Back to resultsComplement Component 3c and Tumor Necrosis Factor-α in Patients With Human Papillomavirus-Induced Cutaneous Warts
Primary Purpose
Warts
Status
Completed
Phase
Phase 2
Locations
Egypt
Study Type
Interventional
Intervention
Candida antigen
Sponsored by
About this trial
This is an interventional other trial for Warts
Eligibility Criteria
Inclusion Criteria:
- Chronic multiple cutaneous
Exclusion Criteria:
- Hypersensitivity to Candida antigen
- Fever
- Immunosuppressive disorders
- Previous wart therapy in the last month
Sites / Locations
- Zagazig University Faculty of Medicine
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Wart Patients
Arm Description
Patient receive 0.1 mL of diluted preparation of candida solution at 2 weeks interval for the maximum of 5 sessions
Outcomes
Primary Outcome Measures
Resolution of warts
100% clearance of warts
Secondary Outcome Measures
Recurrence
Reappearance of warts
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04399577
Brief Title
Complement Component 3c and Tumor Necrosis Factor-α in Patients With Human Papillomavirus-Induced Cutaneous Warts
Official Title
Complement Component 3c and Tumor Necrosis Factor-α in Patients With Human Papillomavirus-Induced Cutaneous Warts
Study Type
Interventional
2. Study Status
Record Verification Date
May 2020
Overall Recruitment Status
Completed
Study Start Date
July 1, 2017 (Actual)
Primary Completion Date
March 3, 2019 (Actual)
Study Completion Date
September 3, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Zagazig University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief 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.
Detailed 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vial intra-lesional injection every 2 weeks till complete resolution or the maximum of 5 sessions Blood samples are withdrawn before and after intervention C3, C4, MBL, C3C and TNF alpha serum levels are measured
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Warts
7. Study Design
Primary Purpose
Other
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
39 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Wart Patients
Arm Type
Experimental
Arm Description
Patient receive 0.1 mL of diluted preparation of candida solution at 2 weeks interval for the maximum of 5 sessions
Intervention Type
Biological
Intervention Name(s)
Candida antigen
Intervention Description
Patient receive candida antigen immunotherapy and blood samples will be withdrawn before and after intervention
Primary Outcome Measure Information:
Title
Resolution of warts
Description
100% clearance of warts
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Recurrence
Description
Reappearance of warts
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
9 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Chronic multiple cutaneous
Exclusion Criteria:
Hypersensitivity to Candida antigen
Fever
Immunosuppressive disorders
Previous wart therapy in the last month
Facility Information:
Facility Name
Zagazig University Faculty of Medicine
City
Zagazig
State/Province
Sharqia
ZIP/Postal Code
44519
Country
Egypt
12. IPD Sharing Statement
Citations:
PubMed Identifier
32594377
Citation
Hammad NM, Abdelhadi AA, Fawzy MM, Marei A. Complement component 3c and tumor necrosis factor-alpha systemic assessment after Candida antigen immunotherapy in cutaneous warts. Braz J Microbiol. 2020 Dec;51(4):1673-1681. doi: 10.1007/s42770-020-00322-0. Epub 2020 Jun 27.
Results Reference
derived
Learn more about this trial
Complement Component 3c and Tumor Necrosis Factor-α in Patients With Human Papillomavirus-Induced Cutaneous Warts
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