Back to resultsTriple Antigen vs Monoantigen Immunotherapy for Warts
Primary Purpose
Triple Intralesional Immunotherapy Combination in Multiple Recalcitrant Warts
Status
Completed
Phase
Phase 2
Locations
Egypt
Study Type
Interventional
Intervention
Intralesional antigen immunotherapy
Sponsored by
About this trial
This is an interventional treatment trial for Triple Intralesional Immunotherapy Combination in Multiple Recalcitrant Warts focused on measuring triple intralesional immunotherapy, Warts, tuberculin purified protein derivative, Candida antigen, Measles-Mumps-Rubella vaccine, combination immunotherapy
Eligibility Criteria
Inclusion Criteria:
- Multiple (> 3 warts) recalcitrant (at least 6 months duration and who did not respond to at least 2 treatment modalities) warts of different sites, size and duration
Exclusion Criteria:
- Patients with acute febrile illness or past history of asthma.
- Allergic skin disorders such as generalized eczema and urticaria.
- Past history of meningitis or convulsions.
- Pregnancy or lactation.
Sites / Locations
- Zagazig university
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Active Comparator
Active Comparator
Active Comparator
Active Comparator
Arm Label
purified protein derivative (PPD)
Candida antigen.
Measles, Mumps and Rubella vaccine (MMR).
Triple combination of PPD, Candida antigen and MMR
Arm Description
Group A
Group B
Group C
Group D
Outcomes
Primary Outcome Measures
Overall complete response of both treated and distant warts
Immediate adverse effects
Secondary Outcome Measures
Distant wart clearance
Time to complete clearance
late adverse effects
Recurrence
Full Information
NCT ID
NCT05254561
First Posted
February 14, 2022
Last Updated
February 14, 2022
Sponsor
Zagazig University
1. Study Identification
Unique Protocol Identification Number
NCT05254561
Brief Title
Triple Antigen vs Monoantigen Immunotherapy for Warts
Official Title
Triple Intralesional Antigen Immunotherapy Versus Monoantigen in the Treatment of Multiple Recalcitrant Warts
Study Type
Interventional
2. Study Status
Record Verification Date
February 2022
Overall Recruitment Status
Completed
Study Start Date
November 20, 2020 (Actual)
Primary Completion Date
June 20, 2021 (Actual)
Study Completion Date
November 15, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Zagazig University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
Warts can be resistant to treatment or return despite the use of many therapeutic modalities. Combining immunotherapy might contribute to better response rates, particularly in recalcitrant warts, which is a real therapeutic challenge. The purpose of this study was to assess the effectiveness and safety of a triple intralesional immunotherapy combination composed of PPD, Candida antigen and MMR versus either agent alone in the management of multiple recalcitrant warts.
Detailed Description
This study included 160 patients with multiple (>3 warts) recalcitrant (at least 6 months duration and who did not respond to at least 2 treatment modalities) warts of different sites, size and duration, with or without distant warts after approval of the Institutional Review Board of Faculty of medicine, Zagazig university. They were randomly assigned to one of four groups (each with 40 patients): PPD, Candida antigen, MMR, or combination of the 3 antigens. Injections into the biggest wart were repeated every two weeks until clearance or for a total of five sessions.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Triple Intralesional Immunotherapy Combination in Multiple Recalcitrant Warts
Keywords
triple intralesional immunotherapy, Warts, tuberculin purified protein derivative, Candida antigen, Measles-Mumps-Rubella vaccine, combination immunotherapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Model Description
Parallel assignment
Masking
ParticipantInvestigator
Masking Description
Double masking
Allocation
Randomized
Enrollment
160 (Actual)
8. Arms, Groups, and Interventions
Arm Title
purified protein derivative (PPD)
Arm Type
Active Comparator
Arm Description
Group A
Arm Title
Candida antigen.
Arm Type
Active Comparator
Arm Description
Group B
Arm Title
Measles, Mumps and Rubella vaccine (MMR).
Arm Type
Active Comparator
Arm Description
Group C
Arm Title
Triple combination of PPD, Candida antigen and MMR
Arm Type
Active Comparator
Arm Description
Group D
Intervention Type
Biological
Intervention Name(s)
Intralesional antigen immunotherapy
Other Intervention Name(s)
PPD, Candida antigen, and MMR
Intervention Description
Randomized double-blinded comparative effectiveness and safety clinical trial
Primary Outcome Measure Information:
Title
Overall complete response of both treated and distant warts
Time Frame
within 12 weeks of starting treatment sessions (up to 1 month after the last session, maximum 5 sessions)
Title
Immediate adverse effects
Time Frame
during and till 20 minutes after intralesional injection immunotherapy
Secondary Outcome Measure Information:
Title
Distant wart clearance
Time Frame
within 12 weeks of starting sessions
Title
Time to complete clearance
Time Frame
within 12 weeks of starting therapy
Title
late adverse effects
Time Frame
after each session and till the end of sessions and 6 months-follow-up period
Title
Recurrence
Time Frame
For 6 months after complete response
10. Eligibility
Sex
All
Minimum Age & Unit of Time
10 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Multiple (> 3 warts) recalcitrant (at least 6 months duration and who did not respond to at least 2 treatment modalities) warts of different sites, size and duration
Exclusion Criteria:
Patients with acute febrile illness or past history of asthma.
Allergic skin disorders such as generalized eczema and urticaria.
Past history of meningitis or convulsions.
Pregnancy or lactation.
Facility Information:
Facility Name
Zagazig university
City
Zagazig
State/Province
Sharkia
ZIP/Postal Code
44519
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Triple Antigen vs Monoantigen Immunotherapy for Warts
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