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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
160
Randomized double-blinded comparative effectiveness and safety clinical trial
Zagazig university
Zagazig, Sharqia Province, Egypt
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)
Immediate adverse effects
Time frame: during and till 20 minutes after intralesional injection immunotherapy
Distant wart clearance
Time frame: within 12 weeks of starting sessions
Time to complete clearance
Time frame: within 12 weeks of starting therapy
late adverse effects
Time frame: after each session and till the end of sessions and 6 months-follow-up period
Recurrence
Time frame: For 6 months after complete response
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