Trial Outcomes & Findings for A Comparative Study to Assess Efficacy of Intralesional MMR Vaccine and Intralesional Vitamin D3 in Treatment of Warts (NCT NCT04428359)
NCT ID: NCT04428359
Last Updated: 2021-04-09
Results Overview
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%)
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
66 participants
Primary outcome timeframe
Starting of treatment to end of three months follow-up after completing treatment
Results posted on
2021-04-09
Participant Flow
Participant milestones
| Measure |
Measles, Mumps, Rubella Vaccine
All Group A patients will receive intralesional MMR.
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.
|
Vitamin D3
All Group B patients will receive intralesional Vitamin D3
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
|
|---|---|---|
|
Overall Study
STARTED
|
33
|
33
|
|
Overall Study
COMPLETED
|
31
|
30
|
|
Overall Study
NOT COMPLETED
|
2
|
3
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Comparative Study to Assess Efficacy of Intralesional MMR Vaccine and Intralesional Vitamin D3 in Treatment of Warts
Baseline characteristics by cohort
| Measure |
Measles, Mumps, Rubella Vaccine
n=31 Participants
All Group A patients will receive intralesional MMR.
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.
|
Vitamin D3
n=30 Participants
All Group B patients will receive intralesional Vitamin D3
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
|
Total
n=61 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
22.32 years
STANDARD_DEVIATION 11.167 • n=5 Participants
|
23.93 years
STANDARD_DEVIATION 8.383 • n=7 Participants
|
23.11 years
STANDARD_DEVIATION 9.847 • n=5 Participants
|
|
Sex: Female, Male
Female
|
16 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
15 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
31 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Brahmin/ Chhetri
|
9 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Madhesi
|
2 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Janajati
|
18 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
32 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Others
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Region of Enrollment
Nepal
|
31 participants
n=5 Participants
|
30 participants
n=7 Participants
|
31 participants
n=5 Participants
|
|
ITT population
|
31 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
61 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Starting of treatment to end of three months follow-up after completing treatmentPercentage 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%)
Outcome measures
| Measure |
Measles, Mumps, Rubella Vaccine
n=31 Participants
All Group A patients will receive intralesional MMR.
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.
|
Vitamin D3
n=30 Participants
All Group B patients will receive intralesional Vitamin D3
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
|
|---|---|---|
|
Efficacy of IL MMR and IL Vitamin D3 in Treatment of Warts
Complete response
|
25 Participants
|
22 Participants
|
|
Efficacy of IL MMR and IL Vitamin D3 in Treatment of Warts
Excellent response
|
2 Participants
|
6 Participants
|
|
Efficacy of IL MMR and IL Vitamin D3 in Treatment of Warts
Good response
|
3 Participants
|
1 Participants
|
|
Efficacy of IL MMR and IL Vitamin D3 in Treatment of Warts
Poor or no response
|
1 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: At the time of enrollmentDistribution of wart patients into different education level like professional degree, graduate, intermediate, high school, middle school, primary school or illiterate
Outcome measures
| Measure |
Measles, Mumps, Rubella Vaccine
n=31 Participants
All Group A patients will receive intralesional MMR.
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.
|
Vitamin D3
n=30 Participants
All Group B patients will receive intralesional Vitamin D3
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
|
|---|---|---|
|
Number of Participants in Each Education Level Group
Graduate and higher
|
2 Participants
|
4 Participants
|
|
Number of Participants in Each Education Level Group
Intermediate
|
4 Participants
|
2 Participants
|
|
Number of Participants in Each Education Level Group
High School
|
16 Participants
|
20 Participants
|
|
Number of Participants in Each Education Level Group
Middle School
|
6 Participants
|
3 Participants
|
|
Number of Participants in Each Education Level Group
Primary and informal
|
3 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: At the time of enrollmentNumber of participants with different occupations like professional, semiprofessional, clerical/shop/farm, skilled worker, semiskilled worker, unskilled worker, unemployed
Outcome measures
| Measure |
Measles, Mumps, Rubella Vaccine
n=31 Participants
All Group A patients will receive intralesional MMR.
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.
|
Vitamin D3
n=30 Participants
All Group B patients will receive intralesional Vitamin D3
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
|
|---|---|---|
|
Number of Participants in Each Occupation Group
Semiprofessional
|
1 Participants
|
3 Participants
|
|
Number of Participants in Each Occupation Group
Clerical/shop/farmer
|
2 Participants
|
3 Participants
|
|
Number of Participants in Each Occupation Group
Semiskilled
|
1 Participants
|
4 Participants
|
|
Number of Participants in Each Occupation Group
Unskilled
|
1 Participants
|
1 Participants
|
|
Number of Participants in Each Occupation Group
Unemployed
|
3 Participants
|
1 Participants
|
|
Number of Participants in Each Occupation Group
Student
|
18 Participants
|
13 Participants
|
|
Number of Participants in Each Occupation Group
Homemaker
|
5 Participants
|
5 Participants
|
SECONDARY outcome
Timeframe: At the time of enrollmentDuration of warts
Outcome measures
| Measure |
Measles, Mumps, Rubella Vaccine
n=31 Participants
All Group A patients will receive intralesional MMR.
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.
|
Vitamin D3
n=30 Participants
All Group B patients will receive intralesional Vitamin D3
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
|
|---|---|---|
|
Duration
|
24.2977 months
Standard Deviation 23.99027
|
26.2417 months
Standard Deviation 24.28020
|
SECONDARY outcome
Timeframe: At the time of enrollment and at the end of three months follow- up after completion of treatmentQuality 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 .
Outcome measures
| Measure |
Measles, Mumps, Rubella Vaccine
n=31 Participants
All Group A patients will receive intralesional MMR.
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.
|
Vitamin D3
n=30 Participants
All Group B patients will receive intralesional Vitamin D3
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
|
|---|---|---|
|
Effect of the Warts on Patient's Life as Assessed by Dermatological Life Quality Index
no effect at all on patient's life
|
9 Participants
|
10 Participants
|
|
Effect of the Warts on Patient's Life as Assessed by Dermatological Life Quality Index
small effect on patient's life
|
15 Participants
|
17 Participants
|
|
Effect of the Warts on Patient's Life as Assessed by Dermatological Life Quality Index
moderate effect on patient's life
|
6 Participants
|
1 Participants
|
|
Effect of the Warts on Patient's Life as Assessed by Dermatological Life Quality Index
very large effect on patient's life
|
1 Participants
|
2 Participants
|
|
Effect of the Warts on Patient's Life as Assessed by Dermatological Life Quality Index
extremely large effect on patient's life
|
0 Participants
|
0 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: At the time of enrollmentNumber of warts in patients
Outcome measures
| Measure |
Measles, Mumps, Rubella Vaccine
n=31 Participants
All Group A patients will receive intralesional MMR.
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.
|
Vitamin D3
n=30 Participants
All Group B patients will receive intralesional Vitamin D3
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
|
|---|---|---|
|
Number of Warts
|
21.58 Warts
Standard Deviation 22.344
|
21 Warts
Standard Deviation 31.107
|
OTHER_PRE_SPECIFIED outcome
Timeframe: At the time of enrollmentSize range of warts
Outcome measures
| Measure |
Measles, Mumps, Rubella Vaccine
n=31 Participants
All Group A patients will receive intralesional MMR.
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.
|
Vitamin D3
n=30 Participants
All Group B patients will receive intralesional Vitamin D3
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
|
|---|---|---|
|
Size
|
1.242 cm
Standard Deviation 0.9359
|
0.937 cm
Standard Deviation 0.5404
|
OTHER_PRE_SPECIFIED outcome
Timeframe: At the time of enrollmentNumber of participants with different progressions of warts like Gradual or rapid or stable or regressing lesions
Outcome measures
| Measure |
Measles, Mumps, Rubella Vaccine
n=31 Participants
All Group A patients will receive intralesional MMR.
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.
|
Vitamin D3
n=30 Participants
All Group B patients will receive intralesional Vitamin D3
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
|
|---|---|---|
|
Number of Participants With Each Progression Type
Gradual
|
23 Participants
|
27 Participants
|
|
Number of Participants With Each Progression Type
Rapid
|
8 Participants
|
3 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: At the time of enrollmentFrequency of different types of past treatment taken- either traditional or medical treatments
Outcome measures
| Measure |
Measles, Mumps, Rubella Vaccine
n=31 Participants
All Group A patients will receive intralesional MMR.
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.
|
Vitamin D3
n=30 Participants
All Group B patients will receive intralesional Vitamin D3
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
|
|---|---|---|
|
Number of Participants Who Had Taken Past Treatment
None
|
21 Participants
|
19 Participants
|
|
Number of Participants Who Had Taken Past Treatment
Traditional
|
2 Participants
|
1 Participants
|
|
Number of Participants Who Had Taken Past Treatment
Medical
|
8 Participants
|
10 Participants
|
Adverse Events
Measles, Mumps, Rubella Vaccine
Serious events: 0 serious events
Other events: 31 other events
Deaths: 0 deaths
Vitamin D3
Serious events: 6 serious events
Other events: 30 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Measles, Mumps, Rubella Vaccine
n=31 participants at risk
All Group A patients will receive intralesional MMR.
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.
|
Vitamin D3
n=30 participants at risk
All Group B patients will receive intralesional Vitamin D3
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
|
|---|---|---|
|
Renal and urinary disorders
Hypervitaminosis D
|
0.00%
0/31 • 6 months
|
20.0%
6/30 • 6 months
|
Other adverse events
| Measure |
Measles, Mumps, Rubella Vaccine
n=31 participants at risk
All Group A patients will receive intralesional MMR.
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.
|
Vitamin D3
n=30 participants at risk
All Group B patients will receive intralesional Vitamin D3
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
|
|---|---|---|
|
Skin and subcutaneous tissue disorders
Pain
|
100.0%
31/31 • Number of events 31 • 6 months
|
100.0%
30/30 • Number of events 30 • 6 months
|
|
Skin and subcutaneous tissue disorders
Swelling
|
0.00%
0/31 • 6 months
|
60.0%
18/30 • Number of events 18 • 6 months
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
3.2%
1/31 • Number of events 1 • 6 months
|
16.7%
5/30 • Number of events 5 • 6 months
|
|
Skin and subcutaneous tissue disorders
Hyperpigmentation
|
3.2%
1/31 • Number of events 1 • 6 months
|
30.0%
9/30 • Number of events 9 • 6 months
|
|
Skin and subcutaneous tissue disorders
Hypopigmentation
|
6.5%
2/31 • Number of events 2 • 6 months
|
6.7%
2/30 • Number of events 2 • 6 months
|
Additional Information
Dr. Bibisha Baaniya
BP Koirala Institute of Health Sciences
Phone: 9841744777
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place