Intralesional injection of tuberculin purified protein derivative (PPD) versus measles, mumps, and rubella (MMR … – Nature.com

A total of thirty clinically confirmed patients of molluscum were recruited for this trial from April 2022 to November 2022. Participants were recruited randomly from the outpatient clinic of the Dermatology and Venerology department et al.-Azhar University Hospital in New Damietta, Egypt. The study was approved by the Damietta Faculty of Medicine Al-Azhar University's Research Ethics Committee (00012367-21-02-002). All participants or their guardians gave their informed consent to participate in the trial6.

Patients of MC who were immune competent, with history of BCG vaccination, above 3years of age and under no concurrent systemic or topical treatment of MC within the past 6weeks was included. Those with history of asthma, febrile illness, immunosuppressive conditions or allergic skin disorders were not included. Moreover pregnant or lactating females were excluded from the study.

Demographic details including age and sex were recorded. Careful medical history and clinical examination as well as baseline characteristics of molluscum lesions, including number, size, and site involved, and duration were recorded at the start of the study and each follow-up visit. Appropriate digital photographs were taken before the start, at each visit and after completion of treatment.

The patients were divided randomly using sealed envelope method into three groups. In group (A) patients, 0.1ml of the MMR antigen was first injected into the forearm and only positive reactors (showing5mm induration at the injection site within 4872h of testing) were included in the study. Included subjects were then injected with 0.1ml (10IU) of MMR vaccine (Trimovax Merieux-Aventis, 0.5ml) in their biggest lesion using an insulin syringe held parallel to the skin surface, with the bevel facing upward. Group (B) included 15 patients who were injected intralesionally with 0.1ml (10IU) of PPD tuberculin (VACSERA, Egypt 2ml vial) in the largest lesion. Group (C) included 15 patients who were injected intralesionally with 0.1ml of normal saline (Otsuka, Egypt) in the largest lesion. Treatments were carried out every three weeks and for 3 treatments or until full clearance whichever was achieved first. Following each treatment patients were instructed to remain at the clinic for 30min for possible signs of immediate hypersensitivity. Patients were followed up for two months from the last treatment session for any sign of recurrence6.

Complete response was considered if lesions had disappeared completely while partial response was considered if regression in lesion size or of more than 50% and no response was considered if lesions persisted as is during the full treatment period (9weeks). Side effects during the course of treatment as pain, itching erythema, edema, induration, ulceration and general systemic action as flu-like symptoms were recorded.

Data were fed to the computer and analyzed using IBM SPSS Corp. Released 2013. IBM SPSS for Windows version 22.0 Armonk, NY: IBM Corp. Qualitative data were described using number and percent. Quantitative data were described using median (minimum and maximum) and mean, standard deviation for parametric data after testing normality using Kolmogrov-Smirnov test. Significance of the obtained results was judged at the (0.05) level.

To estimate the sample size, we used Open Epi program Version 3 and according to: MC response rate (outcome) with Tuberculin Purified Protein Derivative (PPD) 85%, and to investigate the preference of intralesional immunotherapy injection with Measles, Mumps, and Rubella (MMR) Vaccine over Tuberculin Purified Protein Derivative (PPD) and placebo. Assuming alpha error is 5%, 95% confidence level and the study power is 80%. Sample size was established to be at least 7 patients for each study group. To compensate for possible 25% drop off or failure to follow up 15 subjects were selected for each group.

This study protocol was reviewed and approved by ethics committee on human research by Al Azhar faculty of medicine (IRB 00012367-21-02-002). All methods were performed in accordance with the relevant guidelines and regulations. Written informed consents were received from participants upon explanation of the study. Consent for publication was obtained from the participants for publishing the images in the manuscript.

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Intralesional injection of tuberculin purified protein derivative (PPD) versus measles, mumps, and rubella (MMR ... - Nature.com