Back to resultsIs Involucrin Has a Role in Verruca Vulgaris? A Clinical and Immunohistochemical Study
Primary Purpose
Verruca Vulgaris, Involucrin
Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Cholecalciferol
Sponsored by
About this trial
This is an interventional treatment trial for Verruca Vulgaris
Eligibility Criteria
Inclusion criteria:
Patients with multiple verruca vulgaris Patients with with verrucae vulgaris with size more than 3 cm
Exclusion Criteria:
Patients with a past history of allergic response to vitamin D. Pregnant or lactating females. Hepatic patients. Renal patients. Patients with bleeding tendency.
Sites / Locations
- Essam Mohamed El-sayed Akl
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Cholecalciferol injection
Arm Description
Outcomes
Primary Outcome Measures
Resolution of verrucae
Decrease of verrucae size Decrease of verrucae number
Secondary Outcome Measures
Involucrin expression
Change of expression pattern of involucrin by immunohistochemical study Change of expression grade of involucrin by immunohistochemical study
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04793529
Brief Title
Is Involucrin Has a Role in Verruca Vulgaris? A Clinical and Immunohistochemical Study
Official Title
Is Involucrin Has a Role in Verruca Vulgaris? A Clinical and Immunohistochemical Study
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Completed
Study Start Date
January 1, 2019 (Actual)
Primary Completion Date
October 1, 2019 (Actual)
Study Completion Date
October 1, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Benha University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Vitamin D3 plays important role in keratinocyte differentiation and had been used recently in verruca vulgaris. Aim of the work: To assess the expression of involucrin in verrucae vulgaris before and after injection of vitamin D3. Subjects and Methods: This study included 60 patients with verrucae vulgaris subjected to intralesional injection of vitamin D3 at three weeks interval for a maximum of five sessions. Immunohistochemical assessment of involucrin was done before and after injection and compared to skin biopsies from 30 healthy individuals
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Verruca Vulgaris, Involucrin
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Cholecalciferol injection
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Cholecalciferol
Intervention Description
Cholecalciferol injection
Primary Outcome Measure Information:
Title
Resolution of verrucae
Description
Decrease of verrucae size Decrease of verrucae number
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Involucrin expression
Description
Change of expression pattern of involucrin by immunohistochemical study Change of expression grade of involucrin by immunohistochemical study
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion criteria:
Patients with multiple verruca vulgaris Patients with with verrucae vulgaris with size more than 3 cm
Exclusion Criteria:
Patients with a past history of allergic response to vitamin D. Pregnant or lactating females. Hepatic patients. Renal patients. Patients with bleeding tendency.
Facility Information:
Facility Name
Essam Mohamed El-sayed Akl
City
Banhā
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Is Involucrin Has a Role in Verruca Vulgaris? A Clinical and Immunohistochemical Study
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