NCT04278573

Brief Summary

Researchers are trying to find out if injecting Vitamin D into a wart is an effective treatment.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
77

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Oct 2020

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

First Submitted

Initial submission to the registry

February 18, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 20, 2020

Completed
8 months until next milestone

Study Start

First participant enrolled

October 20, 2020

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 4, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 4, 2023

Completed
1.1 years until next milestone

Results Posted

Study results publicly available

April 30, 2024

Completed
Last Updated

April 30, 2024

Status Verified

April 1, 2024

Enrollment Period

2.5 years

First QC Date

February 18, 2020

Results QC Date

April 3, 2024

Last Update Submit

April 3, 2024

Conditions

Warts

Outcome Measures

Primary Outcomes (1)

  • Complete Regression of Wart

    Number of subjects to have a complete resolution of cutaneous wart

    24 weeks

Secondary Outcomes (3)

  • Regression of Wart at 4 Weeks

    4 weeks

  • Regression of Wart at 8 Weeks

    8 weeks

  • Regression of Wart at 12 Weeks

    12 weeks

Study Arms (2)

Vitamin D3 Treatment Group

EXPERIMENTAL

Subjects will receive a Vitamin D3 injection into their wart

Drug: Vitamin D3

Placebo Group

PLACEBO COMPARATOR

Subjects will receive a placebo injection into their wart

Drug: Placebo

Interventions

Vitamin D3DRUG

Intralesional injection of 0.3 ml 40,000 IU/ml vitamin D3 into one wart

Also known as: Cholecalciferol
Vitamin D3 Treatment Group
PlaceboDRUG

0.3 ml injection of sterilized sesame oil with no active study ingredient

Placebo Group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adult patients seen at the Mayo Clinic Rochester practices
  • Patients suffering from one or more cutaneous warts as diagnosed by the examining physician at baseline visit on typical diagnostic characteristics
  • Able to provide consent
  • Both recalcitrant and non-recalcitrant warts will be included

You may not qualify if:

  • Patients with prior use of home or office-based destructive treatments for this wart(s) in the last 1 month with salicylic acid (SA) or cryotherapy
  • Immunoadjuvant therapy for warts in the last 4 months (e.g Candida)
  • History of vitamin D injection of warts ever
  • High-dose vitamin D supplementation (\>4,000 IU daily or equivalent) in the preceding 3 months
  • Pregnancy or lactation
  • Facial or genital warts
  • Lesions not felt by the examining clinician to be a wart (e.g., corns or calluses)
  • Immunosuppression (to include immunosuppressive medications or conditions as judged by the physician evaluating the patient at the baseline visit).
  • Allergy to sesame oil

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Related Publications (1)

  • Merry SP, Brennan DN, Duvall MJ, Stanek JB, O'Dowd EK, Thacher TD. Intralesional Injection of Vitamin D3 for Treatment of Cutaneous Warts: A Randomized, Double-Blind, Placebo-Controlled Trial. J Prim Care Community Health. 2025 Jan-Dec;16:21501319251365853. doi: 10.1177/21501319251365853. Epub 2025 Aug 23.

    PMID: 40847834DERIVED

Related Links

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

Results Point of Contact

Title
Dr. Stephen P. Merry
Organization
Mayo Clinic
merry.stephen@mayo.edu
507-284-5180

Study Officials

  • Stephen Merry, MD

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

February 18, 2020

First Posted

February 20, 2020

Study Start

October 20, 2020

Primary Completion

April 4, 2023

Study Completion

April 4, 2023

Last Updated

April 30, 2024

Results First Posted

April 30, 2024

Record last verified: 2024-04

Data Sharing

IPD Sharing
Will not share

Locations

US(1)