Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Researchers are trying to find out if injecting Vitamin D into a wart is an effective treatment.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vitamin D3 Treatment Group | Experimental | Subjects will receive a Vitamin D3 injection into their wart |
|
| Placebo Group | Placebo Comparator | Subjects will receive a placebo injection into their wart |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vitamin D3 | Drug | Intralesional injection of 0.3 ml 40,000 IU/ml vitamin D3 into one wart |
|
| Measure | Description | Time Frame |
|---|---|---|
| Complete Regression of Wart | Number of subjects to have a complete resolution of cutaneous wart | 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Regression of Wart at 4 Weeks | Number of participants who experienced complete regression of cutaneous wart at 4 weeks. | 4 weeks |
| Regression of Wart at 8 Weeks | Number of participants who experienced complete regression of cutaneous wart at 8 weeks. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Stephen Merry, MD | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic | Rochester | Minnesota | 55905 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40847834 | Derived | 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. |
| Label | URL |
|---|---|
| Mayo Clinic Clinical Trials | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Vitamin D3 Treatment Group | Subjects will receive a Vitamin D3 injection into their wart Vitamin D3: Intralesional injection of 0.3 ml 40,000 IU/ml vitamin D3 into one wart |
| FG001 | Placebo Group | Subjects will receive a placebo injection into their wart Placebo: 0.3 ml injection of sterilized sesame oil with no active study ingredient |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Vitamin D3 Treatment Group | Subjects will receive a Vitamin D3 injection into their wart Vitamin D3: Intralesional injection of 0.3 ml 40,000 IU/ml vitamin D3 into one wart |
| BG001 | Placebo Group |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Complete Regression of Wart | Number of subjects to have a complete resolution of cutaneous wart | Posted | Count of Participants | Participants | 24 weeks |
|
Adverse events were collected for each subject from the time of first injection of the investigational product until 112 days following the last administration of the investigational product, for a total of approximately 6 months.
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Vitamin D3 Treatment Group | Subjects will receive a Vitamin D3 injection into their wart Vitamin D3: Intralesional injection of 0.3 ml 40,000 IU/ml vitamin D3 into one wart |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Skin redness at injection site | General disorders | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Stephen P. Merry | Mayo Clinic | 507-284-5180 | merry.stephen@mayo.edu |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Dec 14, 2020 | Feb 8, 2024 | Prot_SAP_000.pdf |
Not provided
| ID | Term |
|---|---|
| D014860 | Warts |
| ID | Term |
|---|---|
| D030361 | Papillomavirus Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
| D007239 | Infections |
Not provided
Not provided
| ID | Term |
|---|---|
| D002762 | Cholecalciferol |
| ID | Term |
|---|---|
| D002782 | Cholestenes |
| D002776 | Cholestanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Placebo | Drug | 0.3 ml injection of sterilized sesame oil with no active study ingredient |
|
| 8 weeks |
| Regression of Wart at 12 Weeks | Number of participants who experienced complete regression of cutaneous wart at 12 weeks. | 12 weeks |
Subjects will receive a placebo injection into their wart
Placebo: 0.3 ml injection of sterilized sesame oil with no active study ingredient
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units | Counts |
|---|
| Participants |
|
|
| Secondary | Regression of Wart at 4 Weeks | Number of participants who experienced complete regression of cutaneous wart at 4 weeks. | Posted | Count of Participants | Participants | 4 weeks |
|
|
|
| Secondary | Regression of Wart at 8 Weeks | Number of participants who experienced complete regression of cutaneous wart at 8 weeks. | Posted | Count of Participants | Participants | 8 weeks |
|
|
|
| Secondary | Regression of Wart at 12 Weeks | Number of participants who experienced complete regression of cutaneous wart at 12 weeks. | Posted | Count of Participants | Participants | 12 weeks |
|
|
|
| 0 |
| 41 |
| 0 |
| 41 |
| 41 |
| 41 |
| EG001 | Placebo Group | Subjects will receive a placebo injection into their wart Placebo: 0.3 ml injection of sterilized sesame oil with no active study ingredient | 0 | 36 | 0 | 36 | 36 | 36 |
| Itching | General disorders | Systematic Assessment |
|
| Hematoma (blood blister) | General disorders | Systematic Assessment |
|
Not provided
Not provided
Not provided
| D017193 |
| Skin Diseases, Viral |
| D014412 | Tumor Virus Infections |
| D012874 | Skin Diseases, Infectious |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D011083 |
| Polycyclic Compounds |
| D013261 | Sterols |
| D014807 | Vitamin D |
| D012632 | Secosteroids |
| D008563 | Membrane Lipids |
| D008055 | Lipids |