Common WartNCT06749665
Sclerotherapy and Candida Antigen in Treatment of Common Warts
A study testing polidacanol 3% and candida antigen in people with Common Wart, run by Sohag University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Common Wart
- What is being tested?
- polidacanol 3% and candida antigen
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteEgypt
- Study dates
- 20 Dec 2024to 1 Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age group: >18years.
- Confirmed diagnosis by clinical and dermoscopic examination of common wart will be made.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Mohamed A Ali contact
About this study
Official 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
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.
Read the detailed description
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
- Common Wart
- Being tested
- polidacanol 3%, candida antigen
- Medical subject headings
- Warts
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
polidacanol 3%Drug
Aethoxysklerol 3%,60mg/ ml ampoule, kreussler pharma, Germany
candida antigenBiological
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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 Receives: Drug: polidacanol 3%; Biological: candida antigen |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: session every 2 weeks until complete clearance of warts or for a maximum of 6 treatment sessions and one month after last session
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Dec 2024
- Study start20 Dec 2024 (estimated)
- Primary completion1 Oct 2025 (estimated)
- Study completion1 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Common WartStudies of the same condition, open and under way.
- More trials run by Sohag UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Heba Shawky Osman, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06749665
- Sponsor's protocol ID
- HShawkyosman
- Status last verified
- Dec 2024
- First submitted
- 19 Dec 2024
- Last updated
- 27 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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/
PubMed 28846281Araldi 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.
PubMed 30119229Parsi 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.
PubMed 21183368Hekmatjah 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.
PubMed 34809773
Study at a glance
From the registry record, last updated by the sponsor on 27 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT06749665
- Acronym / sponsor ID
- HShawkyosman
- Conditions
- Common Wart
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 20 Dec 2024 (estimated)
- Primary completion
- 1 Oct 2025 (estimated)
- Study completion
- 1 Dec 2025 (estimated)
- First posted
- 27 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Polidacanol | Active comparator | Drug: polidacanol 3%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. |
| Candida | Active comparator | Biological: candida antigenwill 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. |
| Polidacanol and candida | Active comparator | Drug: polidacanol 3%, Biological: candida antigenwill 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 |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Age group: >18years.
- Confirmed diagnosis by clinical and dermoscopic examination of common wart will be made.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| polidacanol 3%Aethoxysklerol 3%,60mg/ ml ampoule, kreussler pharma, Germany | Drug | Polidacanol, Polidacanol and candida |
| candida antigendelayed 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 | Biological | Candida, Polidacanol and candida |
Primary outcome
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Dec 2024.
- Background: PubMed 28846281Luria 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/
- Background: PubMed 30119229Araldi 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.
- Background: PubMed 21183368Parsi 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.
- Background: PubMed 34809773Hekmatjah 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Mohamed A Ali contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing polidacanol 3% and candida antigen in people with Common Wart, run by Sohag University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 27 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Heba S Osman (01013846228, heba_shawky_post@med.sohag.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06749665, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Dec 2024.