WartsPhase 2CA-SA/LANCT07329907
Combination Therapy for Warts: Candida Antigen vs. Topical Keratolytic
A Phase 2 study testing Salicylic Acid/Lactic Acid Topical Solution, Candida Antigen Intralesional Injection and Candida Antigen and Salicylic Acid/Lactic Acid in people with Warts and Human Papilloma Virus (HPV), run by Benha University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 5 to 60 years
- Conditions the study is for
- Warts, Human Papilloma Virus (HPV)
- What is being tested?
- Salicylic Acid/Lactic Acid Topical Solution, Candida Antigen Intralesional Injection and Candida Antigen and Salicylic Acid/Lactic Acid
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 126 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Dec 2023to 30 Dec 2024
- Phase
- Phase 2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 60 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Outpatient Clinic of Dermatology, Venereology and Andrology Department at Benha University Hospitals
Banhā, Qalyubia Governorate, 13518
About this study
Official 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
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.
- Conditions
- Warts, Human Papilloma Virus (HPV)
- Being tested
- Salicylic Acid/Lactic Acid Topical Solution, Candida Antigen Intralesional Injection, Candida Antigen and Salicylic Acid/Lactic Acid
- Keywords
- warts, verruca, candida antigen, intralesional immunotherapy, salicylic acid, lactic acid
- Medical subject headings
- Warts
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
Candida Antigen Intralesional InjectionBiological
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 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.
| Study group | Role | What they receive |
|---|---|---|
| topical monotherapy | Active comparator | Patients receive topical application of Salicylic Acid 40% and Lactic Acid 16% once daily for up to 6 weeks. Receives: 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. Receives: 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. Receives: Combination Product: Candida Antigen and Salicylic Acid/Lactic Acid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete Response (CR) Rate
Percentage of patients achieving complete disappearance of all warts.
Measured: 3 months post-treatment
Secondary outcomes (3)
Distant Wart Clearance Rate
Percentage of patients achieving clearance of non-injected/distant warts.
Measured: 3 months post-treatment
Recurrence Rate
Percentage of patients with recurrence of warts after achieving CR.
Measured: 6 months post-treatment
Safety and Tolerability Profile
Incidence and severity of local (pain, edema, crustations) and systemic (flu-like symptoms) side effects.
Measured: At each visit (every 2 weeks) and 3 months post-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2026
- Study start1 Dec 2023
- Primary completion1 Jun 2024
- Study completion30 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for WartsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 126 participants (actual)
Sponsor and investigators
- Lead sponsor
- Benha University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ghada Mohamed Shams, Benha University
- Investigators
- Ghada Shams, Principal investigator, Benha University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07329907
- Sponsor's protocol ID
- Combination therapy for warts
- Acronym
- CA-SA/LA
- Status last verified
- Aug 2026
- First submitted
- 29 Dec 2025
- Last updated
- 4 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: What IPD will be shared? De-identified individual participant data that underlie the results reported in the final study, including demographic characteristics and ocular surface/meibomian gland assessment parameters. Supporting Documents: The study protocol and statistical analysis plan will be made available. When will data be available? Data will be available beginning 6 months and ending 36 months following the official publication of the study results. With whom? Data will be shared with qualified researchers who provide a methodologically sound proposal that is approved by the study investigators. For what types of analyses? To achieve the specific aims outlined in the approved research proposal. By what mechanism will data be made available? Interested researchers should contact the corresponding author via email to submit a formal request and a data use agreement.