Skip to main content
OpenTrials
Completed

NCT Number: NCT04278573

Intralesional Vitamin D Injection for Treatment of Common Warts

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Warts DNA Virus Infections Infections Papillomavirus Infections Skin Diseases Skin Diseases, Infectious Skin Diseases, Viral Skin and Connective Tissue Diseases Tumor Virus Infections Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Vitamin D3

Drug

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

Other names: Cholecalciferol

Placebo

Drug

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

Primary outcomes

  1. Complete Regression of Wart

    Time frame: 24 weeks

    Number of subjects to have a complete resolution of cutaneous wart

Secondary outcomes

  1. Regression of Wart at 4 Weeks

    Time frame: 4 weeks

    Number of participants who experienced complete regression of cutaneous wart at 4 weeks.

  2. Regression of Wart at 8 Weeks

    Time frame: 8 weeks

    Number of participants who experienced complete regression of cutaneous wart at 8 weeks.

  3. Regression of Wart at 12 Weeks

    Time frame: 12 weeks

    Number of participants who experienced complete regression of cutaneous wart at 12 weeks.

Sponsors and collaborators

Lead sponsor

Stephen P. Merry

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
Feb 20, 2020
Registry last updated
Apr 30, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.