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OpenTrials
Completed

NCT Number: NCT07329907

Combination Therapy for Warts: Candida Antigen vs. Topical Keratolytic

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.

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Key information

Conditions

Warts DNA Virus Infections Human Papilloma Virus (HPV) Infections Papillomavirus Infections Skin Diseases Skin Diseases, Infectious Skin Diseases, Viral Skin and Connective Tissue Diseases Tumor Virus Infections Virus Diseases

Age range

5 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Outpatient Clinic of Dermatology, Venereology and Andrology Department at Benha University Hospitals

Banhā, Qalyubia Governorate, 13518, Egypt

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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).

Treatment and study plan

Salicylic Acid/Lactic Acid Topical Solution

Drug

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

Candida Antigen Intralesional Injection

Biological

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

Candida Antigen and Salicylic Acid/Lactic Acid

Combination Product

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.

Primary outcomes

  1. Complete Response (CR) Rate

    Time frame: 3 months post-treatment

    Percentage of patients achieving complete disappearance of all warts.

Secondary outcomes

  1. Distant Wart Clearance Rate

    Time frame: 3 months post-treatment

    Percentage of patients achieving clearance of non-injected/distant warts.

  2. Recurrence Rate

    Time frame: 6 months post-treatment

    Percentage of patients with recurrence of warts after achieving CR.

  3. 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.

Sponsors and collaborators

Lead sponsor

Benha University

Other

Registry information

Official study title

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

Acronym: CA-SA/LA

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Jan 9, 2026
Registry last updated
Jan 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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