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Combination Therapy for Warts: Candida Antigen vs. Topical Keratolytic

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

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07329907
Acronym
CA-SA/LA
Enrollment
126
Registered
2026-01-09
Start date
2023-12-01
Completion date
2024-12-30
Last updated
2026-08-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Human Papilloma Virus (HPV), Warts

Keywords

warts, verruca, candida antigen, intralesional immunotherapy, salicylic acid, lactic acid

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.

Interventions

DRUGSalicylic Acid/Lactic Acid Topical Solution

Patients receive topical application of Salicylic Acid 40% and Lactic Acid 16% once daily for up to 6 weeks.

BIOLOGICALCandida Antigen Intralesional Injection

Patients receive intralesional injection of Candida Antigen (0.1-0.3 mL) every 2 weeks for up to 6 sessions.

COMBINATION_PRODUCTCandida Antigen and Salicylic Acid/Lactic Acid

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.

Sponsors

Benha University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Masking description

Assessor-Blinded (Outcome Assessor Only)

Eligibility

Sex/Gender
ALL
Age
5 Years to 60 Years
Healthy volunteers
No

Inclusion criteria

1. Single or multiple warts. 2. Aged 5 to 60 years. 3. Eligible for both topical and intralesional treatments. 4. No prior wart treatment for at least 1 month.

Exclusion criteria

1. Pregnancy or lactation. 2. Immunosuppression or use of immunosuppressive drugs. 3. Known sensitivity to study ingredients. 4. Systemic/local inflammation or infection. 5. History of bleeding/clotting disorder, or use of anticoagulants/NSAIDs. 6. History of asthma, allergic skin disorders, or convulsions. 7. History of chronic systemic diseases (renal/hepatic failure, cardiovascular disorders).

Design outcomes

Primary

MeasureTime frameDescription
Complete Response (CR) Rate3 months post-treatmentPercentage of patients achieving complete disappearance of all warts.

Secondary

MeasureTime frameDescription
Distant Wart Clearance Rate3 months post-treatmentPercentage of patients achieving clearance of non-injected/distant warts.
Recurrence Rate6 months post-treatmentPercentage of patients with recurrence of warts after achieving CR.
Safety and Tolerability ProfileAt each visit (every 2 weeks) and 3 months post-treatmentIncidence and severity of local (pain, edema, crustations) and systemic (flu-like symptoms) side effects.

Countries

Egypt

Contacts

PRINCIPAL_INVESTIGATORGhada Shams

Benha University

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 5, 2026