Warts
Conditions
Brief summary
Researchers are trying to find out if injecting Vitamin D into a wart is an effective treatment.
Interventions
DRUGVitamin D3
Intralesional injection of 0.3 ml 40,000 IU/ml vitamin D3 into one wart
DRUGPlacebo
0.3 ml injection of sterilized sesame oil with no active study ingredient
Sponsors
Stephen P. Merry
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Complete Regression of Wart | 24 weeks | Number of subjects to have a complete resolution of cutaneous wart |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Regression of Wart at 4 Weeks | 4 weeks | Number of participants who experienced complete regression of cutaneous wart at 4 weeks. |
| Regression of Wart at 8 Weeks | 8 weeks | Number of participants who experienced complete regression of cutaneous wart at 8 weeks. |
| Regression of Wart at 12 Weeks | 12 weeks | Number of participants who experienced complete regression of cutaneous wart at 12 weeks. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 41 |
| 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 | 36 |
| Total | 77 |
Baseline characteristics
| Characteristic | Vitamin D3 Treatment Group | Total | Placebo Group |
|---|---|---|---|
| Age, Continuous | 36.7 years STANDARD_DEVIATION 11 | 35.3 years STANDARD_DEVIATION 10.6 | 33.6 years STANDARD_DEVIATION 10.1 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 2 Participants | 2 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 41 Participants | 75 Participants | 34 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 41 Participants | 77 Participants | 36 Participants |
| Region of Enrollment United States | 41 participants | 77 participants | 36 participants |
| Sex: Female, Male Female | 32 Participants | 58 Participants | 26 Participants |
| Sex: Female, Male Male | 9 Participants | 19 Participants | 10 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 41 | 0 / 36 |
| other Total, other adverse events | 41 / 41 | 36 / 36 |
| serious Total, serious adverse events | 0 / 41 | 0 / 36 |
Outcome results
Primary
Complete Regression of Wart
Number of subjects to have a complete resolution of cutaneous wart
Time frame: 24 weeks
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Vitamin D3 Treatment Group | Complete Regression of Wart | 12 Participants |
| Placebo Group | Complete Regression of Wart | 10 Participants |
Secondary
Regression of Wart at 12 Weeks
Number of participants who experienced complete regression of cutaneous wart at 12 weeks.
Time frame: 12 weeks
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Vitamin D3 Treatment Group | Regression of Wart at 12 Weeks | 7 Participants |
| Placebo Group | Regression of Wart at 12 Weeks | 8 Participants |
Secondary
Regression of Wart at 4 Weeks
Number of participants who experienced complete regression of cutaneous wart at 4 weeks.
Time frame: 4 weeks
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Vitamin D3 Treatment Group | Regression of Wart at 4 Weeks | 2 Participants |
| Placebo Group | Regression of Wart at 4 Weeks | 2 Participants |
Secondary
Regression of Wart at 8 Weeks
Number of participants who experienced complete regression of cutaneous wart at 8 weeks.
Time frame: 8 weeks
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Vitamin D3 Treatment Group | Regression of Wart at 8 Weeks | 4 Participants |
| Placebo Group | Regression of Wart at 8 Weeks | 7 Participants |