Triple Antigen vs Monoantigen Immunotherapy for Warts

Sponsor

Zagazig University (Other)

Overall Status

Completed

CT.gov ID

NCT05254561

Collaborator

(none)

160

Enrollment

Location

Arms

11.8

Actual Duration (Months)

13.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Triple Intralesional Immunotherapy Combination in Multiple Recalcitrant Warts	Biological: Intralesional antigen immunotherapy	Phase 2/Phase 3

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 Design

Study Type:

Interventional

Actual Enrollment :

160 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Parallel assignmentParallel assignment

Masking:

Double (Participant, Investigator)

Masking Description:

Double masking

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Nov 20, 2020

Actual Primary Completion Date :

Jun 20, 2021

Actual Study Completion Date :

Nov 15, 2021

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

Overall complete response of both treated and distant warts [within 12 weeks of starting treatment sessions (up to 1 month after the last session, maximum 5 sessions)]
Immediate adverse effects [during and till 20 minutes after intralesional injection immunotherapy]

Secondary Outcome Measures

Distant wart clearance [within 12 weeks of starting sessions]
Time to complete clearance [within 12 weeks of starting therapy]
late adverse effects [after each session and till the end of sessions and 6 months-follow-up period]
Recurrence [For 6 months after complete response]

Eligibility Criteria

Criteria

Ages Eligible for Study:

10 Years to 70 Years

Sexes Eligible for Study:

All

Accepts 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