Combination Therapy for Warts: Candida Antigen vs. Topical Keratolytic
CA-SA/LA
Comparative Efficacy of Topical Salicylic Acid/Lactic Acid, Intralesional Candida Antigen, and Their Combination in the Treatment of Warts: A Randomized, Assessor-Blinded, Controlled Trial
1 other identifier
interventional
126
1 country
1
Brief Summary
Objective: To compare the efficacy, safety, and recurrence rates of topical salicylic acid/lactic acid (SA/LA) monotherapy (Group A), intralesional Candida antigen (CA) monotherapy (Group B), and their combination (Group C) for the treatment of warts.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Dec 2023
Shorter than P25 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
December 30, 2024
CompletedFirst Submitted
Initial submission to the registry
December 29, 2025
CompletedFirst Posted
Study publicly available on registry
January 9, 2026
CompletedAugust 4, 2026
August 1, 2026
6 months
December 29, 2025
August 1, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Complete Response (CR) Rate
Percentage of patients achieving complete disappearance of all warts.
3 months post-treatment
Secondary Outcomes (3)
Distant Wart Clearance Rate
3 months post-treatment
Recurrence Rate
6 months post-treatment
Safety and Tolerability Profile
At each visit (every 2 weeks) and 3 months post-treatment
Study Arms (3)
topical monotherapy
ACTIVE COMPARATORPatients receive topical application of Salicylic Acid 40% and Lactic Acid 16% once daily for up to 6 weeks.
Intralesional Monotherapy
ACTIVE COMPARATORPatients receive intralesional injection of Candida Antigen (0.1-0.3 mL) every 2 weeks for up to 6 sessions.
Combination Therapy
ACTIVE COMPARATORPatients receive intralesional injection of Candida Antigen (0.1-0.3 mL) every 2 weeks for up to 6 sessions, with topical Salicylic Acid 40% and Lactic Acid 16% applied in between.
Interventions
Patients receive topical application of Salicylic Acid 40% and Lactic Acid 16% once daily for up to 6 weeks.
Patients receive intralesional injection of Candida Antigen (0.1-0.3 mL) every 2 weeks for up to 6 sessions, with topical Salicylic Acid 40% and Lactic Acid 16% applied in between.
Patients receive intralesional injection of Candida Antigen (0.1-0.3 mL) every 2 weeks for up to 6 sessions.
Eligibility Criteria
You may qualify if:
- Single or multiple warts.
- Aged 5 to 60 years.
- Eligible for both topical and intralesional treatments.
- No prior wart treatment for at least 1 month.
You may not qualify if:
- Pregnancy or lactation.
- Immunosuppression or use of immunosuppressive drugs.
- Known sensitivity to study ingredients.
- Systemic/local inflammation or infection.
- History of bleeding/clotting disorder, or use of anticoagulants/NSAIDs.
- History of asthma, allergic skin disorders, or convulsions.
- History of chronic systemic diseases (renal/hepatic failure, cardiovascular disorders).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Benha Universitylead
Study Sites (1)
Outpatient Clinic of Dermatology, Venereology and Andrology Department at Benha University Hospitals
Banhā, Qalyubia Governorate, 13518, Egypt
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ghada Shams
Benha University
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Masking Details
- Assessor-Blinded (Outcome Assessor Only)
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal investigator
Study Record Dates
First Submitted
December 29, 2025
First Posted
January 9, 2026
Study Start
December 1, 2023
Primary Completion
June 1, 2024
Study Completion
December 30, 2024
Last Updated
August 4, 2026
Record last verified: 2026-08
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
- Time Frame
- Data will be available beginning 6 months and ending 36 months following the official publication of the study results.
What IPD will be shared? De-identified individual participant data that underlie the results reported in the final study, including demographic characteristics and ocular surface/meibomian gland assessment parameters. Supporting Documents: The study protocol and statistical analysis plan will be made available. When will data be available? Data will be available beginning 6 months and ending 36 months following the official publication of the study results. With whom? Data will be shared with qualified researchers who provide a methodologically sound proposal that is approved by the study investigators. For what types of analyses? To achieve the specific aims outlined in the approved research proposal. By what mechanism will data be made available? Interested researchers should contact the corresponding author via email to submit a formal request and a data use agreement.