An interventional study of polidacanol 3% and candida antigen in Common Wart, sponsored by Sohag University. Not yet recruiting at 1 site in Egypt. Open to participants aged 18 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-12-27.
Sponsored by Sohag University · Not applicable, Interventional, and Treatment
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.
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
171 studies on the registry are indexed under Warts; 35 are open to participants now.
This study's planned enrollment of 75 is close to the median of 70 across 155 interventional studies indexed under Warts.
Browse Warts studies →Sohag University is the lead sponsor of 1,230 studies on the registry; 636 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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%
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
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
Aethoxysklerol 3%,60mg/ ml ampoule, kreussler pharma, Germany
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
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
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
Plan to share: No
This study is not yet recruiting, as verified in Dec 2024. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Candida albicans