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Набор скоро начнётся NCT06749665

Sclerotherapy and Candida Antigen in Treatment of Common Warts

Без фазы С лечением Common Wart

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: polidacanol 3%, candida antigen.
Кому может быть актуально
Состояния в реестре: Common Wart. Базовые параметры: 18 лет — 60 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Египет
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

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

Обзор

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.

Подробное описание

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

Вмешательства

  • Препарат polidacanol 3%
    Aethoxysklerol 3%,60mg/ ml ampoule, kreussler pharma, Germany
  • Биопрепарат candida antigen
    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

Первичные конечные точки

  • size of warts [Срок оценки: session every 2 weeks until complete clearance of warts or for a maximum of 6 treatment sessions and one month after last session]

Критерии участия

Критерии включения

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

Критерии исключения

  • 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Открытое
Основная цель
Лечение

Центры проведения

Египет · 1 центр
  • Sohag university hospital — Sohag

Публикации

  • Luria L, Cardoza-Favarato G. Human Papillomavirus. 2023 Jan 16. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2026 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK448132/ PMID 28846281
  • Araldi RP, Sant'Ana TA, Modolo DG, de Melo TC, Spadacci-Morena DD, de Cassia Stocco R, Cerutti JM, de Souza EB. The human papillomavirus (HPV)-related cancer biology: An overview. Biomed Pharmacother. 2018 Oct;106:1537-1556. doi: 10.1016/j.biopha.2018.06.149. Epub 2018 Jul 26. PMID 30119229
  • Parsi K, Exner T, Low J, Fung Ma DD, Joseph JE. In vitro effects of detergent sclerosants on clot formation and fibrinolysis. Eur J Vasc Endovasc Surg. 2011 Feb;41(2):267-77. doi: 10.1016/j.ejvs.2010.10.004. Epub 2010 Dec 22. PMID 21183368
  • Hekmatjah J, Farshchian M, Grant-Kels JM, Mehregan D. The status of treatment for plantar warts in 2021: No definitive advancements in decades for a common dermatology disease. Clin Dermatol. 2021 Jul-Aug;39(4):688-694. doi: 10.1016/j.clindermatol.2021.05.024. Epub 2021 May 19. PMID 34809773

Идентификаторы

NCT: NCT06749665 · HShawkyosman

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗