Sclerotherapy and Candida Antigen in Treatment of Common Warts

NCT06749665 | Not Yet Recruiting

• 1 other identifier: HShawkyosman
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

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.

Conditions

Common Wart

Outcome Measures

Primary Outcomes (1)

• size of warts

  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

  session every 2 weeks until complete clearance of warts or for a maximum of 6 treatment sessions and one month after last session

Study Arms (3)

Polidacanol

ACTIVE COMPARATOR

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.

Drug: polidacanol 3%

Candida

ACTIVE COMPARATOR

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.

Biological: candida antigen

Polidacanol and candida

ACTIVE COMPARATOR

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

Drug: polidacanol 3%; Biological: candida antigen

Interventions

polidacanol 3% DRUG

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

Polidacanol; Polidacanol and candida

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

Candida; Polidacanol and candida

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sohag University: lead

Study Sites (1)

Sohag university hospital

Sohag, Egypt

Location

Related Publications (4)

• 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/

  PMID: 28846281 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

MeSH Terms

Conditions

Warts

Interventions

PRA1 protein, Candida albicans

Condition Hierarchy (Ancestors)

Papillomavirus Infections; DNA Virus Infections; Virus Diseases; Infections; Skin Diseases, Viral; Tumor Virus Infections; Skin Diseases, Infectious; Skin Diseases; Skin and Connective Tissue Diseases

Central Study Contacts

Heba S Osman

CONTACT

01013846228; heba_shawky_post@med.sohag.edu.eg

Mohamed A Ali

CONTACT

01004139060

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident at Dermatology, Venereology, and Andrology Department Sohag University Hospital

Study Record Dates

• First Submitted: December 19, 2024
• First Posted: December 27, 2024
• Study Start: December 20, 2024
• Primary Completion: October 1, 2025
• Study Completion: December 1, 2025
• Last Updated: December 27, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)