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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| purified protein derivative (PPD) | Active Comparator | Group A |
|
| Candida antigen. | Active Comparator | Group B |
|
| Measles, Mumps and Rubella vaccine (MMR). | Active Comparator | Group C |
|
| Triple combination of PPD, Candida antigen and MMR | Active Comparator | Group D |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intralesional antigen immunotherapy | Biological | Randomized double-blinded comparative effectiveness and safety clinical trial |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Zagazig university | Zagazig | Sharqia Province | 44519 | Egypt |
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| ID | Term |
|---|---|
| D014860 | Warts |
| ID | Term |
|---|---|
| D030361 | Papillomavirus Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
| D007239 | Infections |
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| ID | Term |
|---|---|
| D014373 | Tuberculin |
| ID | Term |
|---|---|
| D000942 | Antigens, Bacterial |
| D001426 | Bacterial Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
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Parallel assignment
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Double masking
|
| after each session and till the end of sessions and 6 months-follow-up period |
| Recurrence | For 6 months after complete response |
| D017193 |
| Skin Diseases, Viral |
| D014412 | Tumor Virus Infections |
| D012874 | Skin Diseases, Infectious |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D000941 |
| Antigens |
| D001685 | Biological Factors |