Trial Outcomes & Findings for Intralesional Vitamin D Injection for Treatment of Common Warts (NCT NCT04278573)

NCT ID: NCT04278573

Last Updated: 2024-04-30

Results Overview

Number of subjects to have a complete resolution of cutaneous wart

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 77 participants
• Primary outcome timeframe: 24 weeks
• Results posted on: 2024-04-30

Participant Flow

Participant milestones

Measure	Vitamin D3 Treatment Group Subjects will receive a Vitamin D3 injection into their wart Vitamin D3: 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 Placebo: 0.3 ml injection of sterilized sesame oil with no active study ingredient
Overall Study STARTED	41	36
Overall Study COMPLETED	41	36
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Intralesional Vitamin D Injection for Treatment of Common Warts

Baseline characteristics by cohort

Measure	Vitamin D3 Treatment Group n=41 Participants Subjects will receive a Vitamin D3 injection into their wart Vitamin D3: Intralesional injection of 0.3 ml 40,000 IU/ml vitamin D3 into one wart	Placebo Group n=36 Participants Subjects will receive a placebo injection into their wart Placebo: 0.3 ml injection of sterilized sesame oil with no active study ingredient	Total n=77 Participants Total of all reporting groups
Age, Continuous	36.7 years STANDARD_DEVIATION 11.0 • n=93 Participants	33.6 years STANDARD_DEVIATION 10.1 • n=4 Participants	35.3 years STANDARD_DEVIATION 10.6 • n=27 Participants
Sex: Female, Male Female	32 Participants n=93 Participants	26 Participants n=4 Participants	58 Participants n=27 Participants
Sex: Female, Male Male	9 Participants n=93 Participants	10 Participants n=4 Participants	19 Participants n=27 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=93 Participants	2 Participants n=4 Participants	2 Participants n=27 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	41 Participants n=93 Participants	34 Participants n=4 Participants	75 Participants n=27 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Asian	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Black or African American	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) White	41 Participants n=93 Participants	36 Participants n=4 Participants	77 Participants n=27 Participants
Race (NIH/OMB) More than one race	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Region of Enrollment United States	41 participants n=93 Participants	36 participants n=4 Participants	77 participants n=27 Participants

PRIMARY outcome

Timeframe: 24 weeks

Number of subjects to have a complete resolution of cutaneous wart

Outcome measures

Measure	Vitamin D3 Treatment Group n=41 Participants Subjects will receive a Vitamin D3 injection into their wart Vitamin D3: Intralesional injection of 0.3 ml 40,000 IU/ml vitamin D3 into one wart	Placebo Group n=36 Participants Subjects will receive a placebo injection into their wart Placebo: 0.3 ml injection of sterilized sesame oil with no active study ingredient
Complete Regression of Wart	12 Participants	10 Participants

SECONDARY outcome

Timeframe: 4 weeks

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

Outcome measures

Measure	Vitamin D3 Treatment Group n=41 Participants Subjects will receive a Vitamin D3 injection into their wart Vitamin D3: Intralesional injection of 0.3 ml 40,000 IU/ml vitamin D3 into one wart	Placebo Group n=36 Participants Subjects will receive a placebo injection into their wart Placebo: 0.3 ml injection of sterilized sesame oil with no active study ingredient
Regression of Wart at 4 Weeks	2 Participants	2 Participants

SECONDARY outcome

Timeframe: 8 weeks

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

Outcome measures

Measure	Vitamin D3 Treatment Group n=41 Participants Subjects will receive a Vitamin D3 injection into their wart Vitamin D3: Intralesional injection of 0.3 ml 40,000 IU/ml vitamin D3 into one wart	Placebo Group n=36 Participants Subjects will receive a placebo injection into their wart Placebo: 0.3 ml injection of sterilized sesame oil with no active study ingredient
Regression of Wart at 8 Weeks	4 Participants	7 Participants

SECONDARY outcome

Timeframe: 12 weeks

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

Outcome measures

Measure	Vitamin D3 Treatment Group n=41 Participants Subjects will receive a Vitamin D3 injection into their wart Vitamin D3: Intralesional injection of 0.3 ml 40,000 IU/ml vitamin D3 into one wart	Placebo Group n=36 Participants Subjects will receive a placebo injection into their wart Placebo: 0.3 ml injection of sterilized sesame oil with no active study ingredient
Regression of Wart at 12 Weeks	7 Participants	8 Participants

Adverse Events

Vitamin D3 Treatment Group

Serious events: 0 serious events

Other events: 41 other events

Deaths: 0 deaths

Placebo Group

Serious events: 0 serious events

Other events: 36 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Vitamin D3 Treatment Group n=41 participants at risk Subjects will receive a Vitamin D3 injection into their wart Vitamin D3: Intralesional injection of 0.3 ml 40,000 IU/ml vitamin D3 into one wart	Placebo Group n=36 participants at risk Subjects will receive a placebo injection into their wart Placebo: 0.3 ml injection of sterilized sesame oil with no active study ingredient
General disorders Skin redness at injection site	36.6% 15/41 • Number of events 15 • 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.	41.7% 15/36 • Number of events 15 • 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.
General disorders Itching	46.3% 19/41 • Number of events 19 • 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.	52.8% 19/36 • Number of events 19 • 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.
General disorders Hematoma (blood blister)	17.1% 7/41 • Number of events 7 • 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.	5.6% 2/36 • Number of events 2 • 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.

Additional Information

Dr. Stephen P. Merry

Mayo Clinic

Phone: 507-284-5180

Email: merry.stephen@mayo.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place