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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| topical monotherapy | Active Comparator | Patients receive topical application of Salicylic Acid 40% and Lactic Acid 16% once daily for up to 6 weeks. |
|
| Intralesional Monotherapy | Active Comparator | Patients receive intralesional injection of Candida Antigen (0.1-0.3 mL) every 2 weeks for up to 6 sessions. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Complete Response (CR) Rate | Percentage of patients achieving complete disappearance of all warts. | 3 months post-treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Distant Wart Clearance Rate | Percentage of patients achieving clearance of non-injected/distant warts. | 3 months post-treatment |
| Recurrence Rate | Percentage of patients with recurrence of warts after achieving CR. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ghada Shams | Benha University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Outpatient Clinic of Dermatology, Venereology and Andrology Department at Benha University Hospitals | Banhā | Qalyubia Governorate | 13518 | Egypt |
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| ID | Term |
|---|---|
| D014860 | Warts |
| ID | Term |
|---|---|
| D030361 | Papillomavirus Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
| D007239 | Infections |
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| ID | Term |
|---|---|
| C011564 | lactic acid, salicylic acid drug combination |
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Assessor-Blinded (Outcome Assessor Only)
| 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. |
|
| 6 months post-treatment |
| Safety and Tolerability Profile | Incidence and severity of local (pain, edema, crustations) and systemic (flu-like symptoms) side effects. | At each visit (every 2 weeks) and 3 months post-treatment |
| D017193 |
| Skin Diseases, Viral |
| D014412 | Tumor Virus Infections |
| D012874 | Skin Diseases, Infectious |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |