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

Benha University

Status and phase: Completed; Phase 2

Conditions: Human Papilloma Virus (HPV); Warts

Treatments: Biological: Candida Antigen Intralesional Injection; Combination Product: Candida Antigen and Salicylic Acid/Lactic Acid; Drug: Salicylic Acid/Lactic Acid Topical Solution

Study type: Interventional

Funder types: Other

Identifiers

NCT07329907

Combination therapy for warts

Details and patient eligibility

About

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.

Enrollment: 126 patients

Sex: All

Ages: 5 to 60 years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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126 participants in 3 patient groups

topical monotherapy

Active Comparator group

Description:

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

Treatment:

Drug: Salicylic Acid/Lactic Acid Topical Solution

Intralesional Monotherapy

Active Comparator group

Description:

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

Treatment:

Biological: Candida Antigen Intralesional Injection

Combination Therapy

Active Comparator group

Description:

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.

Treatment:

Combination Product: Candida Antigen and Salicylic Acid/Lactic Acid