Back to resultsIntralesional Vitamin D Injection for Treatment of Common Warts
Primary Purpose
Warts
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Vitamin D3
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Warts
Eligibility Criteria
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).
Sites / Locations
- Mayo Clinic
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Vitamin D3 Treatment Group
Placebo Group
Arm Description
Subjects will receive a Vitamin D3 injection into their wart
Subjects will receive a placebo injection into their wart
Outcomes
Primary Outcome Measures
Complete regression of wart
Number of subjects to have a complete resolution of cutaneous wart
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04278573
Brief Title
Intralesional Vitamin D Injection for Treatment of Common Warts
Official Title
Efficacy of Intralesional Vitamin D Injection for Treatment of Common Warts: A Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Completed
Study Start Date
October 20, 2020 (Actual)
Primary Completion Date
April 4, 2023 (Actual)
Study Completion Date
April 4, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Stephen P. Merry
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Researchers are trying to find out if injecting Vitamin D into a wart is an effective treatment.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Warts
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Vitamin D3 Treatment Group
Arm Type
Experimental
Arm Description
Subjects will receive a Vitamin D3 injection into their wart
Arm Title
Placebo Group
Arm Type
Placebo Comparator
Arm Description
Subjects will receive a placebo injection into their wart
Intervention Type
Drug
Intervention Name(s)
Vitamin D3
Other Intervention Name(s)
Cholecalciferol
Intervention Description
Intralesional injection of 0.3 ml 40,000 IU/ml vitamin D3 into one wart
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
0.3 ml injection of sterilized propylene glycol: dehydrated alcohol (9:1 ratio) with no active study ingredient
Primary Outcome Measure Information:
Title
Complete regression of wart
Description
Number of subjects to have a complete resolution of cutaneous wart
Time Frame
Approximately 5 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stephen Merry, MD
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Links:
URL
https://www.mayo.edu/research/clinical-trials
Description
Mayo Clinic Clinical Trials
Learn more about this trial
Intralesional Vitamin D Injection for Treatment of Common Warts
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