Eye InfectionsPhase 2NCT06720467
Immunotherapy in Eyelid Viral Papilloma
A Phase 2 study testing Intralesional injection of Candida albicans 1:20 w/v 10 ml vial (Allergy Laboratories, INC. Oklahoma City, USA.) in people with Eye Infections, run by Zagazig University at 1 site in Egypt.
Trial summary
intralesional injection of Candida antigens for treating eyelid warts is supposed to have less destructive effect than other surgical interventions Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Eye Infections
- What is being tested?
- Intralesional injection of Candida albicans 1:20 w/v 10 ml vial (Allergy Laboratories, INC. Oklahoma City, USA.)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteEgypt
- Study dates
- 11 Jun 2024to 15 Jun 2025
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- patients with cutaneous eyelid viral warts whether single or multiple, with no concurrent systemic or topical treatment for warts. Patients aged more than 12 years, with sensitivity test, showed induration less than or equal to five mm. and patients can understand and comply with the requirements of the trials.
Who cannot join
- pregnancy, breastfeeding, patients with immunodeficiency; like diabetics. In addition, patients with a history of hypersensitivity to any used component in this trial, asthma, or allergic skin diseases. Moreover, patients on any treatment modality for warts at least 1 month before the start of the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Role of Immunotherapy in the Treatment of Eyelid Viral Papilloma
intralesional injection of Candida antigens for treating eyelid warts is supposed to have less destructive effect than other surgical interventions
Read the detailed description
Despite many surgical and interventional modalities of treating ocular warts, all have a destructive nature for this delicate tissue with a high recurrence rate. intralesional injection of Candida antigens was suggested to be an effective and safe treatment for such a condition aim: Providing safe and effective treatment of ocular wart. objective:
- To determine the efficacy of intralesional injection of Candida antigens in the treatment of eyelids wart
- To determine the safety of intralesional injection of Candida antigens in the treatment of eyelids wart
- To report complications of intralesional injection of Candida antigens in the treatment of eyelids wart
- Conditions
- Eye Infections
- Being tested
- Intralesional injection of Candida albicans 1:20 w/v 10 ml vial (Allergy Laboratories, INC. Oklahoma City, USA.)
- Keywords
- eyelid warts, candida antigen, eyelid papilloma
- Medical subject headings
- Eye Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intralesional injection of Candida albicans 1:20 w/v 10 ml vial (Allergy Laboratories, INC. Oklahoma City, USA.)Biological
Intralesional injection of 0.2 ml of 1/1000 solution of Candida albicans antigen using an insulin syringe directly into the warts; Candida albicans 1:20 w/v 10 ml vial (Allergy Laboratories, INC. Oklahoma City, USA.). The same injection was repeated every 2 weeks until complete clearance for a maximum of six treatment sessions.
| Study group | Role | What they receive |
|---|---|---|
| patients with eyelid warts will receive treatment in the form of intralesional injection of Candida | Experimental | Intralesional injection of 0.2 ml of 1/1000 solution of Candida albicans antigen using an insulin syringe directly into the warts; Candida albicans 1:20 w/v 10 ml vial (Allergy Laboratories, INC. Oklahoma City, USA.). The same injection was repeated every 2 weeks until complete clearance for a maximum of six treatment sessions. Receives: Biological: Intralesional injection of Candida albicans 1:20 w/v 10 ml vial (Allergy Laboratories, INC. Oklahoma City, USA.) |
What is being measured
The primary outcome is the main question the study is designed to answer.
complete response
to report the complete response defined by the efficacy of intralesional injection of Candida antigen in achieving complete disappearance of eyelid warts and return to normal skin
Measured: after maximum 6 treatment sessions of intralesional injection with 2 weeks between the successive sessions
Secondary outcomes (3)
partial response
to report Partial response which will be considered when wart regress in size by 50%-99%.
Measured: after maximum 6 treatment sessions of intralesional injection with 2 weeks between the successive sessions
Failure
to report failure which will be considered if less than 50% decrease in wart size.
Measured: after maximum 6 treatment sessions of intralesional injection with 2 weeks between the successive sessions
complications
to report any complications in the form of hypersensitivity reaction, erythema, or induration
Measured: after maximum 6 treatment sessions of intralesional injection with 2 weeks between the successive sessions
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2024
- Study start11 Jun 2024
- Primary completion15 Mar 2025
- Study completion15 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Eye InfectionsStudies of the same condition, open and under way.
- More trials run by Zagazig 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zagazig University
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Marwa Ahmed Khairy Elsayed Essa, Zagazig University
- Investigators
- Ayman Marie, Professor, Principal investigator, Professor of Medical Microbiology and Immunology, Faculty of Medicine, Zagazig University, EgyptGhada Boghdadi, Professor, Study chair, Professor of Medical Microbiology and Immunology, Faculty of Medicine, Zagazig University, Egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06720467
- Sponsor's protocol ID
- immunotherapy in eyelid warts
- Status last verified
- Dec 2024
- First submitted
- 1 Dec 2024
- Last updated
- 17 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Marei A, Nofal A, Alakad R, Abdel-Hady A. Combined bivalent human papillomavirus vaccine and Candida antigen versus Candida antigen alone in the treatment of recalcitrant warts. J Cosmet Dermatol. 2020 Mar;19(3):758-762. doi: 10.1111/jocd.13077. Epub 2019 Jul 22.
PubMed 31328869Aldahan AS, Mlacker S, Shah VV, Kamath P, Alsaidan M, Samarkandy S, Nouri K. Efficacy of intralesional immunotherapy for the treatment of warts: A review of the literature. Dermatol Ther. 2016 May;29(3):197-207. doi: 10.1111/dth.12352. Epub 2016 Mar 15.
PubMed 26991521Shaker ESE, Doghim NN, Hassan AM, Musafa SS, Fawzy MM. Immunotherapy in cutaneous warts: comparative clinical Study between MMR vaccine, tuberculin, and BCG Vaccine. J Cosmet Dermatol. 2021 Aug;20(8):2657-2666. doi: 10.1111/jocd.13921. Epub 2021 Jan 6.
PubMed 33410249
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Immunotherapy in the Treatment of Eyelid Viral Papilloma
- ClinicalTrials.gov ID
- NCT06720467
- Acronym / sponsor ID
- immunotherapy in eyelid warts
- Conditions
- Eye Infections
- Keywords
- eyelid warts, candida antigen, eyelid papilloma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Zagazig UniversityOther government
- Study start
- 11 Jun 2024 (actual)
- Primary completion
- 15 Mar 2025 (actual)
- Study completion
- 15 Jun 2025 (actual)
- First posted
- 6 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.
intralesional injection of Candida antigens for treating eyelid warts is supposed to have less destructive effect than other surgical interventions
Detailed description
Despite many surgical and interventional modalities of treating ocular warts, all have a destructive nature for this delicate tissue with a high recurrence rate. intralesional injection of Candida antigens was suggested to be an effective and safe treatment for such a condition aim: Providing safe and effective treatment of ocular wart. objective:
- To determine the efficacy of intralesional injection of Candida antigens in the treatment of eyelids wart
- To determine the safety of intralesional injection of Candida antigens in the treatment of eyelids wart
- To report complications of intralesional injection of Candida antigens in the treatment of eyelids wart
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| patients with eyelid warts will receive treatment in the form of intralesional injection of Candida | Experimental | Biological: Intralesional injection of Candida albicans 1:20 w/v 10 ml vial (Allergy Laboratories, INC. Oklahoma City, USA.)Intralesional injection of 0.2 ml of 1/1000 solution of Candida albicans antigen using an insulin syringe directly into the warts; Candida albicans 1:20 w/v 10 ml vial (Allergy Laboratories, INC. Oklahoma City, USA.). The same injection was repeated every 2 weeks until complete clearance for a maximum of six treatment sessions. |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- patients with cutaneous eyelid viral warts whether single or multiple, with no concurrent systemic or topical treatment for warts. Patients aged more than 12 years, with sensitivity test, showed induration less than or equal to five mm. and patients can understand and comply with the requirements of the trials.
Key exclusion criteria (1 listed)
- pregnancy, breastfeeding, patients with immunodeficiency; like diabetics. In addition, patients with a history of hypersensitivity to any used component in this trial, asthma, or allergic skin diseases. Moreover, patients on any treatment modality for warts at least 1 month before the start of the study.
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 |
|---|---|---|
| Intralesional injection of Candida albicans 1:20 w/v 10 ml vial (Allergy Laboratories, INC. Oklahoma City, USA.)Intralesional injection of 0.2 ml of 1/1000 solution of Candida albicans antigen using an insulin syringe directly into the warts; Candida albicans 1:20 w/v 10 ml vial (Allergy Laboratories, INC. Oklahoma City, USA.). The same injection was repeated every 2 weeks until complete clearance for a maximum of six treatment sessions. | Biological | patients with eyelid warts will receive treatment in the form of intralesional injection of Candida |
Primary outcome
complete response
Time frame: after maximum 6 treatment sessions of intralesional injection with 2 weeks between the successive sessions
to report the complete response defined by the efficacy of intralesional injection of Candida antigen in achieving complete disappearance of eyelid warts and return to normal skin
3 secondary outcomes
partial response
Time frame: after maximum 6 treatment sessions of intralesional injection with 2 weeks between the successive sessions
Failure
Time frame: after maximum 6 treatment sessions of intralesional injection with 2 weeks between the successive sessions
complications
Time frame: after maximum 6 treatment sessions of intralesional injection with 2 weeks between the successive sessions
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2025.
- Background: PubMed 31328869Marei A, Nofal A, Alakad R, Abdel-Hady A. Combined bivalent human papillomavirus vaccine and Candida antigen versus Candida antigen alone in the treatment of recalcitrant warts. J Cosmet Dermatol. 2020 Mar;19(3):758-762. doi: 10.1111/jocd.13077. Epub 2019 Jul 22.
- Background: PubMed 26991521Aldahan AS, Mlacker S, Shah VV, Kamath P, Alsaidan M, Samarkandy S, Nouri K. Efficacy of intralesional immunotherapy for the treatment of warts: A review of the literature. Dermatol Ther. 2016 May;29(3):197-207. doi: 10.1111/dth.12352. Epub 2016 Mar 15.
- Background: PubMed 33410249Shaker ESE, Doghim NN, Hassan AM, Musafa SS, Fawzy MM. Immunotherapy in cutaneous warts: comparative clinical Study between MMR vaccine, tuberculin, and BCG Vaccine. J Cosmet Dermatol. 2021 Aug;20(8):2657-2666. doi: 10.1111/jocd.13921. Epub 2021 Jan 6.
Related trials for Eye Infections
RecruitingObservational study
Pain Phenotyping of Rheumatic Diseases - An Observational Study
Rheumatic Diseases, Lupus Erythematosus, Systemic
RecruitingPhase 2
Efficacy of Locally Delivered Allogeneic Mesenchymal Stromal Cells
Corneal Ulcer
Not yet recruitingPhase 4
Evaluation of the Impact of Oral Ivermectin on Musca Sorbens Flies, Putative Vector of Trachoma
Survival of Flies Developing in Faecal Samples
RecruitingObservational study
Tissue, Blood, and Body Fluid Sample Collection From Patients With Hematologic Cancer
Chronic Myeloproliferative Disorders, Leukemia
RecruitingObservational study
Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
Rare Disorders, Undiagnosed Disorders
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. This study is not recruiting at the moment.
Ayman Marie, Professor principal investigator
Professor of Medical Microbiology and Immunology, Faculty of Medicine, Zagazig University, Egypt
Ghada Boghdadi, Professor study chair
Professor of Medical Microbiology and Immunology, Faculty of Medicine, Zagazig University, Egypt
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Intralesional injection of Candida albicans 1:20 w/v 10 ml vial (Allergy Laboratories, INC. Oklahoma City, USA.) in people with Eye Infections, run by Zagazig 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 1 inclusion and 1 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: finished, as of the sponsor's last update on 17 Aug 2025. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
complete response (time frame: after maximum 6 treatment sessions of intralesional injection with 2 weeks between the successive sessions). 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 NCT06720467, which also lists 3 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 17 Aug 2025.