A Comparative Study to Assess Efficacy of Intralesional MMR Vaccine and Intralesional Vitamin D3 in Treatment of Warts

NCT04428359 | Completed Results

• 2 other identifiers: IRC/1607/019858 - 2019
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Verruca Viral

Keywords

Warts; Intralesional; MMR; Vitamin D; Immunotherapy

Outcome Measures

Primary Outcomes (1)

• Efficacy of IL MMR and IL Vitamin D3 in Treatment of Warts

  Percentage of patients showing complete response to IL MMR and IL Vitamin D3 Complete response -Complete disappearance of warts including distant ones and skin texture at the site is restored to normal (100%) Excellent response- Reduction in size and number including distant ones and few residual warts still visible (75-99%) Good response- Some reduction in size only including that of distant ones but no decrease in number of warts (50-74%) Poor or no response- No significant change in size and number of warts (0-49%)

  Starting of treatment to end of three months follow-up after completing treatment

Secondary Outcomes (4)

• Number of Participants in Each Education Level Group

  At the time of enrollment

• Number of Participants in Each Occupation Group

  At the time of enrollment

• Duration

  At the time of enrollment

• Effect of the Warts on Patient's Life as Assessed by Dermatological Life Quality Index

  At the time of enrollment and at the end of three months follow- up after completion of treatment

Other Outcomes (4)

• Number of Warts

  At the time of enrollment

• Size

  At the time of enrollment

• Number of Participants With Each Progression Type

  At the time of enrollment

Study Arms (2)

Measles, Mumps, Rubella vaccine

EXPERIMENTAL

All Group A patients will receive intralesional MMR.

Drug: Measles-Mumps-Rubella Vaccine

Vitamin D3

EXPERIMENTAL

All Group B patients will receive intralesional Vitamin D3

Drug: Vit D

Interventions

Measles-Mumps-Rubella Vaccine DRUG

Group A patients will receive intralesional injection of upto 0.5 mL of reconstituted MMR vaccine into a single or a maximum of 5 warts at a time in case of multiple warts. Intralesional injection will be given every three weeks for a maximum of 5 doses or until complete resolution, whichever is earlier.

Also known as: MMR

Measles, Mumps, Rubella vaccine

Vit D DRUG

Group B patients will receive a maximum of 0.5 mL Inj. Vitamin D3 (600,000 IU; 15mg/ml) in each session after injection of IL lignocaine with 31 G insulin syringe. In cases of multiple warts, a maximum of 5 warts will be injected at a time. The session will be done at 3 weekly intervals for a maximum of 5 sessions or until complete resolution of warts, whichever is earlier

Also known as: Vitamin D3

Vitamin D3

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Patients not under any systemic or topical treatment of warts for the last four weeks
• Patients with a past history of an allergic response to MMR or any other vaccine or Vitamin D
• Patients with current acute febrile illness or any bacterial infection
• Immunosuppressed patients
• Pregnant or lactating women
• Patients having a past history of asthma, allergic skin disorders or convulsions
• Patients with keloidal tendency
• Patient refusal for consent
• Treating physician's decision to give other treatment modality
• Patients with hypervitaminosis D, muscle weakness, bone pain, altered sensorium

Sponsors & Collaborators

• B.P. Koirala Institute of Health Sciences: lead
• Nepal Health Research Council: collaborator

Study Sites (1)

BP Koirala Institute of Health Sciences

Dharān, One, 7053, Nepal

Location

Related Publications (39)

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• Raju J, Swamy AV, Swamy BLN RK. Intralesional Measles, Mumps and Rubella (Mmr) Vaccine - an Effective Therapeutic Tool in the Treatment of Wart. J Evid Based Med Healthc. 2016;2(50):8548-8551. doi:10.18410/jebmh/2015/1176

  RESULT

• Rohit V, Gajula N. Role of Intralesional Measles Mumps Rubella Vaccine in Cutaneous Warts : A Case Control Study. 2017;(December):57-60.

  RESULT

• Baaniya B, Marahatta S, Dahal R, Shah N. A Comparative Prospective Study to Assess Efficacy of Intralesional MMR (Measles, Mumps, Rubella) Vaccine and Intralesional Vitamin D3 in Treatment of Nongenital Warts. Health Sci Rep. 2025 May 5;8(5):e70782. doi: 10.1002/hsr2.70782. eCollection 2025 May.

  PMID: 40330772 DERIVED

MeSH Terms

Conditions

Warts

Interventions

Measles-Mumps-Rubella Vaccine; Cholecalciferol

Condition Hierarchy (Ancestors)

Papillomavirus Infections; DNA Virus Infections; Virus Diseases; Infections; Skin Diseases, Viral; Tumor Virus Infections; Skin Diseases, Infectious; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Vaccines, Combined; Vaccines; Biological Products; Complex Mixtures; Measles Vaccine; Viral Vaccines; Mumps Vaccine; Rubella Vaccine; Cholestenes; Cholestanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Sterols; Vitamin D; Secosteroids; Membrane Lipids; Lipids

Results Point of Contact

• Title: Dr. Bibisha Baaniya
• Organization: BP Koirala Institute of Health Sciences

cul.bibisha@gmail.com

9841744777

Study Officials

• Bibisha Baaniya, MBBS

  B.P. Koirala Institute of Health Sciences

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Only patients will be blinded to the randomization and intervention.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Junior Resident

Model Details: Group A - will receive IL MMR Group B- will receive IL Vitamin D3

Study Record Dates

• First Submitted: June 8, 2020
• First Posted: June 11, 2020
• Study Start: June 1, 2020
• Primary Completion: January 15, 2021
• Study Completion: January 30, 2021
• Last Updated: April 9, 2021
• Results First Posted: April 9, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

NE (1)