Triple Antigen vs Monoantigen Immunotherapy for Warts

Phase 2

Completed

• Conditions: Triple Intralesional Immunotherapy Combination in Multiple Recalcitrant Warts
• Interventions: Biological: Intralesional antigen immunotherapy

• Registration Number: NCT05254561
• Lead Sponsor: Zagazig University

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.

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 Timeline

• Study Start: 2020-11-20
• Primary Completion: 2021-06-20
• Study Completion: 2021-11-15
• Status Verified: 2022-02
• Study First Submitted: 2022-02-14
• Study First Submitted QC: 2022-02-14
• Last Update Submitted: 2022-02-14
• Study First Posted: 2022-02-24
• Last Update Posted: 2022-02-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 160

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Triple combination of PPD, Candida antigen and MMR	Intralesional antigen immunotherapy	Group D
Measles, Mumps and Rubella vaccine (MMR).	Intralesional antigen immunotherapy	Group C
Candida antigen.	Intralesional antigen immunotherapy	Group B
purified protein derivative (PPD)	Intralesional antigen immunotherapy	Group A

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Time to complete clearance	within 12 weeks of starting therapy
Distant wart clearance	within 12 weeks of starting sessions
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

Trial Locations

Locations (1)

Zagazig university; 🇪🇬 Zagazig, Sharkia, Egypt