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NCT04399577 Clinical Trial

Complement Component 3c and Tumor Necrosis Factor-α in Patients With Human Papillomavirus-Induced Cutaneous Warts

Warts Clinical Trial

Official title:
Complement Component 3c and Tumor Necrosis Factor-α in Patients With Human Papillomavirus-Induced Cutaneous Warts

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04399577
Other study ID # 3140/23-10-2016
Secondary ID
Status Completed
Phase Phase 2
First received
Last updated
Start date July 1, 2017
Est. completion date September 3, 2019

Study information
Verified date May 2020
Source Zagazig University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The investigators explore the role of the complement pathway and T helper 1 immune response in clinical response to Candida immunotherapy via complement component and tumor necrosis factor, respectively.

Description:

39 patients are enrolled in the study They suffer from chronic recurrent cutaneous warts Patients receive Candida antigen immunotherapy vial intra-lesional injection every 2 weeks till complete resolution or the maximum of 5 sessions Blood samples are withdrawn before and after intervention C3, C4, MBL, C3C and TNF alpha serum levels are measured

Recruitment information / eligibility
Status Completed
Enrollment 39
Est. completion date September 3, 2019
Est. primary completion date March 3, 2019
Accepts healthy volunteers No
Gender All
Age group 9 Years to 45 Years
Eligibility Inclusion Criteria:

- Chronic multiple cutaneous

Exclusion Criteria:

- Hypersensitivity to Candida antigen

- Fever

- Immunosuppressive disorders

- Previous wart therapy in the last month

Study Design

Related Conditions & MeSH terms

Intervention

Biological:
• Candida antigen
Patient receive candida antigen immunotherapy and blood samples will be withdrawn before and after intervention

Locations
Country Name City State
Egypt Zagazig University Faculty of Medicine Zagazig Sharqia

Sponsors (1)
Lead Sponsor Collaborator
Zagazig University

Country where clinical trial is conducted

Egypt, 

Outcome
Type Measure Description Time frame Safety issue
Primary Resolution of warts 100% clearance of warts 12 weeks
Secondary Recurrence Reappearance of warts 6 months
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