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Completed

NCT Number: NCT05254561

Triple Antigen vs Monoantigen Immunotherapy for Warts

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.

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Key information

Conditions

Triple Intralesional Immunotherapy Combination in Multiple Recalcitrant Warts DNA Virus Infections Infections Papillomavirus Infections Skin Diseases Skin Diseases, Infectious Skin Diseases, Viral Skin and Connective Tissue Diseases Tumor Virus Infections Virus Diseases Warts

Age range

10 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Zagazig university

Zagazig, Sharqia Province, 44519, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

  • Patients with acute febrile illness or past history of asthma.
  • Allergic skin disorders such as generalized eczema and urticaria.
  • Past history of meningitis or convulsions.
  • Pregnancy or lactation.

Treatment and study plan

Intralesional antigen immunotherapy

Biological

Randomized double-blinded comparative effectiveness and safety clinical trial

Other names: PPD, Candida antigen, and MMR

Primary outcomes

  1. 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)

  2. Immediate adverse effects

    Time frame: during and till 20 minutes after intralesional injection immunotherapy

Secondary outcomes

  1. Distant wart clearance

    Time frame: within 12 weeks of starting sessions

  2. Time to complete clearance

    Time frame: within 12 weeks of starting therapy

  3. late adverse effects

    Time frame: after each session and till the end of sessions and 6 months-follow-up period

  4. Recurrence

    Time frame: For 6 months after complete response

Sponsors and collaborators

Lead sponsor

Zagazig University

Other Gov

Registry information

Official study title

Triple Intralesional Antigen Immunotherapy Versus Monoantigen in the Treatment of Multiple Recalcitrant Warts

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Feb 24, 2022
Registry last updated
Feb 24, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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