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
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|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||66 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Group A - will receive IL MMR Group B- will receive IL Vitamin D3|
|Masking Description:||Only patients will be blinded to the randomization and intervention.|
|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|
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
- 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%)
- 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
- 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
- Duration [ Time Frame: At the time of enrollment ]Duration of warts
- 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
- Number of Warts [ Time Frame: At the time of enrollment ]Number of warts in patients
- Size [ Time Frame: At the time of enrollment ]Size range of warts
- 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
- 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
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
|BP Koirala Institute of Health Sciences|
|Dharān Bāzār, One, Nepal, 7053|
|Principal Investigator:||Bibisha Baaniya, MBBS||BP Koirala Institute of Health Sciences|