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

Human Papilloma Virus Clinical Trial

Official title:

Candida Antigen and Bivalent HPV Vaccine in the Treatment of Multiple Warts: Monotherapy Versus Combined Therapy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05291845
• Other study ID #: C.ag-vs-B.HPV.V
• Status: Recruiting
• Phase: Phase 2
• Start date: April 3, 2022
• Est. completion date: October 2023

Study information

• Verified date: July 2022
• Source: Zagazig University
• Contact: Reham Essam, MD
• Phone: +201097709477
• Email: rereessam22[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 75
• Est. completion date: October 2023
• Est. primary completion date: October 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 9 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Human Papilloma Virus
• Papilloma
• Warts

Intervention

Biological:
• Candida antigen vaccine
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
• Bivalent HPV vaccine
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

Locations

Country	Name	City	State
Egypt	Reham Essam	Zagazig	Al Sharqia

Sponsors (1)

Lead Sponsor	Collaborator
Zagazig University

Country where clinical trial is conducted

Egypt, 

References & Publications (2)

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. 2021 Aug 28. pii: S0190-9622( — View 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 J — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	complete response	if there is disappearance of warts and return of the normal skin markings	upto 3 months
Primary	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)	upto 3 months
Primary	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)	upto 3 months
Secondary	recurrence rate after recovery	appearance of new lesions or recurrence of previous one	follow up for 6 months after recovery

External Links

•   Comparative efficacy of intralesional Candida antigen, intralesional bivalent human papilloma virus vaccine, and cryotherapy in the treatment of common warts
•   Intralesional versus intramuscular bivalent human papillomavirus vaccine in the treatment of recalcitrant common warts