Comparison of efficacy of intralesional Injection Vitamin D3 with intralesional MMR vaccine in the management of cutaneous warts

Phase 3

Recruiting

• Conditions: Cutaneous warts; Viral wart, unspecified,

• Registration Number: CTRI/2023/05/053231
• Lead Sponsor: INHS Asvini dermatology dept

Brief Summary

All clinically and dermoscopically diagnosed immunocompetent patients of cutaneous warts (aged 5-70 years) attending dermatology OPD at a tertiary care hospital in western Maharashtra within study period would be offered to participate in the study.

- All patients who would agree and fulfill inclusion criteria would be selected. A written and informed consent of the patient would be taken prior to the procedure.

- Clinical examination of the study population with recording of number, site and size of the warts (on millimetre scale) and clinical photographs would be taken. In case of multiple warts, the size of all the warts would be

calculated for assessing the response. Semitransparent paper would be used to map and measure the warts.

• Simple randomization would be done with consecutive patients and they will receive the intervention according to the treatment group with Group A (intralesional vitamin D3) and Group B (intralesional MMR Vaccine).

• Group A- will receive intralesional Vitamin D3 into the base of largest wart.

• Group B- will receive intralesional MMR  into the base of largest wart.

• All treatments to be continued for 4 sessions (2 weeks apart). In case of resolution of largest wart, next largest wart will be injected till completion of total four dosages overall. Photographs would be taken at every session and till 6 months of last dose. Response would be recorded as resolution of injected warts as excellent (75-100%), good (50-74%), partial (25-49%), poor response(0-24%). Similarly response would be seen in distant warts.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-06-06
• Last Update Posted: 2023-12-11

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

All diagnosed immunocompetent cases (clinically and dermoscopically) of cutaneous warts (aged 5-70 yrs) attending Dermatology OPD in a tertiary care hospital in Mumbai.

Exclusion Criteria

• Patients with keloidal tendencies.
• (2) Patients with prior allergic response to MMR or vitamin D3.
• (3)Patients with autoimmune conditions.
• (6) Pregnant /lactating females.
• (7) Known case of HIV/HBsAg/HCV (8)Immunosuppressed patients.
• (9) Consent Denial, uncooperative patients.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Percentage of resolution of injected warts.	Resolution of warts at weeks 2, 4, 6,24

Secondary Outcome Measures

Name	Time	Method
To compare effect of intralesional Vitamin D3 vs MMR vaccine on the resolution of distant warts, other than injected warts	weeks 2,4,6,24

Trial Locations

Locations (1)

INHS Asvini; 🇮🇳 Mumbai, MAHARASHTRA, India

INHS Asvini

🇮🇳Mumbai, MAHARASHTRA, India

Chrisinder Kaur

Principal investigator

917017520062

kaurchrisinderkaur@gmail.com