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

NCT05652998 | Unknown Phase 4

• 1 other identifier: 233/9/21
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

To compare the efficacy of intralesional injection of autologous plasma rich platelets and candida antigen in treatment of patients with plane warts .

Conditions

Plane Wart

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Treatment of plane wart

  6 Months

Study Arms (3)

Candida antigen

ACTIVE COMPARATOR

patients will be injected with intralesional C.albicans antigen

Biological: C. albicans antigen

Autologous platelets rich plasma

ACTIVE COMPARATOR

patients will receive intralesional autologous PRP injection

Other: autologous PRP

Saline

PLACEBO COMPARATOR

patients will receive intralesional saline

Other: saline

Interventions

C. albicans antigen 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.

Candida antigen

autologous PRP 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.

Autologous platelets rich plasma

saline 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

Saline

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients proved as having clinically evident plane warts.
• Patients with both sexes with no age limits.

You may not qualify if:

• 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 .

Sponsors & Collaborators

• South Valley University: lead

Study Sites (1)

South Valley University

Qina, Egypt

Location

MeSH Terms

Interventions

Sodium Chloride

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• 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 DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principal investigator

Study Record Dates

• First Submitted: October 27, 2022
• First Posted: December 15, 2022
• Study Start: October 15, 2021
• Primary Completion: December 30, 2022
• Study Completion: April 15, 2023
• Last Updated: December 15, 2022

Record last verified: 2022-12

Locations

EG (1)