A Comparative Study to Assess Efficacy of Intralesional MMR Vaccine and Intralesional Vitamin D3 in Treatment of Warts
Status:
Completed
Trial end date:
2021-01-30
Target enrollment:
Participant gender:
Summary
Common warts are papulonodular epidermal lesions caused by human papillomavirus (HPV) usually
by the strains 1, 2, 4, 27 or 57. Cutaneous warts occur in 7% to 10% of the general
population, with a maximum incidence between 12 and 16 years. There are multiple destructive
treatment modalities of wart but they have many adverse effects. Hence immunotherapy is
becoming popular in treatment of warts. It is believed that the injection to the HPV-infected
tissue induces a strong nonspecific pro-inflammatory signal and attracts the
antigen-presenting cells. Which then promotes a Th1 cytokine response and leads to
delayed-type hypersensitivity reaction leading to the eradication of the HPV-infected cells.
We are undertaking a study to evaluate and compare the safety and efficacy of 2 such
immunotherapeutic agents namely, IL measles, mumps and rubella (MMR) vaccine versus IL
vitamin D3 for the treatment of warts.
RESEARCH HYPOTHESIS Null Hypotheses: IL MMR vaccine is not better than IL Vitamin D in the
treatment of wart Alternative hypothesis: IL MMR vaccine is better than IL Vitamin D in the
treatment of wart
Method: A total of 60 patients will be included in the study, 30 in each group. Group A and
Group B patients will be injected with 0.5 ml of IL MMR and 0.5 ml of IL vitamin D3
respectively into a single or a maximum of 5 warts at a time in case of multiple warts. The
IL injection will be given every 3 weeks for a maximum of 5 doses. Clinical assessment will
be done by taking photographs and measurements at baseline, before each treatment session,
and 3 months after the completion of treatment. The response will be evaluated by a decrease
in the size and number of the wart(s) and photographic comparison. The response will be
considered complete if there is a complete clearance of the wart(s), good if the wart(s) will
regress in size by 75-99%, moderate if they regress by 50-74% and no or mild if there will be
a 0-49% decrease in wart(s). Immediate and late side effects of MMR and Vitamin D will be
evaluated after each session. Follow up will be made monthly for 3 months to detect any
recurrence. Quality of life (QoL) will be measured in wart patients, using the Nepali version
of the dermatology life quality index (DLQI) questionnaire before initiation of treatment and
at the end of follow up.
Statistical analysis will be done using Statistical Package for the Social Sciences 10.5
version.