NCT04793529

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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2019

Shorter than P25 for not_applicable

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2019

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2019

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

March 4, 2021

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 11, 2021

Completed
Last Updated

July 27, 2023

Status Verified

July 1, 2023

Enrollment Period

9 months

First QC Date

March 4, 2021

Last Update Submit

July 25, 2023

Conditions

Verruca VulgarisInvolucrin

Outcome Measures

Primary Outcomes (1)

  • Resolution of verrucae

    Decrease of verrucae size Decrease of verrucae number

    3 months

Secondary Outcomes (1)

  • Involucrin expression

    3 months

Study Arms (1)

Cholecalciferol injection

EXPERIMENTAL
Drug: Cholecalciferol

Interventions

CholecalciferolDRUG

Cholecalciferol injection

Cholecalciferol injection

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Patients with multiple verruca vulgaris Patients with with verrucae vulgaris with size more than 3 cm

You may not qualify if:

  • Patients with a past history of allergic response to vitamin D. Pregnant or lactating females. Hepatic patients. Renal patients. Patients with bleeding tendency.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Essam Mohamed El-sayed Akl

Banhā, Egypt

Location

MeSH Terms

Conditions

Warts

Interventions

Cholecalciferol

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

CholestenesCholestanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSterolsVitamin DSecosteroidsMembrane LipidsLipids

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

March 4, 2021

First Posted

March 11, 2021

Study Start

January 1, 2019

Primary Completion

October 1, 2019

Study Completion

October 1, 2019

Last Updated

July 27, 2023

Record last verified: 2023-07

Locations

EG(1)