Combination Therapy for Warts: Candida Antigen vs. Topical Keratolytic (CA-SA/LA)

December 29, 2025 updated by: Ghada Mohamed Shams, Benha University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

126

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
    • Qalyubia Governorate
      • Banhā, Qalyubia Governorate, Egypt, 13518
        • Outpatient Clinic of Dermatology, Venereology and Andrology Department at Benha University Hospitals

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

No

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: topical monotherapy
Patients receive topical application of Salicylic Acid 40% and Lactic Acid 16% once daily for up to 6 weeks.
Drug: Salicylic Acid/Lactic Acid Topical Solution
Patients receive topical application of Salicylic Acid 40% and Lactic Acid 16% once daily for up to 6 weeks.
Active Comparator: Intralesional Monotherapy
Patients receive intralesional injection of Candida Antigen (0.1-0.3 mL) every 2 weeks for up to 6 sessions.
Biological: Candida Antigen Intralesional Injection
Patients receive intralesional injection of Candida Antigen (0.1-0.3 mL) every 2 weeks for up to 6 sessions.
Active Comparator: Combination Therapy
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.
Combination product: Candida 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Complete Response (CR) Rate
Time Frame: 3 months post-treatment
Percentage of patients achieving complete disappearance of all warts.
3 months post-treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Distant Wart Clearance Rate
Time Frame: 3 months post-treatment
Percentage of patients achieving clearance of non-injected/distant warts.
3 months post-treatment
Recurrence Rate
Time Frame: 6 months post-treatment
Percentage of patients with recurrence of warts after achieving CR.
6 months post-treatment
Safety and Tolerability Profile
Time Frame: At each visit (every 2 weeks) and 3 months post-treatment
Incidence and severity of local (pain, edema, crustations) and systemic (flu-like symptoms) side effects.
At each visit (every 2 weeks) and 3 months post-treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Benha University

Investigators

  • Principal Investigator: Ghada Shams, Benha University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2023

Primary Completion (Actual)

June 1, 2024

Study Completion (Actual)

December 30, 2024

Study Registration Dates

First Submitted

December 29, 2025

First Submitted That Met QC Criteria

December 29, 2025

First Posted (Actual)

January 9, 2026

Study Record Updates

Last Update Posted (Actual)

January 9, 2026

Last Update Submitted That Met QC Criteria

December 29, 2025

Last Verified

December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Combination therapy for warts

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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