Triple Intralesional Immunotherapy Combination in Multiple Recalcitrant Warts
Conditions
Keywords
triple intralesional immunotherapy, Warts, tuberculin purified protein derivative, Candida antigen, Measles-Mumps-Rubella vaccine, combination immunotherapy
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.
Interventions
BIOLOGICALIntralesional antigen immunotherapy
Randomized double-blinded comparative effectiveness and safety clinical trial
Sponsors
Zagazig University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Masking description
Double masking
Intervention model description
Parallel assignment
Eligibility
Sex/Gender
ALL
Age
10 Years to 70 Years
Healthy volunteers
No
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
1. Patients with acute febrile illness or past history of asthma. 2. Allergic skin disorders such as generalized eczema and urticaria. 3. Past history of meningitis or convulsions. 4. Pregnancy or lactation.
Design outcomes
Primary
| Measure | 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
| Measure | 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 |
Countries
Egypt
Outcome results
None listed