Is Involucrin Has a Role in Verruca Vulgaris? A Clinical and Immunohistochemical Study

• Sponsor: Benha University (Other)
• Overall Status: Completed
• CT.gov ID: NCT04793529
• Collaborator: (none)
• Enrollment: 60
• Location: 1
• Arm: 1
• Actual Duration (Months): 9
• Patients Per Site Per Month: 6.7

Study Details

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

Condition or Disease	Intervention/Treatment	Phase
Verruca Vulgaris; Involucrin	Drug: Cholecalciferol	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 60 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Is Involucrin Has a Role in Verruca Vulgaris? A Clinical and Immunohistochemical Study
• Actual Study Start Date: Jan 1, 2019
• Actual Primary Completion Date: Oct 1, 2019
• Actual Study Completion Date: Oct 1, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Cholecalciferol injection	Drug: Cholecalciferol; Cholecalciferol injection

Outcome Measures

Primary Outcome Measures

1. Resolution of verrucae [3 months]

   Decrease of verrucae size Decrease of verrucae number

Secondary Outcome Measures

1. Involucrin expression [3 months]

   Change of expression pattern of involucrin by immunohistochemical study Change of expression grade of involucrin by immunohistochemical study

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Essam Mohamed El-sayed Akl	Banhā		Egypt

Sponsors and Collaborators

• Benha University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Essam Mohamed El-sayed Akl, Assistant Professor, Benha University
• ClinicalTrials.gov Identifier: NCT04793529
• Other Study ID Numbers: RC-2-3-2021
• First Posted: Mar 11, 2021
• Last Update Posted: Mar 11, 2021
• Last Verified: Mar 1, 2021

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Warts; Cholecalciferol; Vitamin D

Study Results

No Results Posted as of Mar 11, 2021