Triple Antigen vs Monoantigen Immunotherapy for Warts

NCT ID: NCT05254561

Last Updated: 2022-02-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

160 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-11-20

Study Completion Date

2021-11-15

Brief Summary

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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

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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.

Conditions

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Triple Intralesional Immunotherapy Combination in Multiple Recalcitrant Warts

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Parallel assignment
Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators
Double masking

Study Groups

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purified protein derivative (PPD)

Group A

Group Type ACTIVE_COMPARATOR

Intralesional antigen immunotherapy

Intervention Type BIOLOGICAL

Randomized double-blinded comparative effectiveness and safety clinical trial

Candida antigen.

Group B

Group Type ACTIVE_COMPARATOR

Intralesional antigen immunotherapy

Intervention Type BIOLOGICAL

Randomized double-blinded comparative effectiveness and safety clinical trial

Measles, Mumps and Rubella vaccine (MMR).

Group C

Group Type ACTIVE_COMPARATOR

Intralesional antigen immunotherapy

Intervention Type BIOLOGICAL

Randomized double-blinded comparative effectiveness and safety clinical trial

Triple combination of PPD, Candida antigen and MMR

Group D

Group Type ACTIVE_COMPARATOR

Intralesional antigen immunotherapy

Intervention Type BIOLOGICAL

Randomized double-blinded comparative effectiveness and safety clinical trial

Interventions

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Intralesional antigen immunotherapy

Randomized double-blinded comparative effectiveness and safety clinical trial

Intervention Type BIOLOGICAL

Other Intervention Names

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PPD, Candida antigen, and MMR

Eligibility Criteria

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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.
Minimum Eligible Age

10 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Zagazig University

OTHER_GOV

Sponsor Role lead

Responsible Party

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Basma Magdy Elkholy, MD

Dr

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Zagazig university

Zagazig, Sharqia Province, Egypt

Site Status

Countries

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Egypt

Other Identifiers

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IRB# 6526/-15-11-2020

Identifier Type: -

Identifier Source: org_study_id

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