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

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 .

Study Overview

• Status: Active, not recruiting
• Conditions: Plane Wart
• Intervention / Treatment: Biological: C. albicans antigen; Other: autologous PRP; Other: saline

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 Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Phase 4

Contacts and Locations

Study Locations

• Egypt
  • Qinā, Egypt
    • South Valley University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 .

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Candida antigen; patients will be injected with intralesional C.albicans antigen	Biological: C. albicans antigen; 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.
Active Comparator: Autologous platelets rich plasma; patients will receive intralesional autologous PRP injection	Other: autologous PRP; 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.
Placebo Comparator: Saline; patients will receive intralesional saline	Other: saline; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	6 Months

Collaborators and Investigators

• Sponsor: Qena Faculty of medicine, South Valley University
• Investigators: Study Director: Hassan M Ibrahim, Ass. Prof., Faculty of Medicine - South Valley University; Study Director: Mohamed A Ali, Prof. Dr., faculty of medicine - Sohag university; Study Director: Eisa M Hegazy, Ass. Prof., Faculty of Medicine - South Valley University

Study record dates

Study Major Dates

• Study Start (Actual): October 15, 2021
• Primary Completion (Anticipated): December 30, 2022
• Study Completion (Anticipated): April 15, 2023

Study Registration Dates

• First Submitted: October 27, 2022
• First Submitted That Met QC Criteria: December 7, 2022
• First Posted (Estimate): December 15, 2022

Study Record Updates

• Last Update Posted (Estimate): December 15, 2022
• Last Update Submitted That Met QC Criteria: December 7, 2022
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Virus Diseases; Infections; DNA Virus Infections; Skin Diseases, Infectious; Papillomavirus Infections; Skin Diseases, Viral; Tumor Virus Infections; Warts
• Other Study ID Numbers: 233/9/21

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No