NCT04399577

Brief Summary

The investigators explore the role of the complement pathway and T helper 1 immune response in clinical response to Candida immunotherapy via complement component and tumor necrosis factor, respectively.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
39

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Jul 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2017

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 3, 2019

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 3, 2019

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

May 19, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 22, 2020

Completed
Last Updated

May 27, 2020

Status Verified

May 1, 2020

Enrollment Period

1.7 years

First QC Date

May 19, 2020

Last Update Submit

May 24, 2020

Conditions

Warts

Outcome Measures

Primary Outcomes (1)

  • Resolution of warts

    100% clearance of warts

    12 weeks

Secondary Outcomes (1)

  • Recurrence

    6 months

Study Arms (1)

Wart Patients

EXPERIMENTAL

Patient receive 0.1 mL of diluted preparation of candida solution at 2 weeks interval for the maximum of 5 sessions

Biological: Candida antigen

Interventions

Candida antigenBIOLOGICAL

Patient receive candida antigen immunotherapy and blood samples will be withdrawn before and after intervention

Wart Patients

Eligibility Criteria

Age9 Years - 45 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Chronic multiple cutaneous

You may not qualify if:

  • Hypersensitivity to Candida antigen
  • Fever
  • Immunosuppressive disorders
  • Previous wart therapy in the last month

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Zagazig University Faculty of Medicine

Zagazig, Sharqia Province, 44519, Egypt

Location

Related Publications (1)

  • Hammad NM, Abdelhadi AA, Fawzy MM, Marei A. Complement component 3c and tumor necrosis factor-alpha systemic assessment after Candida antigen immunotherapy in cutaneous warts. Braz J Microbiol. 2020 Dec;51(4):1673-1681. doi: 10.1007/s42770-020-00322-0. Epub 2020 Jun 27.

    PMID: 32594377DERIVED

MeSH Terms

Conditions

Warts

Interventions

PRA1 protein, Candida albicans

Condition Hierarchy (Ancestors)

Papillomavirus InfectionsDNA Virus InfectionsVirus DiseasesInfectionsSkin Diseases, ViralTumor Virus InfectionsSkin Diseases, InfectiousSkin DiseasesSkin and Connective Tissue Diseases

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

May 19, 2020

First Posted

May 22, 2020

Study Start

July 1, 2017

Primary Completion

March 3, 2019

Study Completion

September 3, 2019

Last Updated

May 27, 2020

Record last verified: 2020-05

Locations

EG(1)