Sclerotherapy and Candida Antigen in Treatment of Common Warts

Not Applicable

Not yet recruiting

• Conditions: Common Wart
• Interventions: Drug: polidacanol 3%; Biological: candida antigen

• Registration Number: NCT06749665
• Lead Sponsor: Sohag University

Brief Summary

This study aims to evaluate the efficacy and safety of intralesional injections of candida antigen, polidocanol sclerotherapy and combined candida antigen with polidocanol in treatment of patients with common warts.

Detailed Description

Warts are benign proliferations of skin and mucosa caused by the human papillomavirus . Currently, more than 100 types of human papillomavirus have been identified, which is a non-enveloped double-stranded, circular, supercoiled DNA virus enclosed in an icosahedral capsid and comprising 72capsomers Immunotherapy in wart treatment is a type of biological therapy that uses substances to stimulate the immune system to help the body fight infected cells. This includes topical agents as imiquimod, sineacatechins, and Intralesional immunotherapy which become more preferred treatment line for several types of warts, several injectable agents have been examined such as vitamin D3, interferon alpha 2B and skin test antigens such as the candida antigen and purified protein derivatives or systemic immunotherapy as zinc, cimetidine.

Intralesional candida antigen has been successfully used in the treatment of warts with the potential advantages of promising efficacy, low cost, high safety profile, simple easy injection, association with distant response, absence of scarring and pigmentary changes and less pain than destructive therapies, and low or absent recurrence rates Treatments targeting and obliterating blood vessels such as pulsed dye laser and photodynamic therapy have been used in the treatment of common warts. Based on these observations, and the previous reports of the successful use of polidocanol in the treatment of various skin conditions with vascular components, the intralesional polidocanol therapy could be helpful in the treatment of common warts through the thrombotic occlusion and obliteration of blood vessels within the wart.

The complete and partial cure rates after intralesional polidocanol 3% injection in plantar warts were 60% and 25%, respectively

Study Timeline

• Status Verified: 2024-12
• Study First Submitted: 2024-12-19
• Study Start: 2024-12-20
• Study First Submitted QC: 2024-12-24
• Last Update Submitted: 2024-12-24
• Study First Posted: 2024-12-27
• Last Update Posted: 2024-12-27
• Primary Completion: 2025-10-01
• Study Completion: 2025-12-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 75

Inclusion Criteria

• Age group: >18years.
• Confirmed diagnosis by clinical and dermoscopic examination of common wart will be made.

Exclusion Criteria

• Patients who receive any treatment for wart in the last month before the study.
• Patients with history of renal or liver disease.
• Patients with any evidence of bleeding diathesis, vaso-occulusive or thrombo-embolic disorders.
• Pregnant and lactating females.
• Patients who receive immunosuppressive therapy.
• Patients' refusal.
• Patients with history or evidenced hypersensitivity to any component used in this study.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Polidacanol	polidacanol 3%	will receive intralesional injection of (polidacanol 3% (Aethoxysklerol 3%,60mg/ ml ampoule, kreussler pharma, Germany) During the study, the dosage of the drug and frequency of treatment will be uniform in all patients. The base of each wart will inject until the lesion blanch using an insulin syringe (29 Gage × 0.5-in) every 2 weeks until the resolution of warts or for a maximum of 6 sessions.
Candida	candida antigen	will receive intralesional injection of candida antigen at a dose of 0.2 ml. Each treatment will inject into the largest wart using an insulin syringe (29 Gage × 0.5-in) every 2 weeks until complete clearance of warts or for a maximum of 6 treatment sessions.
Polidacanol and candida	polidacanol 3%	will receive intralesional candida antigen injection in the largest wart and intralesional injection of (polidacanol 3%) in all warts using an insulin syringe (29 Gage × 0.5-in) every 2 weeks until complete clearance of warts or for a maximum of 6 treatment sessions
Polidacanol and candida	candida antigen	will receive intralesional candida antigen injection in the largest wart and intralesional injection of (polidacanol 3%) in all warts using an insulin syringe (29 Gage × 0.5-in) every 2 weeks until complete clearance of warts or for a maximum of 6 treatment sessions

Primary Outcome Measures

Name	Time	Method
size of warts	session every 2 weeks until complete clearance of warts or for a maximum of 6 treatment sessions and one month after last session	measured by ruler) with photographic comparison at base line and before each session and one month after last session in relation to baseline lesion to detect response to therapy

Trial Locations

Locations (1)

Sohag university hospital; 🇪🇬 Sohag, Egypt