Trial Outcomes & Findings for A Phase I/II Double-blind Safety and Efficacy Evaluation of Nowarta110 in Patients With Plantar Warts (NCT NCT02338336)

NCT ID: NCT02338336

Last Updated: 2016-11-04

Results Overview

Lesion (plantar wart) size measured in millimeters. Measurement of the longest dimension was recorded. Observed data

• Recruitment status: COMPLETED
• Study phase: PHASE1/PHASE2
• Target enrollment: 54 participants
• Primary outcome timeframe: 6 weeks
• Results posted on: 2016-11-04

Participant Flow

Recruited at a single center

Random assignment was stratified by the size of the plantar wart: If the lesion size was less than 1 cm2, 3 drops were applied once weekly for 5 weeks If the lesion size was between 1 cm2 and 2 cm2, 6 drops were applied once weekly for 5 weeks If the lesion size was larger than 2 cm2, 10 drops were applied once weekly for 5 weeks

Participant milestones

Measure	Placebo Matching Placebo	Norwarta110 3 Drops Nowarta110 3 drops administered topically	Nowarta110 6 Drops Nowarta110 6 drops administered topically	Nowarta110 10 Drops Nowarta110 10 drops administered topically
Overall Study STARTED	26	17	7	4
Overall Study COMPLETED	24	17	7	4
Overall Study NOT COMPLETED	2	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Phase I/II Double-blind Safety and Efficacy Evaluation of Nowarta110 in Patients With Plantar Warts

Baseline characteristics by cohort

Measure	Placebo n=26 Participants Matching Placebo	Nowarta110 n=28 Participants All combined Nowarta110 doses	Total n=54 Participants Total of all reporting groups
Age, Continuous	34.0 years STANDARD_DEVIATION 10.58 • n=5 Participants	34.5 years STANDARD_DEVIATION 12.65 • n=7 Participants	34.3 years STANDARD_DEVIATION 11.59 • n=5 Participants
Sex: Female, Male Female	12 Participants n=5 Participants	17 Participants n=7 Participants	29 Participants n=5 Participants
Sex: Female, Male Male	14 Participants n=5 Participants	11 Participants n=7 Participants	25 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	4 Participants n=5 Participants	1 Participants n=7 Participants	5 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	3 Participants n=5 Participants	4 Participants n=7 Participants	7 Participants n=5 Participants
Race (NIH/OMB) White	18 Participants n=5 Participants	22 Participants n=7 Participants	40 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants

PRIMARY outcome

Timeframe: 6 weeks

Population: Intent-to-treat

Lesion (plantar wart) size measured in millimeters. Measurement of the longest dimension was recorded. Observed data

Outcome measures

Measure	Placebo n=26 Participants Matching Placebo	TREATMENT n=28 Participants Nowarta110
Lesion Assessment Baseline	8.42 millimeters Standard Deviation 7.229	9.14 millimeters Standard Deviation 6.072
Lesion Assessment Week 1	8.42 millimeters Standard Deviation 7.229	8.71 millimeters Standard Deviation 5.843
Lesion Assessment Week 2	7.92 millimeters Standard Deviation 7.227	7.36 millimeters Standard Deviation 5.864
Lesion Assessment Week 3	7.85 millimeters Standard Deviation 7.182	6.00 millimeters Standard Deviation 4.974
Lesion Assessment Week 4	7.58 millimeters Standard Deviation 7.300	4.86 millimeters Standard Deviation 4.411
Lesion Assessment Week 5	7.38 millimeters Standard Deviation 7.149	3.61 millimeters Standard Deviation 4.076
Lesion Assessment Week 6	7.13 millimeters Standard Deviation 7.267	2.25 millimeters Standard Deviation 4.334

PRIMARY outcome

Timeframe: 6 weeks

Population: ITT

Percent of participants with lesion measurement either equal to 0 or greater than 0

Outcome measures

Measure	Placebo n=26 Participants Matching Placebo	TREATMENT n=28 Participants Nowarta110
Incidence of Zero Lesion Measurement Lesion Measurement = 0	7.7 percentage of participants	64.3 percentage of participants
Incidence of Zero Lesion Measurement Lesion Measurment > 0	84.6 percentage of participants	35.7 percentage of participants

Adverse Events

Placebo

Serious events: 0 serious events

Other events: 9 other events

Deaths: 0 deaths

Nowarta110

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Placebo n=26 participants at risk Matching Placebo	Nowarta110 n=28 participants at risk All combined Nowarta110 doses
Skin and subcutaneous tissue disorders Burning/stinging	34.6% 9/26 • Number of events 9 • 6 weeks	0.00% 0/28 • 6 weeks
Skin and subcutaneous tissue disorders Dryness	7.7% 2/26 • Number of events 2 • 6 weeks	0.00% 0/28 • 6 weeks
Skin and subcutaneous tissue disorders Edema	3.8% 1/26 • Number of events 1 • 6 weeks	0.00% 0/28 • 6 weeks
Skin and subcutaneous tissue disorders Itching	3.8% 1/26 • Number of events 1 • 6 weeks	0.00% 0/28 • 6 weeks
Skin and subcutaneous tissue disorders Pain	7.7% 2/26 • Number of events 2 • 6 weeks	3.6% 1/28 • Number of events 1 • 6 weeks

Additional Information

Peggy Hagerty

Norwarta

Phone: 267-240-4010

Email: hagertymws@comcast.net

Results disclosure agreements

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