Intralesional Vitamin D Injection for Treatment of Common Warts

April 3, 2024 updated by: Stephen P. Merry

Efficacy of Intralesional Vitamin D Injection for Treatment of Common Warts: A Randomized Controlled Trial

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

77

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Vitamin D3 Treatment Group
Subjects will receive a Vitamin D3 injection into their wart
Drug: Vitamin D3
Intralesional injection of 0.3 ml 40,000 IU/ml vitamin D3 into one wart
Other Names:
  • Cholecalciferol
Placebo Comparator: Placebo Group
Subjects will receive a placebo injection into their wart
Drug: Placebo
0.3 ml injection of sterilized sesame oil with no active study ingredient

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Complete Regression of Wart
Time Frame: 24 weeks
Number of subjects to have a complete resolution of cutaneous wart
24 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Regression of Wart at 4 Weeks
Time Frame: 4 weeks
Number of participants who experienced complete regression of cutaneous wart at 4 weeks.
4 weeks
Regression of Wart at 8 Weeks
Time Frame: 8 weeks
Number of participants who experienced complete regression of cutaneous wart at 8 weeks.
8 weeks
Regression of Wart at 12 Weeks
Time Frame: 12 weeks
Number of participants who experienced complete regression of cutaneous wart at 12 weeks.
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Stephen P. Merry

Investigators

  • Principal Investigator: Stephen Merry, MD, Mayo Clinic

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 20, 2020

Primary Completion (Actual)

April 4, 2023

Study Completion (Actual)

April 4, 2023

Study Registration Dates

First Submitted

February 18, 2020

First Submitted That Met QC Criteria

February 18, 2020

First Posted (Actual)

February 20, 2020

Study Record Updates

Last Update Posted (Actual)

April 30, 2024

Last Update Submitted That Met QC Criteria

April 3, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 19-010219

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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