Plane WartPhase 4NCT05652998
Comparison Between Intralesional Injection of Plasma Rich Platelets and Candida Antigen in Plane Warts
A Phase 4 study testing C. albicans antigen, autologous PRP and saline in people with Plane Wart, run by South Valley University at 1 site in Egypt.
Trial summary
To compare the efficacy of intralesional injection of autologous plasma rich platelets and candida antigen in treatment of patients with plane warts . Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Plane Wart
- What is being tested?
- C. albicans antigen, autologous PRP and saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Oct 2021to 15 Apr 2023
- Phase
- Phase 4
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Patients proved as having clinically evident plane warts.
- Patients with both sexes with no age limits.
Who cannot join
- Patient receiving immune suppressive drugs.
- Patients with major comorbidities or concomitant malignancies.
- Patients with any evidence of immunosuppression including HIV infection.
- Patients with any eczematous skin disorder
- Those with any history of hypersensitivity to Candida albicans antigen.
- Patients with chronic systemic medical diseases and bleeding disorders .
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparative Study Between Intralesional Injection of Autologous Plasma Rich Platelets Versus Candida Antigen in Patients With Plane Warts
To compare the efficacy of intralesional injection of autologous plasma rich platelets and candida antigen in treatment of patients with plane warts .
Read the detailed description
Cutaneous warts are benign tumors caused by infection of keratinocytes by different serotypes of human papillomavirus(HPV). Its incidence increases during the school years to reach a peak in adolescence and early adulthood, then declines rapidly through the twenties and more gradually thereafter.
Plane warts are mainly caused by HPV serotypes 3, 10, 28, and 41, presenting mainly in children and young adults. They present as skin colored or may be hyperpigmented smooth-surfaced, slightly elevated or flat-topped papules. They are polygonal or round in shape and range in sizes from 1 to 5 mm. The main sites of predilection for the plane warts are the face, dorsal aspects of the hands and forearms, often in a linear array.
Platelet rich plasma (PRP) is an autologous blood-derived product enriched in platelets. Platelets, also called thrombocytes, are blood cells that cause blood clots and other necessary growth healing functions. PRP represents a new bio technology that is part of the growing interest in tissue engineering and cellular therapy today. While it is of autologous origin, it reduces the possibility of adverse effects and transfusion-transmitted infections, so it is well-tolerated therapy for the patients. PRP has been used in the treatment of many cutaneous diseases such as alopecia and acne vulgaris. Its utility has been extended to other cutaneous diseases as melasma, hyperpigmentation, and burns, wherever it elicits tissue repair and regeneration.
Intralesional immunotherapy depends on the ability of the immune system to recognize certain viral, bacterial, and fungal antigens, such as Candida or Trichophyton antigens that induce a delayed-type hypersensitivity reaction, not only to the antigen but also against the wart virus, which in turn increases the ability of the immune system to recognize and eradicate HPV. This stimulated immune response could then subsequently destroy all the injected and noninjected lesions on the body, rather than the locally treated lesion.
Intralesional antigen immunotherapy has recently received increased attention and is considered by many authors a promising modality for the treatment of different types of warts, including the recurrent and recalcitrant variants.
- Conditions
- Plane Wart
- Being tested
- C. albicans antigen, autologous PRP, saline
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
C. albicans antigenBiological
a test dose (0.1 ml) of the C. albicans antigen will be injected intradermally into the skin of the forearm. A reaction will be considered positive in presence of ≥5 mm erythema and induration after 48-72 hr. Only reactors will be included. patients will receive intralesional injection of candida antigen at a dose 0.1 ml of 1/1000 solution into the largest wart at 3 weekly intervals for a total of 3 doses.
autologous PRPOther
patients will receive intralesional autologous PRP injection every month until a complete clearance or for a maximum of 2 sessions. 20 cc blood will be collected under a complete aseptic condition in citrate tubes . The lower 2-4 cc of the plasma will be provided as PRP concentrate after centrifugation. 0.1 ml of PRP will be injected intralesional with an insulin syringe.
salineOther
patients will receive intralesional saline at a dose of 0.3ml into the largest wart at 2-week intervals until complete clearance is achieved or for a maximum of five treatment
| Study group | Role | What they receive |
|---|---|---|
| Candida antigen | Active comparator | patients will be injected with intralesional C.albicans antigen Receives: Biological: C. albicans antigen |
| Autologous platelets rich plasma | Active comparator | patients will receive intralesional autologous PRP injection Receives: Other: autologous PRP |
| Saline | Placebo comparator | patients will receive intralesional saline Receives: Other: saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment of plane wart
Evaluation of the efficacy of intradermal injection of candida albicans antigen versus autologous platelet rich plasma in treatment of plane warts
Measured: 6 months
Secondary outcomes (1)
Treatment of plane wart
Response to treatment will be evaluated by the decrease in size of warts. Lesions with size decrease of less than 50% will be defined as no therapeutic response, size decrease between 50 and 99% as relative response, and complete removal of the lesions will be considered as complete cure.
Measured: 6 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2022
- Study start15 Oct 2021
- Primary completion30 Dec 2022 (estimated)
- Study completion15 Apr 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Plane WartStudies of the same condition, open and under way.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- South Valley University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Randa Abd Al-naser Hussien Kamel, South Valley University
- Investigators
- Hassan M Ibrahim, Ass. Prof., Study director, Faculty of Medicine - South Valley UniversityMohamed A Ali, Prof. Dr., Study director, Faculty of Medicine - Sohag UniversityEisa M Hegazy, Ass. Prof., Study director, Faculty of Medicine - South Valley University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05652998
- Sponsor's protocol ID
- 233/9/21
- Status last verified
- Dec 2022
- First submitted
- 27 Oct 2022
- Last updated
- 15 Dec 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Study Between Intralesional Injection of Autologous Plasma Rich Platelets Versus Candida Antigen in Patients With Plane Warts
- ClinicalTrials.gov ID
- NCT05652998
- Acronym / sponsor ID
- 233/9/21
- Conditions
- Plane Wart
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- South Valley UniversityUniversity, hospital or other
- Study start
- 15 Oct 2021 (actual)
- Primary completion
- 30 Dec 2022 (estimated)
- Study completion
- 15 Apr 2023 (estimated)
- First posted
- 15 Dec 2022 (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.
To compare the efficacy of intralesional injection of autologous plasma rich platelets and candida antigen in treatment of patients with plane warts .
Detailed description
Cutaneous warts are benign tumors caused by infection of keratinocytes by different serotypes of human papillomavirus(HPV). Its incidence increases during the school years to reach a peak in adolescence and early adulthood, then declines rapidly through the twenties and more gradually thereafter.
Plane warts are mainly caused by HPV serotypes 3, 10, 28, and 41, presenting mainly in children and young adults. They present as skin colored or may be hyperpigmented smooth-surfaced, slightly elevated or flat-topped papules. They are polygonal or round in shape and range in sizes from 1 to 5 mm. The main sites of predilection for the plane warts are the face, dorsal aspects of the hands and forearms, often in a linear array.
Platelet rich plasma (PRP) is an autologous blood-derived product enriched in platelets. Platelets, also called thrombocytes, are blood cells that cause blood clots and other necessary growth healing functions. PRP represents a new bio technology that is part of the growing interest in tissue engineering and cellular therapy today. While it is of autologous origin, it reduces the possibility of adverse effects and transfusion-transmitted infections, so it is well-tolerated therapy for the patients. PRP has been used in the treatment of many cutaneous diseases such as alopecia and acne vulgaris. Its utility has been extended to other cutaneous diseases as melasma, hyperpigmentation, and burns, wherever it elicits tissue repair and regeneration.
Intralesional immunotherapy depends on the ability of the immune system to recognize certain viral, bacterial, and fungal antigens, such as Candida or Trichophyton antigens that induce a delayed-type hypersensitivity reaction, not only to the antigen but also against the wart virus, which in turn increases the ability of the immune system to recognize and eradicate HPV. This stimulated immune response could then subsequently destroy all the injected and noninjected lesions on the body, rather than the locally treated lesion.
Intralesional antigen immunotherapy has recently received increased attention and is considered by many authors a promising modality for the treatment of different types of warts, including the recurrent and recalcitrant variants.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Candida antigen | Active comparator | Biological: C. albicans antigenpatients will be injected with intralesional C.albicans antigen |
| Autologous platelets rich plasma | Active comparator | Other: autologous PRPpatients will receive intralesional autologous PRP injection |
| Saline | Placebo comparator | Other: salinepatients will receive intralesional saline |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Patients proved as having clinically evident plane warts.
- Patients with both sexes with no age limits.
Key exclusion criteria (6 listed)
- Patient receiving immune suppressive drugs.
- Patients with major comorbidities or concomitant malignancies.
- Patients with any evidence of immunosuppression including HIV infection.
- Patients with any eczematous skin disorder
- Those with any history of hypersensitivity to Candida albicans antigen.
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 |
|---|---|---|
| C. albicans antigena test dose (0.1 ml) of the C. albicans antigen will be injected intradermally into the skin of the forearm. A reaction will be considered positive in presence of ≥5 mm erythema and induration after 48-72 hr. Only reactors will be included. patients will receive intralesional injection of candida antigen at a dose 0.1 ml of 1/1000 solution into the largest wart at 3 weekly intervals for a total of 3 doses. | Biological | Candida antigen |
| autologous PRPpatients will receive intralesional autologous PRP injection every month until a complete clearance or for a maximum of 2 sessions. 20 cc blood will be collected under a complete aseptic condition in citrate tubes . The lower 2-4 cc of the plasma will be provided as PRP concentrate after centrifugation. 0.1 ml of PRP will be injected intralesional with an insulin syringe. | Other | Autologous platelets rich plasma |
| salinepatients will receive intralesional saline at a dose of 0.3ml into the largest wart at 2-week intervals until complete clearance is achieved or for a maximum of five treatment | Other | Saline |
Primary outcome
Treatment of plane wart
Time frame: 6 months
Evaluation of the efficacy of intradermal injection of candida albicans antigen versus autologous platelet rich plasma in treatment of plane warts
1 secondary outcome
Treatment of plane wart
Time frame: 6 Months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Dec 2022.
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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. This study is not recruiting at the moment.
Hassan M Ibrahim, Ass. Prof. study director
Faculty of Medicine - South Valley University
Mohamed A Ali, Prof. Dr. study director
Faculty of Medicine - Sohag University
Eisa M Hegazy, Ass. Prof. study director
Faculty of Medicine - South Valley University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing C. albicans antigen, autologous PRP and saline in people with Plane Wart, run by South Valley 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 6 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: status not confirmed, as of the sponsor's last update on 15 Dec 2022. 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. Some participants in this study may receive a placebo. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
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?
Treatment of plane wart (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 Dec 2022.