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Candida Antigen and Bivalent HPV Vaccine in the Treatment of Multiple Warts

Primary Purpose

Warts, Human Papilloma Virus

Status
Recruiting
Phase
Phase 2
Locations
Egypt
Study Type
Interventional
Intervention
Candida antigen vaccine
Bivalent HPV vaccine
Sponsored by
Zagazig University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Warts

Eligibility Criteria

9 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • patients with multiple, recalcitrant, or non-recalcitrant common warts of different sites, sizes, duration, and with or without distant lesions will be enrolled in the study

Exclusion Criteria:

  • Pregnant female. Hypersensitivity to Candida antigen or bivalent HPV vaccine

Sites / Locations

  • Reham EssamRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Candida antigen group

Bivalent HPV vaccine

both agents group

Arm Description

25 patients will be treated with Candida antigen. All patients will be directly injected with Candida antigen into the largest wart using an insulin syringe. Injections will be done at 2-week intervals until complete clearance will be achieved or for a maximum of five treatment sessions.

25 patients will be treated with the Bivalent HPV vaccine. All patients will be directly injected with the vaccine into the largest wart using an insulin syringe. Injections will be done at 2-week intervals until complete clearance will be achieved or for a maximum of five treatment sessions.

25 patients will be treated with Both agents at the same session. Injections will be done at 2-week intervals until complete clearance will be achieved or for a maximum of five treatment sessions.

Outcomes

Primary Outcome Measures

complete response
if there is disappearance of warts and return of the normal skin markings
partial response
if warts regressed in size by 50-99% (the size will be measured as the summation of size of all lesions in cm)
no response
if there is < 50% decrease in wart size. (the size will be measured as the summation of size of all lesions in cm)

Secondary Outcome Measures

recurrence rate after recovery
appearance of new lesions or recurrence of previous one

Full Information

First Posted
March 14, 2022
Last Updated
July 26, 2022
Sponsor
Zagazig University
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1. Study Identification

Unique Protocol Identification Number
NCT05291845
Brief Title
Candida Antigen and Bivalent HPV Vaccine in the Treatment of Multiple Warts
Official Title
Candida Antigen and Bivalent HPV Vaccine in the Treatment of Multiple Warts: Monotherapy Versus Combined Therapy
Study Type
Interventional

2. Study Status

Record Verification Date
July 2022
Overall Recruitment Status
Recruiting
Study Start Date
April 3, 2022 (Actual)
Primary Completion Date
October 2023 (Anticipated)
Study Completion Date
October 2023 (Anticipated)

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
Data Monitoring Committee
No

5. Study Description

Brief Summary
To follow up the efficacy and safety of Candida antigen, bivalent HPV vaccine in treatment of common warts either mono or combined intralesional therapy
Detailed Description
Group A: 25 patients will be treated with Candida antigen. All patients will be directly injected with Candida antigen into the largest wart using an insulin syringe. Injections will be done at 2-week intervals until complete clearance will be achieved or for a maximum of five treatment sessions. Group B: 25 patients will be treated with bivalent HPV vaccine solution intralesional into the largest wart using an insulin syringe. Injections will be done at 2-week intervals until complete clearance will be achieved or for a maximum of five treatment sessions. Group C: 25 patients will be treated with both agents intralesionally into the largest wart using an insulin syringe at 2-week intervals until complete clearance will be achieved or for a maximum of five treatment sessions. it is thought that candida antigen act through a cell-mediated immune response and bivalent HPV vaccine act mainly through humoral immunity, so we want to study their effect as single or mixed agents

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Warts, Human Papilloma Virus

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Factorial Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
75 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Candida antigen group
Arm Type
Experimental
Arm Description
25 patients will be treated with Candida antigen. All patients will be directly injected with Candida antigen into the largest wart using an insulin syringe. Injections will be done at 2-week intervals until complete clearance will be achieved or for a maximum of five treatment sessions.
Arm Title
Bivalent HPV vaccine
Arm Type
Experimental
Arm Description
25 patients will be treated with the Bivalent HPV vaccine. All patients will be directly injected with the vaccine into the largest wart using an insulin syringe. Injections will be done at 2-week intervals until complete clearance will be achieved or for a maximum of five treatment sessions.
Arm Title
both agents group
Arm Type
Experimental
Arm Description
25 patients will be treated with Both agents at the same session. Injections will be done at 2-week intervals until complete clearance will be achieved or for a maximum of five treatment sessions.
Intervention Type
Biological
Intervention Name(s)
Candida antigen vaccine
Intervention Description
we will study the efficacy and safety of agent in the treatment of multiple warts, we will follow up the recurrence rate of each group
Intervention Type
Biological
Intervention Name(s)
Bivalent HPV vaccine
Intervention Description
we will study the efficacy and safety of agent in the treatment of multiple warts, we will follow up the recurrence rate of each group
Primary Outcome Measure Information:
Title
complete response
Description
if there is disappearance of warts and return of the normal skin markings
Time Frame
upto 3 months
Title
partial response
Description
if warts regressed in size by 50-99% (the size will be measured as the summation of size of all lesions in cm)
Time Frame
upto 3 months
Title
no response
Description
if there is < 50% decrease in wart size. (the size will be measured as the summation of size of all lesions in cm)
Time Frame
upto 3 months
Secondary Outcome Measure Information:
Title
recurrence rate after recovery
Description
appearance of new lesions or recurrence of previous one
Time Frame
follow up for 6 months after recovery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
9 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: patients with multiple, recalcitrant, or non-recalcitrant common warts of different sites, sizes, duration, and with or without distant lesions will be enrolled in the study Exclusion Criteria: Pregnant female. Hypersensitivity to Candida antigen or bivalent HPV vaccine
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Reham Essam, MD
Phone
+201097709477
Email
rereessam22@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Reham Essam, MD
Phone
+201097709477
Email
rekfarid@medicine.zu.edu.eg
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Reham Essam, MD
Organizational Affiliation
Zagazig University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ahmad Nofal, MD
Organizational Affiliation
Zagazig University
Official's Role
Study Director
Facility Information:
Facility Name
Reham Essam
City
Zagazig
State/Province
Al Sharqia
ZIP/Postal Code
2543
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Reham Essam
Phone
01097709477
Email
rereessam22@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
31369771
Citation
Nofal A, Marei A, Ibrahim AM, Nofal E, Nabil M. Intralesional versus intramuscular bivalent human papillomavirus vaccine in the treatment of recalcitrant common warts. J Am Acad Dermatol. 2020 Jan;82(1):94-100. doi: 10.1016/j.jaad.2019.07.070. Epub 2019 Jul 29.
Results Reference
result
PubMed Identifier
34464624
Citation
Nassar A, Alakad R, Essam R, Bakr NM, Nofal A. Comparative efficacy of intralesional Candida antigen, intralesional bivalent human papilloma virus vaccine, and cryotherapy in the treatment of common warts. J Am Acad Dermatol. 2022 Aug;87(2):419-421. doi: 10.1016/j.jaad.2021.08.040. Epub 2021 Aug 28. No abstract available.
Results Reference
result
Links:
URL
https://doi.org/10.1016/j.jaad.2019.07.070
Description
Intralesional versus intramuscular bivalent human papillomavirus vaccine in the treatment of recalcitrant common warts
URL
https://doi.org/10.1016/j.jaad.2021.08.040
Description
Comparative efficacy of intralesional Candida antigen, intralesional bivalent human papilloma virus vaccine, and cryotherapy in the treatment of common warts

Learn more about this trial

Candida Antigen and Bivalent HPV Vaccine in the Treatment of Multiple Warts

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