NCT07329907

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
126

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Dec 2023

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2023

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2024

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2024

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

December 29, 2025

Completed
11 days until next milestone

First Posted

Study publicly available on registry

January 9, 2026

Completed
Last Updated

January 9, 2026

Status Verified

December 1, 2025

Enrollment Period

6 months

First QC Date

December 29, 2025

Last Update Submit

December 29, 2025

Conditions

WartsHuman Papilloma Virus (HPV)

Keywords

wartsverrucacandida antigenintralesional immunotherapysalicylic acidlactic acid

Outcome Measures

Primary Outcomes (1)

  • Complete Response (CR) Rate

    Percentage of patients achieving complete disappearance of all warts.

    3 months post-treatment

Secondary Outcomes (3)

  • Distant Wart Clearance Rate

    3 months post-treatment

  • Recurrence Rate

    6 months post-treatment

  • Safety and Tolerability Profile

    At each visit (every 2 weeks) and 3 months post-treatment

Study Arms (3)

topical monotherapy

ACTIVE COMPARATOR

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

Intralesional Monotherapy

ACTIVE COMPARATOR

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

Combination Therapy

ACTIVE COMPARATOR

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

Interventions

Salicylic Acid/Lactic Acid Topical SolutionDRUG

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

topical monotherapy
Candida Antigen Intralesional InjectionBIOLOGICAL

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

Intralesional Monotherapy
Candida Antigen and Salicylic Acid/Lactic AcidCOMBINATION_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.

Combination Therapy

Eligibility Criteria

Age5 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Banhā, Qalyubia Governorate, 13518, Egypt

Location

MeSH Terms

Conditions

Warts

Interventions

lactic acid, salicylic acid drug combination

Condition Hierarchy (Ancestors)

Papillomavirus InfectionsDNA Virus InfectionsVirus DiseasesInfectionsSkin Diseases, ViralTumor Virus InfectionsSkin Diseases, InfectiousSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Ghada Shams

    Benha University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Assessor-Blinded (Outcome Assessor Only)
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

December 29, 2025

First Posted

January 9, 2026

Study Start

December 1, 2023

Primary Completion

June 1, 2024

Study Completion

December 30, 2024

Last Updated

January 9, 2026

Record last verified: 2025-12

Locations

EG(1)