Complement Component 3c and Tumor Necrosis Factor-α in Patients With Human Papillomavirus-Induced Cutaneous Warts

NCT ID: NCT04399577

Last Updated: 2020-05-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

39 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-07-01

Study Completion Date

2019-09-03

Brief Summary

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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.

Detailed Description

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39 patients are enrolled in the study They suffer from chronic recurrent cutaneous warts Patients receive Candida antigen immunotherapy vial intra-lesional injection every 2 weeks till complete resolution or the maximum of 5 sessions Blood samples are withdrawn before and after intervention C3, C4, MBL, C3C and TNF alpha serum levels are measured

Conditions

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Warts

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Wart Patients

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

Group Type EXPERIMENTAL

Candida antigen

Intervention Type BIOLOGICAL

Patient receive candida antigen immunotherapy and blood samples will be withdrawn before and after intervention

Interventions

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Candida antigen

Patient receive candida antigen immunotherapy and blood samples will be withdrawn before and after intervention

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

* Chronic multiple cutaneous

Exclusion Criteria

* Hypersensitivity to Candida antigen
* Fever
* Immunosuppressive disorders
* Previous wart therapy in the last month
Minimum Eligible Age

9 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Zagazig University

OTHER_GOV

Sponsor Role lead

Responsible Party

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Noha M Hammad, MD

Principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Zagazig University Faculty of Medicine

Zagazig, Sharqia Province, Egypt

Site Status

Countries

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Egypt

References

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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.

Reference Type DERIVED
PMID: 32594377 (View on PubMed)

Other Identifiers

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3140/23-10-2016

Identifier Type: -

Identifier Source: org_study_id

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