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

NCT ID: NCT05652998

Last Updated: 2022-12-15

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-10-15
• Study Completion Date: 2023-04-15

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.

Conditions

Plane Wart

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Candida antigen

patients will be injected with intralesional C.albicans antigen

Group Type: ACTIVE_COMPARATOR

C. albicans antigen

Intervention Type: BIOLOGICAL

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 platelets rich plasma

patients will receive intralesional autologous PRP injection

Group Type: ACTIVE_COMPARATOR

autologous PRP

Intervention Type: OTHER

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.

Saline

patients will receive intralesional saline

Group Type: PLACEBO_COMPARATOR

saline

Intervention Type: OTHER

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

Interventions

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.

Intervention Type: BIOLOGICAL

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.

Intervention Type: 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

Intervention Type: OTHER

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 .

• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

South Valley University

OTHER

Sponsor Role: lead

Responsible Party

Randa Abd Al-naser Hussien Kamel

principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Hassan M Ibrahim, Ass. Prof.

Role: STUDY_DIRECTOR

Faculty of Medicine - South Valley University

Mohamed A Ali, Prof. Dr.

Role: STUDY_DIRECTOR

Faculty of Medicine - Sohag University

Eisa M Hegazy, Ass. Prof.

Role: STUDY_DIRECTOR

Faculty of Medicine - South Valley University

Locations

South Valley University

Qina, , Egypt

Countries

Egypt

Other Identifiers

233/9/21

Identifier Type: -

Identifier Source: org_study_id