Intralesional Vitamin D Injection for Treatment of Common Warts

Warts Clinical Trial

Official title:

Efficacy of Intralesional Vitamin D Injection for Treatment of Common Warts: A Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04278573
• Other study ID #: 19-010219
• Status: Completed
• Phase: Phase 2
• Start date: October 20, 2020
• Est. completion date: April 4, 2023

Study information

• Verified date: April 2024
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 77
• Est. completion date: April 4, 2023
• Est. primary completion date: April 4, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Warts

Intervention

Drug:
• Vitamin D3
Intralesional injection of 0.3 ml 40,000 IU/ml vitamin D3 into one wart
• Placebo
0.3 ml injection of sterilized sesame oil with no active study ingredient

Locations

Country	Name	City	State
United States	Mayo Clinic	Rochester	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Stephen P. Merry

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Complete Regression of Wart	Number of subjects to have a complete resolution of cutaneous wart	24 weeks
Secondary	Regression of Wart at 4 Weeks	Number of participants who experienced complete regression of cutaneous wart at 4 weeks.	4 weeks
Secondary	Regression of Wart at 8 Weeks	Number of participants who experienced complete regression of cutaneous wart at 8 weeks.	8 weeks
Secondary	Regression of Wart at 12 Weeks	Number of participants who experienced complete regression of cutaneous wart at 12 weeks.	12 weeks