NCT05652998

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

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: South Valley University · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Accepted

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.

Conditions

• Plane Wart

Interventions

Type	Name	Description
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.
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.
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

Timeline

• Start date: 2021-10-15
• Primary completion: 2022-12-30
• Completion: 2023-04-15
• First posted: 2022-12-15
• Last updated: 2022-12-15

Locations

1 site across 1 country: Egypt