Combination Therapy for Warts: Candida Antigen vs. Topical Keratolytic

NCT ID: NCT07329907

Last Updated: 2026-01-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

126 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-12-01

Study Completion Date

2024-12-30

Brief Summary

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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.

Detailed Description

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Conditions

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Warts Human Papilloma Virus (HPV)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors
Assessor-Blinded (Outcome Assessor Only)

Study Groups

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topical monotherapy

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

Group Type ACTIVE_COMPARATOR

Salicylic Acid/Lactic Acid Topical Solution

Intervention Type DRUG

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

Intralesional Monotherapy

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

Group Type ACTIVE_COMPARATOR

Candida Antigen Intralesional Injection

Intervention Type BIOLOGICAL

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

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.

Group Type ACTIVE_COMPARATOR

Candida Antigen and Salicylic Acid/Lactic Acid

Intervention Type 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.

Interventions

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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.

Intervention Type DRUG

Candida Antigen Intralesional Injection

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

Intervention Type BIOLOGICAL

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.

Intervention Type COMBINATION_PRODUCT

Eligibility Criteria

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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).
Minimum Eligible Age

5 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Benha University

OTHER

Sponsor Role lead

Responsible Party

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Ghada Mohamed Shams

Principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ghada Shams

Role: PRINCIPAL_INVESTIGATOR

Benha University

Locations

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

Banhā, Qalyubia Governorate, Egypt

Site Status

Countries

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Egypt

Other Identifiers

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Combination therapy for warts

Identifier Type: -

Identifier Source: org_study_id

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