Clinical trial NCT05652998: 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
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Plane Wart
Lead sponsor: South Valley University
Sponsor class: OTHER
First posted: 2022-12-15
Enrollment: 30
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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 .

Primary outcomes:
measure: Treatment of plane wart
timeFrame: 6 months
Secondary outcomes:
measure: Treatment of plane wart
timeFrame: 6 Months
Other outcomes:
Locations:
city: Qinā
country: Egypt
facility: South Valley University
Study officials:
affiliation: Faculty of Medicine - South Valley University
name: Hassan M Ibrahim, Ass. Prof.
role: STUDY_DIRECTOR
affiliation: Faculty of Medicine - Sohag University
name: Mohamed A Ali, Prof. Dr.
role: STUDY_DIRECTOR
affiliation: Faculty of Medicine - South Valley University
name: Eisa M Hegazy, Ass. Prof.
role: STUDY_DIRECTOR
References: