Triple Antigen vs Monoantigen Immunotherapy for Warts

February 14, 2022 updated by: Basma Magdy Elkholy, MD, Zagazig University

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

160

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
    • Sharkia
      • Zagazig, Sharkia, Egypt, 44519
        • Zagazig University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

10 years to 70 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: purified protein derivative (PPD)
Group A
Biological: Intralesional antigen immunotherapy
Randomized double-blinded comparative effectiveness and safety clinical trial
Other Names:
  • PPD, Candida antigen, and MMR
Active Comparator: Candida antigen.
Group B
Biological: Intralesional antigen immunotherapy
Randomized double-blinded comparative effectiveness and safety clinical trial
Other Names:
  • PPD, Candida antigen, and MMR
Active Comparator: Measles, Mumps and Rubella vaccine (MMR).
Group C
Biological: Intralesional antigen immunotherapy
Randomized double-blinded comparative effectiveness and safety clinical trial
Other Names:
  • PPD, Candida antigen, and MMR
Active Comparator: Triple combination of PPD, Candida antigen and MMR
Group D
Biological: Intralesional antigen immunotherapy
Randomized double-blinded comparative effectiveness and safety clinical trial
Other Names:
  • PPD, Candida antigen, and MMR

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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)
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
during and till 20 minutes after intralesional injection immunotherapy

Secondary Outcome Measures

Outcome Measure
Time Frame
Distant wart clearance
Time Frame: within 12 weeks of starting sessions
within 12 weeks of starting sessions
Time to complete clearance
Time Frame: within 12 weeks of starting therapy
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
after each session and till the end of sessions and 6 months-follow-up period
Recurrence
Time Frame: For 6 months after complete response
For 6 months after complete response

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Zagazig University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 20, 2020

Primary Completion (Actual)

June 20, 2021

Study Completion (Actual)

November 15, 2021

Study Registration Dates

First Submitted

February 14, 2022

First Submitted That Met QC Criteria

February 14, 2022

First Posted (Actual)

February 24, 2022

Study Record Updates

Last Update Posted (Actual)

February 24, 2022

Last Update Submitted That Met QC Criteria

February 14, 2022

Last Verified

February 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB# 6526/-15-11-2020

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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