- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04278573
Intralesional Vitamin D Injection for Treatment of Common Warts
July 21, 2023 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
Study Type
Interventional
Enrollment (Actual)
60
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
-
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Minnesota
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Rochester, Minnesota, United States, 55905
- Mayo Clinic
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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 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).
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
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Intralesional injection of 0.3 ml 40,000 IU/ml vitamin D3 into one wart
Other Names:
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Placebo Comparator: Placebo Group
Subjects will receive a placebo injection into their wart
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0.3 ml injection of sterilized propylene glycol: dehydrated alcohol (9:1 ratio) 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: Approximately 5 months
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Number of subjects to have a complete resolution of cutaneous wart
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Approximately 5 months
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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 (Estimated)
July 24, 2023
Last Update Submitted That Met QC Criteria
July 21, 2023
Last Verified
July 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Skin Diseases
- Virus Diseases
- Infections
- DNA Virus Infections
- Skin Diseases, Infectious
- Papillomavirus Infections
- Skin Diseases, Viral
- Tumor Virus Infections
- Warts
- Physiological Effects of Drugs
- Micronutrients
- Vitamins
- Bone Density Conservation Agents
- Calcium-Regulating Hormones and Agents
- Vitamin D
- Cholecalciferol
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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