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NCT Number: NCT06749665

Sclerotherapy and Candida Antigen in Treatment of Common Warts

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.

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Key information

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sohag university hospital

Sohag, Egypt

Location contact

Magdy M Amin, Professor

CONTACT

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

polidacanol 3%

Drug

Aethoxysklerol 3%,60mg/ ml ampoule, kreussler pharma, Germany

candida antigen

Biological

delayed type of hypersensitivity reaction is induced toward the injected antigen and the wart virus as well. This can increase the ability of the immune system to recognize and eradicate the human papillomavirus on various parts of the body and eliminate the necessity of local treatment for each wart

Primary outcomes

  1. size of warts

    Time frame: 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

Study contacts

Contact information is provided by the study sponsor or research team.

Heba S Osman

CONTACT

[email protected]

01013846228

Mohamed A Ali

CONTACT

01004139060

Sponsors and collaborators

Lead sponsor

Sohag University

Other

Registry information

Official study title

Efficacy and Safety of Intralesional Injections of Candida Antigen, Polidocanol Sclerotherapy and Combined Candida Antigen With Polidocanol in Treatment of Patients With Common Warts

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Dec 27, 2024
Registry last updated
Dec 27, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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