Triple Antigen vs Monoantigen Immunotherapy for Warts

Zagazig University

Status and phase: Completed; Phase 3; Phase 2

Conditions: Triple Intralesional Immunotherapy Combination in Multiple Recalcitrant Warts

Treatments: Biological: Intralesional antigen immunotherapy

Study type: Interventional

Funder types: Other

Identifiers

NCT05254561

IRB# 6526/-15-11-2020

Details and patient eligibility

About

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.

Full 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.

Enrollment: 160 patients

Sex: All

Ages: 10 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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160 participants in 4 patient groups

purified protein derivative (PPD)

Active Comparator group

Description:

Group A

Treatment:

Biological: Intralesional antigen immunotherapy

Candida antigen.

Active Comparator group

Description:

Group B

Treatment:

Biological: Intralesional antigen immunotherapy

Measles, Mumps and Rubella vaccine (MMR).

Active Comparator group

Description:

Group C

Treatment:

Biological: Intralesional antigen immunotherapy

Triple combination of PPD, Candida antigen and MMR

Active Comparator group

Description:

Group D

Treatment:

Biological: Intralesional antigen immunotherapy