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

• Sponsor: Zagazig University (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05291845
• Collaborator: (none)
• Enrollment: 75
• Location: 1
• Arms: 3
• Anticipated Duration (Months): 17.9
• Patients Per Site Per Month: 4.2

Study Details

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

Condition or Disease	Intervention/Treatment	Phase
Warts; Human Papilloma Virus	Biological: Candida antigen vaccine; Biological: Bivalent HPV vaccine	Phase 2

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

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 75 participants
• Allocation: Randomized
• Intervention Model: Factorial Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Candida Antigen and Bivalent HPV Vaccine in the Treatment of Multiple Warts: Monotherapy Versus Combined Therapy
• Actual Study Start Date: Apr 3, 2022
• Anticipated Primary Completion Date: Oct 1, 2023
• Anticipated Study Completion Date: Oct 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Candida antigen group 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.	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
Experimental: Bivalent HPV vaccine 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.	Biological: 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
Experimental: both agents group 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.	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; Biological: 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

Outcome Measures

Primary Outcome Measures

1. complete response [upto 3 months]

   if there is disappearance of warts and return of the normal skin markings

2. partial response [upto 3 months]

   if warts regressed in size by 50-99% (the size will be measured as the summation of size of all lesions in cm)

3. no response [upto 3 months]

   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

1. recurrence rate after recovery [follow up for 6 months after recovery]

   appearance of new lesions or recurrence of previous one

Eligibility Criteria

Criteria

• Ages Eligible for Study: 9 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Reham Essam	Zagazig	Al Sharqia	Egypt	2543

Sponsors and Collaborators

• Zagazig University

Investigators

• Principal Investigator: Reham Essam, MD, Zagazig University
• Study Director: Ahmad Nofal, MD, Zagazig University

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

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

Publications

None provided.

• Responsible Party: Reham Essam, Lecturer of Dermatology, Zagazig University
• ClinicalTrials.gov Identifier: NCT05291845
• Other Study ID Numbers: C.ag-vs-B.HPV.V
• First Posted: Mar 23, 2022
• Last Update Posted: Jul 29, 2022
• Last Verified: Jul 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Warts; Papilloma; Vaccines

Study Results

No Results Posted as of Jul 29, 2022