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: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: B.P. Koirala Institute of Health Sciences
• Collaborator: Nepal Health Research Council
• Treatments: Vitamin D

Criteria

Inclusion Criteria:

1. Clinically diagnosed patients who have more than three warts or single wart in difficult to treat sites (periungual, palms and soles)

Exclusion Criteria:

1. Patients not under any systemic or topical treatment of warts for the last four weeks

2. Patients with a past history of an allergic response to MMR or any other vaccine or Vitamin D

3. Patients with current acute febrile illness or any bacterial infection

4. Immunosuppressed patients

5. Pregnant or lactating women

6. Patients having a past history of asthma, allergic skin disorders or convulsions

7. Patients with keloidal tendency

8. Patient refusal for consent

9. Treating physician's decision to give other treatment modality

10. Patients with hypervitaminosis D, muscle weakness, bone pain, altered sensorium