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

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ClinicalTrials.gov Identifier: NCT04428359
Recruitment Status : Completed
First Posted : June 11, 2020
Results First Posted : April 9, 2021
Last Update Posted : April 9, 2021
Sponsor:
Collaborator:
Nepal Health Research Council
Information provided by (Responsible Party):
Dr. Bibisha Baaniya, B.P. Koirala Institute of Health Sciences

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.


Condition or disease Intervention/treatment Phase
Verruca Viral Drug: Measles-Mumps-Rubella Vaccine Drug: Vit D Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 66 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Group A - will receive IL MMR Group B- will receive IL Vitamin D3
Masking: Single (Participant)
Masking Description: Only patients will be blinded to the randomization and intervention.
Primary Purpose: Treatment
Official Title: A Comparative Study to Assess Efficacy of Intralesional MMR (Measles, Mumps, Rubella) Vaccine and Intralesional Vitamin D3 in Treatment of Warts
Actual Study Start Date : June 1, 2020
Actual Primary Completion Date : January 15, 2021
Actual Study Completion Date : January 30, 2021


Arm Intervention/treatment
Experimental: Measles, Mumps, Rubella vaccine
All Group A patients will receive intralesional MMR.
Drug: Measles-Mumps-Rubella Vaccine
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.
Other Name: MMR

Experimental: Vitamin D3
All Group B patients will receive intralesional Vitamin D3
Drug: Vit D
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
Other Name: Vitamin D3




Primary Outcome Measures :
  1. Efficacy of IL MMR and IL Vitamin D3 in Treatment of Warts [ Time Frame: Starting of treatment to end of three months follow-up after completing treatment ]

    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%)



Secondary Outcome Measures :
  1. Number of Participants in Each Education Level Group [ Time Frame: At the time of enrollment ]
    Distribution of wart patients into different education level like professional degree, graduate, intermediate, high school, middle school, primary school or illiterate

  2. Number of Participants in Each Occupation Group [ Time Frame: At the time of enrollment ]
    Number of participants with different occupations like professional, semiprofessional, clerical/shop/farm, skilled worker, semiskilled worker, unskilled worker, unemployed

  3. Duration [ Time Frame: At the time of enrollment ]
    Duration of warts

  4. Effect of the Warts on Patient's Life as Assessed by Dermatological Life Quality Index [ Time Frame: At the time of enrollment and at the end of three months follow- up after completion of treatment ]

    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. DLQI contains 10 questions that involves 6 sections: symptoms and feelings, daily activities, leisure, work and school, personal relationships and treatment. Questions 1 and 2 assess symptoms and feelings; 3 and 4, daily activities; 5 and 6, leisure; 7, work and school; 8 and 9, personal relationships and 10, treatment.

    The DLQI consists of 10 questions. Each question is given 4 options from not at all effect (score 0) to very much effect (score 3). The minimum and maximum possible score, thus, is 0 and 30 respectively.

    Meaning of DLQI Scores 0-1 = no effect at all on patient's life 2-5 = small effect on patient's life 6-10 = moderate effect on patient's life 11-20 = very large effect on patient's life 21-30 = extremely large effect on patient's life

    .



Other Outcome Measures:
  1. Number of Warts [ Time Frame: At the time of enrollment ]
    Number of warts in patients

  2. Size [ Time Frame: At the time of enrollment ]
    Size range of warts

  3. Number of Participants With Each Progression Type [ Time Frame: At the time of enrollment ]
    Number of participants with different progressions of warts like Gradual or rapid or stable or regressing lesions

  4. Number of Participants Who Had Taken Past Treatment [ Time Frame: At the time of enrollment ]
    Frequency of different types of past treatment taken- either traditional or medical treatments



Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04428359


Locations
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Nepal
BP Koirala Institute of Health Sciences
Dharān Bāzār, One, Nepal, 7053
Sponsors and Collaborators
B.P. Koirala Institute of Health Sciences
Nepal Health Research Council
Investigators
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Principal Investigator: Bibisha Baaniya, MBBS BP Koirala Institute of Health Sciences
  Study Documents (Full-Text)

Documents provided by Dr. Bibisha Baaniya, B.P. Koirala Institute of Health Sciences:
Publications of Results:
Dhope A, Madke B, Singh AL. Effect of Measles Mumps Rubella Vaccine in Treatment of Common Warts. 2018;(2):81-84. doi:10.4103/ijdd.ijdd
Raju J, Swamy A V, Swamy BLN, Raghavendra KR. INTRALESIONAL MEASLES , MUMPS AND RUBELLA ( MMR ) VACCINE-AN EFFECTIVE THERAPEUTIC TOOL IN THE TREATMENT OF WART . doi:10.18410/jebmh/2015/1176
Naseem R, Aamir S. The efficacy of intralesional measles, mumps, rubella (MMR) antigen in treatment of common warts. Pakistan J Med Heal Sci. 2013;7(4):1130-1133.
Sobhy Mohamad N, Badran F, Yakout E. Evaluation of the efficacy of a combination - measles, mumps and rubella vaccine in the treatment of plantar warts. Our Dermatology Online. 2013;4(4):463-467. doi:10.7241/ourd.20134.118
Shah A, Patel D, Ravishankar V. Measles, mumps and rubella vaccine as an intralesional immunotherapy in treatment of warts. Int J Res Med Sci. 2016;4(2):472-476. doi:10.18203/2320-6012.ijrms20160298
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
Rohit V, Gajula N. Role of Intralesional Measles Mumps Rubella Vaccine in Cutaneous Warts : A Case Control Study. 2017;(December):57-60.

Other Publications:
Benton JAL and EC. Verrucas Guidelines for Management. Bmj. 2009;301(6763):1276-1277. doi:10.1136/bmj.301.6763.1276-c

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Responsible Party: Dr. Bibisha Baaniya, Junior Resident, B.P. Koirala Institute of Health Sciences
ClinicalTrials.gov Identifier: NCT04428359    
Other Study ID Numbers: IRC/1607/019
858 - 2019 ( Other Identifier: Nepal Health Research Council )
First Posted: June 11, 2020    Key Record Dates
Results First Posted: April 9, 2021
Last Update Posted: April 9, 2021
Last Verified: April 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Dr. Bibisha Baaniya, B.P. Koirala Institute of Health Sciences:
Warts
Intralesional
MMR
Vitamin D
Immunotherapy
Additional relevant MeSH terms:
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Warts
Papillomavirus Infections
DNA Virus Infections
Virus Diseases
Skin Diseases, Viral
Tumor Virus Infections
Skin Diseases, Infectious
Skin Diseases
Vitamin D
Vitamins
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents