Triple Antigen vs Monoantigen Immunotherapy for Warts

Study Overview
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Brief Summary
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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
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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.

Official Title
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Triple Intralesional Antigen Immunotherapy Versus Monoantigen in the Treatment of Multiple Recalcitrant Warts

Conditions
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Triple Intralesional Immunotherapy Combination in Multiple Recalcitrant Warts

Intervention / Treatment
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* Biological: Intralesional antigen immunotherapy


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 10 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Parallel assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: purified protein derivative (PPD)<br>Group A | Biological: Intralesional antigen immunotherapy<br>* Randomized double-blinded comparative effectiveness and safety clinical trial<br>* Other names: PPD, Candida antigen, and MMR;|
| Active Comparator: Candida antigen.<br>Group B | Biological: Intralesional antigen immunotherapy<br>* Randomized double-blinded comparative effectiveness and safety clinical trial<br>* Other names: PPD, Candida antigen, and MMR;|
| Active Comparator: Measles, Mumps and Rubella vaccine (MMR).<br>Group C | Biological: Intralesional antigen immunotherapy<br>* Randomized double-blinded comparative effectiveness and safety clinical trial<br>* Other names: PPD, Candida antigen, and MMR;|
| Active Comparator: Triple combination of PPD, Candida antigen and MMR<br>Group D | Biological: Intralesional antigen immunotherapy<br>* Randomized double-blinded comparative effectiveness and safety clinical trial<br>* Other names: PPD, Candida antigen, and MMR;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall complete response of both treated and distant warts |  | within 12 weeks of starting treatment sessions (up to 1 month after the last session, maximum 5 sessions) | 
| Immediate adverse effects |  | during and till 20 minutes after intralesional injection immunotherapy | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Distant wart clearance |  | within 12 weeks of starting sessions | 
| Time to complete clearance |  | within 12 weeks of starting therapy | 
| late adverse effects |  | after each session and till the end of sessions and 6 months-follow-up period | 
| Recurrence |  | For 6 months after complete response | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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triple intralesional immunotherapy, Warts, tuberculin purified protein derivative, Candida antigen, Measles-Mumps-Rubella vaccine, combination immunotherapy