Intralesional Vitamin D Injection for Treatment of Common Warts

Phase 2

Completed

• Conditions: Warts
• Interventions: Drug: Vitamin D3; Drug: Placebo

• Registration Number: NCT04278573
• Lead Sponsor: Stephen P. Merry

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-02-18
• Study First Submitted QC: 2020-02-18
• Study First Posted: 2020-02-20
• Study Start: 2020-10-20
• Primary Completion: 2023-04-04
• Study Completion: 2023-04-04
• Status Verified: 2024-04
• Results First Submitted: 2024-04-03
• Results First Submitted QC: 2024-04-03
• Last Update Submitted: 2024-04-03
• Results First Posted: 2024-04-30
• Last Update Posted: 2024-04-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 77

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Vitamin D3 Treatment Group	Vitamin D3	Subjects will receive a Vitamin D3 injection into their wart
Placebo Group	Placebo	Subjects will receive a placebo injection into their wart

Primary Outcome Measures

Name	Time	Method
Complete Regression of Wart	24 weeks	Number of subjects to have a complete resolution of cutaneous wart

Secondary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Mayo Clinic; 🇺🇸 Rochester, Minnesota, United States