WartsPhase 2NCT04278573
Intralesional Vitamin D Injection for Treatment of Common Warts
A Phase 2 study testing Vitamin D3 in people with Warts, run by Stephen P. Merry at 1 site in United States.
Trial summary
Researchers are trying to find out if injecting Vitamin D into a wart is an effective treatment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Warts
- What is being tested?
- Vitamin D3
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 77 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Oct 2020to 4 Apr 2023
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Warts
- Being tested
- Vitamin D3, Placebo
- Medical subject headings
- Warts
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin D3Drug
Also called Cholecalciferol
Intralesional injection of 0.3 ml 40,000 IU/ml vitamin D3 into one wart
PlaceboDrug
0.3 ml injection of sterilized sesame oil with no active study ingredient
| Study group | Role | What they receive |
|---|---|---|
| Vitamin D3 Treatment Group | Experimental | Subjects will receive a Vitamin D3 injection into their wart Receives: Drug: Vitamin D3 |
| Placebo Group | Placebo comparator | Subjects will receive a placebo injection into their wart Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete Regression of Wart
Number of subjects to have a complete resolution of cutaneous wart
Measured: 24 weeks
Secondary outcomes (3)
Regression of Wart at 4 Weeks
Number of participants who experienced complete regression of cutaneous wart at 4 weeks.
Measured: 4 weeks
Regression of Wart at 8 Weeks
Number of participants who experienced complete regression of cutaneous wart at 8 weeks.
Measured: 8 weeks
Regression of Wart at 12 Weeks
Number of participants who experienced complete regression of cutaneous wart at 12 weeks.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2020
- Study start20 Oct 2020
- Primary completion4 Apr 2023
- Study completion4 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for WartsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 77 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stephen P. Merry
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Stephen P. Merry, Mayo Clinic
- Investigators
- Stephen Merry, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04278573
- Sponsor's protocol ID
- 19-010219
- Status last verified
- Apr 2024
- First submitted
- 18 Feb 2020
- Last updated
- 30 Apr 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 40847834
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Intralesional Vitamin D Injection for Treatment of Common Warts: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04278573
- Acronym / sponsor ID
- 19-010219
- Conditions
- Warts
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 77 participants (actual)
- Lead sponsor
- Stephen P. MerryUniversity, hospital or other
- Study start
- 20 Oct 2020 (actual)
- Primary completion
- 4 Apr 2023 (actual)
- Study completion
- 4 Apr 2023 (actual)
- First posted
- 20 Feb 2020 (actual)
- Results
- Posted 30 Apr 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Researchers are trying to find out if injecting Vitamin D into a wart is an effective treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vitamin D3 Treatment Group | Experimental | Drug: Vitamin D3Subjects will receive a Vitamin D3 injection into their wart |
| Placebo Group | Placebo comparator | Drug: PlaceboSubjects will receive a placebo injection into their wart |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vitamin D3Also: CholecalciferolIntralesional injection of 0.3 ml 40,000 IU/ml vitamin D3 into one wart | Drug | Vitamin D3 Treatment Group |
| Placebo0.3 ml injection of sterilized sesame oil with no active study ingredient | Drug | Placebo Group |
Primary outcome
Complete Regression of Wart
Time frame: 24 weeks
Number of subjects to have a complete resolution of cutaneous wart
3 secondary outcomes
Regression of Wart at 4 Weeks
Time frame: 4 weeks
Regression of Wart at 8 Weeks
Time frame: 8 weeks
Regression of Wart at 12 Weeks
Time frame: 12 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 40847834Merry 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.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stephen Merry, MD principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Vitamin D3 in people with Warts, run by Stephen P. Merry at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 30 Apr 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Complete Regression of Wart (time frame: 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04278573, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Apr 2024.