Clinical trial NCT05254561: 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
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: 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
Lead sponsor: Zagazig University
Sponsor class: OTHER_GOV
First posted: 2022-02-24
Enrollment: 160
Sex: ALL
Minimum age (years): 10
Maximum age (years): 70
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Parallel assignment
Primary purpose: TREATMENT

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.

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:

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.

Primary outcomes:
measure: Overall complete response of both treated and distant warts
timeFrame: within 12 weeks of starting treatment sessions (up to 1 month after the last session, maximum 5 sessions)
measure: Immediate adverse effects
timeFrame: during and till 20 minutes after intralesional injection immunotherapy
Secondary outcomes:
measure: Distant wart clearance
timeFrame: within 12 weeks of starting sessions
measure: Time to complete clearance
timeFrame: within 12 weeks of starting therapy
measure: late adverse effects
timeFrame: after each session and till the end of sessions and 6 months-follow-up period
measure: Recurrence
timeFrame: For 6 months after complete response
Other outcomes:
Locations:
city: Zagazig
country: Egypt
facility: Zagazig university
state: Sharkia
Study officials:
References: