SD) were calculated for quantitative data, and nominal data were presented as percentages. Values were compared using a chi-squared test and t-test, for which a value of probability (p) was calculated. Values of p that were less than 0.05 were considered to be significant. RESULTS A total of 150 patients were included in this study (Figure 1). Of these, 28 patients did not complete the study or were lost to follow-up. Hence, the total number of patients in the sample size was 122, with 72 patients in the MMR study group and 50 patients in the control group. In the MMR group, there were 40 men and 32 women with a mean age of 28.9±9.4 years (Table 1). The duration of warts varied from 1 to 36 months in the MMR group and from 2 to 24 months in the control group. In the MMR study group, subjects had a range of 1 to 12 FIGURE 1. Overview of study TABLE 1. Demographic data of patients PARAMETERS MMR GROUP (N=72) NORMAL SALINE GROUP (N=50) SEX Male 40 27 Female 32 23 AGE Age range 15–48 years 17–50 years Mean age, years 28.9±9.4 33.6±9.2 Variance 90.05 82.155 n: number There is no statistically significant difference (p > 0.05) between the demographic data of the study and control groups.

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