Intralesional Vitamin D Injection for Treatment of Common Warts

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

77 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-10-20

Study Completion Date

2023-04-04

Brief Summary

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

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Detailed Description

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Conditions

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Warts

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Vitamin D3 Treatment Group

Subjects will receive a Vitamin D3 injection into their wart

Group Type EXPERIMENTAL

Vitamin D3

Intervention Type DRUG

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

Placebo Group

Subjects will receive a placebo injection into their wart

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

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

Interventions

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Vitamin D3

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

Intervention Type DRUG

Placebo

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

Intervention Type DRUG

Other Intervention Names

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Cholecalciferol

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No