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Comparison Between Intralesional Injection of Plasma Rich Platelets and Candida Antigen in Plane Warts

Primary Purpose

Plane Wart

Status
Active
Phase
Phase 4
Locations
Egypt
Study Type
Interventional
Intervention
C. albicans antigen
autologous PRP
saline
Sponsored by
Qena Faculty of medicine, South Valley University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Plane Wart

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Patients proved as having clinically evident plane warts. Patients with both sexes with no age limits. Exclusion Criteria: 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 .

Sites / Locations

  • South Valley University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Placebo Comparator

Arm Label

Candida antigen

Autologous platelets rich plasma

Saline

Arm Description

patients will be injected with intralesional C.albicans antigen

patients will receive intralesional autologous PRP injection

patients will receive intralesional saline

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.

Full Information

First Posted
October 27, 2022
Last Updated
December 7, 2022
Sponsor
Qena Faculty of medicine, South Valley University
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1. Study Identification

Unique Protocol Identification Number
NCT05652998
Brief Title
Comparison Between Intralesional Injection of Plasma Rich Platelets and Candida Antigen in Plane Warts
Official Title
Comparative Study Between Intralesional Injection of Autologous Plasma Rich Platelets Versus Candida Antigen in Patients With Plane Warts
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
October 15, 2021 (Actual)
Primary Completion Date
December 30, 2022 (Anticipated)
Study Completion Date
April 15, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Qena Faculty of medicine, South Valley University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Plane Wart

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Candida antigen
Arm Type
Active Comparator
Arm Description
patients will be injected with intralesional C.albicans antigen
Arm Title
Autologous platelets rich plasma
Arm Type
Active Comparator
Arm Description
patients will receive intralesional autologous PRP injection
Arm Title
Saline
Arm Type
Placebo Comparator
Arm Description
patients will receive intralesional saline
Intervention Type
Biological
Intervention Name(s)
C. albicans antigen
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
autologous PRP
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
saline
Intervention Description
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
Primary Outcome Measure Information:
Title
Treatment of plane wart
Description
Evaluation of the efficacy of intradermal injection of candida albicans antigen versus autologous platelet rich plasma in treatment of plane warts
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Treatment of plane wart
Description
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.
Time Frame
6 Months

10. Eligibility

Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Patients proved as having clinically evident plane warts. Patients with both sexes with no age limits. Exclusion Criteria: 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 .
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hassan M Ibrahim, Ass. Prof.
Organizational Affiliation
Faculty of Medicine - South Valley University
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Mohamed A Ali, Prof. Dr.
Organizational Affiliation
Faculty of Medicine - Sohag University
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Eisa M Hegazy, Ass. Prof.
Organizational Affiliation
Faculty of Medicine - South Valley University
Official's Role
Study Director
Facility Information:
Facility Name
South Valley University
City
Qinā
Country
Egypt

12. IPD Sharing Statement

Learn more about this trial

Comparison Between Intralesional Injection of Plasma Rich Platelets and Candida Antigen in Plane Warts

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