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Sclerotherapy and Candida Antigen in Treatment of Common Warts

NCT ID: NCT06749665

Last Updated: 2024-12-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

75 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-12-20

Study Completion Date

2025-12-01

Brief Summary

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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

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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

Conditions

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Common Wart

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Polidacanol

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.

Group Type ACTIVE_COMPARATOR

polidacanol 3%

Intervention Type DRUG

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

Candida

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.

Group Type ACTIVE_COMPARATOR

candida antigen

Intervention Type 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

Polidacanol and candida

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

Group Type ACTIVE_COMPARATOR

polidacanol 3%

Intervention Type DRUG

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

candida antigen

Intervention Type 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

Interventions

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polidacanol 3%

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

Intervention Type DRUG

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

Intervention Type BIOLOGICAL

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Sohag University

OTHER

Sponsor Role lead

Responsible Party

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Heba Shawky Osman

Resident at Dermatology, Venereology, and Andrology Department Sohag University Hospital

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Sohag university hospital

Sohag, , Egypt

Site Status

Countries

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Egypt

Central Contacts

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Heba S Osman

Role: CONTACT

Phone: 01013846228

Email: [email protected]

Mohamed A Ali

Role: CONTACT

Phone: 01004139060

Facility Contacts

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Magdy M Amin, Professor

Role: primary

References

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Luria L, Cardoza-Favarato G. Human Papillomavirus. 2023 Jan 16. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2025 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK448132/

Reference Type BACKGROUND
PMID: 28846281 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 30119229 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 21183368 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 34809773 (View on PubMed)

Other Identifiers

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HShawkyosman

Identifier Type: -

Identifier Source: org_study_id