ClinicalTrials.gg
CompletedNCT04278573Updated Apr 30, 2024Results posted

Intralesional Vitamin D Injection for Treatment of Common Warts

A Phase 2 interventional study of Vitamin D3 and Placebo in Warts, sponsored by Stephen P. Merry. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-04-30.

Sponsored by Stephen P. Merry · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
77
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 59 studies in Warts with a site in United States — 7 open to participants now, 10 under way, 4 of them phase 3. Warts · United States.

Enrollment
30th of 58
77 · median 80
Started
2020
with 1 other
Phase 2
23 of 59
1 open now
Registered
43rd of 59
by date

Among the 59 studies in Warts with a site in United States, this one is the 30th largest by enrollment of the 58 interventional ones that give a count, is one of 2 that started in 2020, is one of 23 in phase 2, and was the 43rd registered.

Warts

171 studies on the registry are indexed under Warts; 35 are open to participants now.

Browse Warts studies →

Open to participants now

7 of the 59 studies in Warts with a site in United States are open now. Recruiting first, the newest first:

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All 7 open studies →

A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →

Who these studies take

Of the 18 Warts studies recruiting now, 10 (56%) set no upper age limit and 8 (44%) stop at 75 or younger; 12 take children under 18; 1 takes healthy volunteers.

This study: 18 Years and older · all sexes · no healthy volunteers.

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02

Study summary

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

03

Conditions studied

  • Warts

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04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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)
  • (to include immunosuppressive medications or conditions as judged by the physician evaluating the patient at the baseline visit).
  • Allergy to sesame oil
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Immunosuppression

A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.

Read whether the line is about a condition or about medicines, and which medicines and doses it means.

05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
77 participants (actual)

Study arms

  • Experimental
    Vitamin D3 Treatment Group

    Subjects will receive a Vitamin D3 injection into their wart

    Drug: Vitamin D3

  • Placebo comparator
    Placebo Group

    Subjects will receive a placebo injection into their wart

    Drug: Placebo

Interventions

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

    Also known as: Cholecalciferol

  • DrugPlacebo

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

06

What researchers measure

Primary outcomes

  1. Complete Regression of Wart

    Number of subjects to have a complete resolution of cutaneous wart

    Time frame: 24 weeks

Secondary outcomes

  1. Regression of Wart at 4 Weeks

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

    Time frame: 4 weeks

  2. Regression of Wart at 8 Weeks

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

    Time frame: 8 weeks

  3. Regression of Wart at 12 Weeks

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

    Time frame: 12 weeks

07

Results

Posted Apr 30, 2024

Participant flow

Participant flow — Overall Study
MilestoneVitamin D3 Treatment GroupPlacebo Group
Started4136
Completed4136
Not completed00

Outcome measures

PrimaryComplete Regression of Wart

Number of subjects to have a complete resolution of cutaneous wart

Time frame:
24 weeks
Reported as:
Count of participants · Participants
Complete Regression of Wart
ParticipantsVitamin D3 Treatment GroupPlacebo Group
Complete Regression of Wart1210
SecondaryRegression of Wart at 4 Weeks

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

Time frame:
4 weeks
Reported as:
Count of participants · Participants
Regression of Wart at 4 Weeks
ParticipantsVitamin D3 Treatment GroupPlacebo Group
Regression of Wart at 4 Weeks22
SecondaryRegression of Wart at 8 Weeks

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

Time frame:
8 weeks
Reported as:
Count of participants · Participants
Regression of Wart at 8 Weeks
ParticipantsVitamin D3 Treatment GroupPlacebo Group
Regression of Wart at 8 Weeks47
SecondaryRegression of Wart at 12 Weeks

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

Time frame:
12 weeks
Reported as:
Count of participants · Participants
Regression of Wart at 12 Weeks
ParticipantsVitamin D3 Treatment GroupPlacebo Group
Regression of Wart at 12 Weeks78

Adverse events

Collected over 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.. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Vitamin D3 Treatment Group0/41 (0%)0/41 (0%)41/41 (100%)
Placebo Group0/36 (0%)0/36 (0%)36/36 (100%)
Most frequent other events
Most frequent other events
EventVitamin D3 Treatment GroupPlacebo Group
ItchingGeneral disorders19/4119/36
Skin redness at injection siteGeneral disorders15/4115/36
Hematoma (blood blister)General disorders7/412/36

Baseline characteristics

Age, Continuous
Age, Continuous(years)Vitamin D3 Treatment GroupPlacebo GroupTotal
Mean36.7 ± 11.033.6 ± 10.135.3 ± 10.6
Sex: Female, Male
Sex: Female, Male(Participants)Vitamin D3 Treatment GroupPlacebo GroupTotal
Female322658
Male91019
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)Vitamin D3 Treatment GroupPlacebo GroupTotal
Hispanic or Latino022
Not Hispanic or Latino413475
Unknown or Not Reported000
Race (NIH/OMB)
Race (NIH/OMB)(Participants)Vitamin D3 Treatment GroupPlacebo GroupTotal
American Indian or Alaska Native000
Asian000
Native Hawaiian or Other Pacific Islander000
Black or African American000
White413677
More than one race000
Unknown or Not Reported000
Region of Enrollment
Region of Enrollment(participants)Vitamin D3 Treatment GroupPlacebo GroupTotal
United States413677
08

Study locations

1 site
  • Mayo Clinic
    Rochester, Minnesota 55905, United States
09

References and documents

Study documents

PDFs hosted by the registry, ClinicalTrials.gov.

Individual participant data

Plan to share: No

10

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Oct 2020 to primary completion in Apr 2023, 29 months.

Results were first posted in Apr 2024, 1 year after primary completion.

Of 18 phase 2 interventional studies under Warts, half reached primary completion within 13 months of starting (the median), counting those still running; a quarter within 7 and three quarters within 23. This study's 29 months is above that.

How these figures are worked out, and which studies are left out of them.

Registered
Feb 18, 2020
First posted
Feb 20, 2020
StartActual
Oct 20, 2020
Primary completionActual
Apr 4, 2023
CompletionActual
Apr 4, 2023
Results first posted
Apr 30, 2024
Last update
Apr 30, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Apr 30, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT04278573
Lead sponsor
Stephen P. Merry
Responsible party
Stephen P. Merry (Principal Investigator, Mayo Clinic) — Sponsor-investigator
First posted
Feb 20, 2020
Start date
Oct 20, 2020
Primary completion
Apr 4, 2023
Completion
Apr 4, 2023
Results posted
Apr 30, 2024
Last update
Apr 30, 2024

Study contacts

Stephen Merry, MD
principal investigator · Mayo Clinic

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2024. You cannot join it, but the record below documents what was studied.

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Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

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Studies of the drug tested here: Cholecalciferol

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