Trial Outcomes & Findings for Investigating Veregen ™ 15% Ointment Treatment For Non-facial Verrucae in Pediatric Patients: A Pilot Study (NCT NCT02622568)
NCT ID: NCT02622568
Last Updated: 2017-09-08
Results Overview
Diameter of verrucae (warts) at week 12
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
28 participants
Primary outcome timeframe
12 weeks
Results posted on
2017-09-08
Participant Flow
Pediatric Dermatology Medical Clinic
Participant milestones
| Measure |
Cryotherapy + Veregen
Cryotherapy will be performed on the day of first clinic visit according to current standard of care in Children's Medical Center pediatric outpatient dermatology clinic, which consists of two freeze/thaw cycles for maximum of 10 seconds each. Veregen ™ 15% ointment will be prescribed and initiated immediately following the day of first clinic visit. Veregen ™ 15% ointment will be applied to verrucous lesions twice daily per current Children's Medical Center protocol. Follow-up clinical visits will be required at 0 weeks, 6 weeks, and 12 weeks. The first day of treatment will begin on the day of first clinic visit (0 weeks). Clinical photos will be taken at each visit. Verrucae will be measured at each visit using a standard ruler. Outcome measures will be numerical reduction in diameter of verruca.
Veregen or Sinecatechins
|
Veregen Only
Veregen ™ 15% ointment will be prescribed and initiated immediately following the day of first clinic visit. Veregen ™ 15% ointment will be applied to verrucous lesions twice daily per current Children's Medical Center protocol. Follow-up clinical visits will be required at 0 weeks, 6 weeks, and 12 weeks. The first day of treatment will begin on the day of first clinic visit (0 weeks). Clinical photos will be taken at each visit. Verrucae will be measured at each visit using a standard ruler. Outcome measures will be numerical reduction in diameter of verruca.
Veregen or Sinecatechins
|
|---|---|---|
|
Overall Study
STARTED
|
14
|
14
|
|
Overall Study
COMPLETED
|
9
|
9
|
|
Overall Study
NOT COMPLETED
|
5
|
5
|
Reasons for withdrawal
| Measure |
Cryotherapy + Veregen
Cryotherapy will be performed on the day of first clinic visit according to current standard of care in Children's Medical Center pediatric outpatient dermatology clinic, which consists of two freeze/thaw cycles for maximum of 10 seconds each. Veregen ™ 15% ointment will be prescribed and initiated immediately following the day of first clinic visit. Veregen ™ 15% ointment will be applied to verrucous lesions twice daily per current Children's Medical Center protocol. Follow-up clinical visits will be required at 0 weeks, 6 weeks, and 12 weeks. The first day of treatment will begin on the day of first clinic visit (0 weeks). Clinical photos will be taken at each visit. Verrucae will be measured at each visit using a standard ruler. Outcome measures will be numerical reduction in diameter of verruca.
Veregen or Sinecatechins
|
Veregen Only
Veregen ™ 15% ointment will be prescribed and initiated immediately following the day of first clinic visit. Veregen ™ 15% ointment will be applied to verrucous lesions twice daily per current Children's Medical Center protocol. Follow-up clinical visits will be required at 0 weeks, 6 weeks, and 12 weeks. The first day of treatment will begin on the day of first clinic visit (0 weeks). Clinical photos will be taken at each visit. Verrucae will be measured at each visit using a standard ruler. Outcome measures will be numerical reduction in diameter of verruca.
Veregen or Sinecatechins
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
5
|
5
|
Baseline Characteristics
Analysis limited to participants that completed the study
Baseline characteristics by cohort
| Measure |
Cryotherapy + Veregen
n=14 Participants
Cryotherapy will be performed on the day of first clinic visit according to current standard of care in Children's Medical Center pediatric outpatient dermatology clinic, which consists of two freeze/thaw cycles for maximum of 10 seconds each. Veregen ™ 15% ointment will be prescribed and initiated immediately following the day of first clinic visit. Veregen ™ 15% ointment will be applied to verrucous lesions twice daily per current Children's Medical Center protocol. Follow-up clinical visits will be required at 0 weeks, 6 weeks, and 12 weeks. The first day of treatment will begin on the day of first clinic visit (0 weeks). Clinical photos will be taken at each visit. Verrucae will be measured at each visit using a standard ruler. Outcome measures will be numerical reduction in diameter of verruca.
Veregen or Sinecatechins + cryotherapy
|
Veregen Only
n=14 Participants
Veregen ™ 15% ointment will be prescribed and initiated immediately following the day of first clinic visit. Veregen ™ 15% ointment will be applied to verrucous lesions twice daily per current Children's Medical Center protocol. Follow-up clinical visits will be required at 0 weeks, 6 weeks, and 12 weeks. The first day of treatment will begin on the day of first clinic visit (0 weeks). Clinical photos will be taken at each visit. Verrucae will be measured at each visit using a standard ruler. Outcome measures will be numerical reduction in diameter of verruca.
Veregen or Sinecatechins
|
Total
n=28 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
14 Participants
n=14 Participants
|
14 Participants
n=14 Participants
|
28 Participants
n=28 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=14 Participants
|
0 Participants
n=14 Participants
|
0 Participants
n=28 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=14 Participants
|
0 Participants
n=14 Participants
|
0 Participants
n=28 Participants
|
|
Age, Continuous
|
9.1 years
STANDARD_DEVIATION 3.14 • n=14 Participants
|
10.1 years
STANDARD_DEVIATION 2.47 • n=14 Participants
|
9.6 years
STANDARD_DEVIATION 2.79 • n=28 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=9 Participants • Analysis limited to participants that completed the study
|
5 Participants
n=9 Participants • Analysis limited to participants that completed the study
|
8 Participants
n=18 Participants • Analysis limited to participants that completed the study
|
|
Sex: Female, Male
Male
|
6 Participants
n=9 Participants • Analysis limited to participants that completed the study
|
4 Participants
n=9 Participants • Analysis limited to participants that completed the study
|
10 Participants
n=18 Participants • Analysis limited to participants that completed the study
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United States
|
14 participants
n=14 Participants
|
14 participants
n=14 Participants
|
28 participants
n=28 Participants
|
|
Diameter of verrucae at presentation
|
6.444 mm
STANDARD_DEVIATION 1.9437 • n=9 Participants • Only participants completing study are included in analysis.
|
6.222 mm
STANDARD_DEVIATION 1.922 • n=9 Participants • Only participants completing study are included in analysis.
|
6.3 mm
STANDARD_DEVIATION 1.88 • n=18 Participants • Only participants completing study are included in analysis.
|
PRIMARY outcome
Timeframe: 12 weeksPopulation: Only participants completing study are included in analysis.
Diameter of verrucae (warts) at week 12
Outcome measures
| Measure |
Cryotherapy + Veregen
n=9 Participants
Cryotherapy will be performed on the day of first clinic visit according to current standard of care in Children's Medical Center pediatric outpatient dermatology clinic, which consists of two freeze/thaw cycles for maximum of 10 seconds each. Veregen ™ 15% ointment will be prescribed and initiated immediately following the day of first clinic visit. Veregen ™ 15% ointment will be applied to verrucous lesions twice daily per current Children's Medical Center protocol. Follow-up clinical visits will be required at 0 weeks, 6 weeks, and 12 weeks. The first day of treatment will begin on the day of first clinic visit (0 weeks). Clinical photos will be taken at each visit. Verrucae will be measured at each visit using a standard ruler. Outcome measures will be numerical reduction in diameter of verruca.
Veregen or Sinecatechins following cryotherapy
|
Veregen Only
n=9 Participants
Veregen ™ 15% ointment will be prescribed and initiated immediately following the day of first clinic visit. Veregen ™ 15% ointment will be applied to verrucous lesions twice daily per current Children's Medical Center protocol. Follow-up clinical visits will be required at 0 weeks, 6 weeks, and 12 weeks. The first day of treatment will begin on the day of first clinic visit (0 weeks). Clinical photos will be taken at each visit. Verrucae will be measured at each visit using a standard ruler. Outcome measures will be numerical reduction in diameter of verruca.
Veregen or Sinecatechins
|
|---|---|---|
|
Size of Verrucae (Warts)
|
2.333 millimeters
Standard Deviation 3.3541
|
3.889 millimeters
Standard Deviation 3.9826
|
Adverse Events
Cryotherapy + Veregen
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Veregen Only
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 |
Cryotherapy + Veregen
n=14 participants at risk
Cryotherapy will be performed on the day of first clinic visit according to current standard of care in Children's Medical Center pediatric outpatient dermatology clinic, which consists of two freeze/thaw cycles for maximum of 10 seconds each. Veregen ™ 15% ointment will be prescribed and initiated immediately following the day of first clinic visit. Veregen ™ 15% ointment will be applied to verrucous lesions twice daily per current Children's Medical Center protocol. Follow-up clinical visits will be required at 0 weeks, 6 weeks, and 12 weeks. The first day of treatment will begin on the day of first clinic visit (0 weeks). Clinical photos will be taken at each visit. Verrucae will be measured at each visit using a standard ruler. Outcome measures will be numerical reduction in diameter of verruca.
Veregen or Sinecatechins
|
Veregen Only
n=14 participants at risk
Veregen ™ 15% ointment will be prescribed and initiated immediately following the day of first clinic visit. Veregen ™ 15% ointment will be applied to verrucous lesions twice daily per current Children's Medical Center protocol. Follow-up clinical visits will be required at 0 weeks, 6 weeks, and 12 weeks. The first day of treatment will begin on the day of first clinic visit (0 weeks). Clinical photos will be taken at each visit. Verrucae will be measured at each visit using a standard ruler. Outcome measures will be numerical reduction in diameter of verruca.
Veregen or Sinecatechins
|
|---|---|---|
|
Skin and subcutaneous tissue disorders
Minor irritation
|
7.1%
1/14 • Number of events 1 • 12 weeks
|
7.1%
1/14 • Number of events 1 • 12 weeks
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place