Trial Outcomes & Findings for Treatment of External Genital Warts With Cryotherapy and Sinecatechins 15% Ointment (NCT NCT02147353)
NCT ID: NCT02147353
Last Updated: 2019-06-14
Results Overview
Subjects with complete clearance, or no longer have HPV infected cells. Complete clearance was defined as zero lesions at the respective time points.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
42 participants
Primary outcome timeframe
at week 1, week 9, and week 17
Results posted on
2019-06-14
Participant Flow
All patients were enrolled from September 2011 to December 2012.
Participant milestones
| Measure |
Sinecatechins 15% Ointment & Cryotherapy
Cryotherapy and then Sinecatechins 15% Ointment 1 week later.
Sinecatechins 15% Ointment: Following cryotherapy, half of the subjects randomized to treatment with sinecatechins ointment twice daily starting one week after cryotherapy up to 16 weeks or until complete clearance.
|
Cryotherapy Alone
Cryotherapy standardized in all subjects and for all treated lesions: EGW lesions treated with 2 cycles, 5 seconds each, with a 5 second interval. All subjects treated with the same cryo-spray regimen.
|
|---|---|---|
|
Overall Study
STARTED
|
21
|
21
|
|
Overall Study
COMPLETED
|
12
|
21
|
|
Overall Study
NOT COMPLETED
|
9
|
0
|
Reasons for withdrawal
| Measure |
Sinecatechins 15% Ointment & Cryotherapy
Cryotherapy and then Sinecatechins 15% Ointment 1 week later.
Sinecatechins 15% Ointment: Following cryotherapy, half of the subjects randomized to treatment with sinecatechins ointment twice daily starting one week after cryotherapy up to 16 weeks or until complete clearance.
|
Cryotherapy Alone
Cryotherapy standardized in all subjects and for all treated lesions: EGW lesions treated with 2 cycles, 5 seconds each, with a 5 second interval. All subjects treated with the same cryo-spray regimen.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
2
|
0
|
|
Overall Study
unable to make visits
|
4
|
0
|
|
Overall Study
medication noncompliance
|
3
|
0
|
Baseline Characteristics
Treatment of External Genital Warts With Cryotherapy and Sinecatechins 15% Ointment
Baseline characteristics by cohort
| Measure |
Sinecatechins 15% Ointment and Cryotherapy
n=21 Participants
Sinecatechins 15% Ointment: Following cryotherapy, half of the subjects randomized to treatment with sinecatechins ointment twice daily starting one week after cryotherapy up to 16 weeks or until complete clearance.
|
Cryotherapy Alone
n=21 Participants
Cryotherapy standardized in all subjects and for all treated lesions: EGW lesions treated with 2 cycles, 5 seconds each, with a 5 second interval. All subjects treated with the same cryo-spray regimen.
|
Total
n=42 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
38.8 years
STANDARD_DEVIATION 5.2 • n=93 Participants
|
35.8 years
STANDARD_DEVIATION 4.4 • n=4 Participants
|
37.3 years
STANDARD_DEVIATION 4.8 • n=27 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=93 Participants
|
3 Participants
n=4 Participants
|
7 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
17 Participants
n=93 Participants
|
18 Participants
n=4 Participants
|
35 Participants
n=27 Participants
|
PRIMARY outcome
Timeframe: at week 1, week 9, and week 17Subjects with complete clearance, or no longer have HPV infected cells. Complete clearance was defined as zero lesions at the respective time points.
Outcome measures
| Measure |
Sinecatechins 15% Ointment & Cryotherapy
n=21 Participants
Cryotherapy and then Sinecatechins 15% Ointment 1 week later.
Sinecatechins 15% Ointment: Following cryotherapy, half of the subjects randomized to treatment with sinecatechins ointment twice daily starting one week after cryotherapy up to 16 weeks or until complete clearance.
|
Cryotherapy Alone
n=21 Participants
Cryotherapy standardized in all subjects and for all treated lesions: EGW lesions treated with 2 cycles, 5 seconds each, with a 5 second interval. All subjects treated with the same cryo-spray regimen.
|
|---|---|---|
|
Number of Participants With Complete Clearance,
at week 9
|
3 participants
|
5 participants
|
|
Number of Participants With Complete Clearance,
at week 17
|
6 participants
|
6 participants
|
|
Number of Participants With Complete Clearance,
at week 1
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: at 24 week post-treatment periodTo evaluate the efficacy of using combination cryotherapy-sinecatechins 15% ointment BID versus cryotherapy alone on EGW lesions via recurrence rates of previously treated EGW lesions in those subjects who achieved a complete response over a 24 week post-treatment period.
Outcome measures
| Measure |
Sinecatechins 15% Ointment & Cryotherapy
n=21 Participants
Cryotherapy and then Sinecatechins 15% Ointment 1 week later.
Sinecatechins 15% Ointment: Following cryotherapy, half of the subjects randomized to treatment with sinecatechins ointment twice daily starting one week after cryotherapy up to 16 weeks or until complete clearance.
|
Cryotherapy Alone
n=21 Participants
Cryotherapy standardized in all subjects and for all treated lesions: EGW lesions treated with 2 cycles, 5 seconds each, with a 5 second interval. All subjects treated with the same cryo-spray regimen.
|
|---|---|---|
|
Number of Participants With Recurrence of Previously Treated EGW Lesions
|
1 Participants
|
5 Participants
|
SECONDARY outcome
Timeframe: at 48 week post-treatment periodTo evaluate the efficacy of using combination cryotherapy-sinecatechins 15% ointment BID versus cryotherapy alone on EGW lesions via recurrence rates of previously treated EGW lesions in those subjects who achieved a complete response over a 48 week post-treatment period.
Outcome measures
| Measure |
Sinecatechins 15% Ointment & Cryotherapy
n=21 Participants
Cryotherapy and then Sinecatechins 15% Ointment 1 week later.
Sinecatechins 15% Ointment: Following cryotherapy, half of the subjects randomized to treatment with sinecatechins ointment twice daily starting one week after cryotherapy up to 16 weeks or until complete clearance.
|
Cryotherapy Alone
n=21 Participants
Cryotherapy standardized in all subjects and for all treated lesions: EGW lesions treated with 2 cycles, 5 seconds each, with a 5 second interval. All subjects treated with the same cryo-spray regimen.
|
|---|---|---|
|
Number of Participants With Recurrence of Previously Treated EGW Lesions
|
2 Participants
|
6 Participants
|
SECONDARY outcome
Timeframe: at 16 week treatment periodTo evaluate the safety of cryotherapy-sinecatechins 15% ointment BID versus cryotherapy alone as a regimen for EGW by evaluating for local skin reactions and adverse events. Number of participants with local skin reactions.
Outcome measures
| Measure |
Sinecatechins 15% Ointment & Cryotherapy
n=21 Participants
Cryotherapy and then Sinecatechins 15% Ointment 1 week later.
Sinecatechins 15% Ointment: Following cryotherapy, half of the subjects randomized to treatment with sinecatechins ointment twice daily starting one week after cryotherapy up to 16 weeks or until complete clearance.
|
Cryotherapy Alone
n=21 Participants
Cryotherapy standardized in all subjects and for all treated lesions: EGW lesions treated with 2 cycles, 5 seconds each, with a 5 second interval. All subjects treated with the same cryo-spray regimen.
|
|---|---|---|
|
Local Skin Reactions
|
21 Participants
|
21 Participants
|
SECONDARY outcome
Timeframe: At week 1, week 9, and week 17Partial clearance is described as at least 50% reduction from baseline
Outcome measures
| Measure |
Sinecatechins 15% Ointment & Cryotherapy
n=21 Participants
Cryotherapy and then Sinecatechins 15% Ointment 1 week later.
Sinecatechins 15% Ointment: Following cryotherapy, half of the subjects randomized to treatment with sinecatechins ointment twice daily starting one week after cryotherapy up to 16 weeks or until complete clearance.
|
Cryotherapy Alone
n=21 Participants
Cryotherapy standardized in all subjects and for all treated lesions: EGW lesions treated with 2 cycles, 5 seconds each, with a 5 second interval. All subjects treated with the same cryo-spray regimen.
|
|---|---|---|
|
Subjects With Partial Clearance of Lesions
at week 1
|
7 participants
|
6 participants
|
|
Subjects With Partial Clearance of Lesions
at week 9
|
15 participants
|
9 participants
|
|
Subjects With Partial Clearance of Lesions
at week 17
|
15 participants
|
11 participants
|
SECONDARY outcome
Timeframe: Week 1, week 9 and week 17Population: data for only those participants who returned for the respective visits.
Mean change in number of lesions after 1 weeks, 9 weeks and 17 weeks post treatment as compared to baseline
Outcome measures
| Measure |
Sinecatechins 15% Ointment & Cryotherapy
n=21 Participants
Cryotherapy and then Sinecatechins 15% Ointment 1 week later.
Sinecatechins 15% Ointment: Following cryotherapy, half of the subjects randomized to treatment with sinecatechins ointment twice daily starting one week after cryotherapy up to 16 weeks or until complete clearance.
|
Cryotherapy Alone
n=21 Participants
Cryotherapy standardized in all subjects and for all treated lesions: EGW lesions treated with 2 cycles, 5 seconds each, with a 5 second interval. All subjects treated with the same cryo-spray regimen.
|
|---|---|---|
|
Mean Change in Number of Lesions
Week 1
|
-2.2 number of lesions
Standard Deviation 3.93
|
-2.1 number of lesions
Standard Deviation 3.83
|
|
Mean Change in Number of Lesions
Week 9
|
-5.4 number of lesions
Standard Deviation 5.71
|
-2.7 number of lesions
Standard Deviation 3.68
|
|
Mean Change in Number of Lesions
Week 17
|
-4.8 number of lesions
Standard Deviation 7.87
|
-3.8 number of lesions
Standard Deviation 5.49
|
SECONDARY outcome
Timeframe: At week 1, week 9, and week 17Mean change in number of lesions as compared to baseline at Week 1, Week 9 and Week 17 for the intent-to-treat population
Outcome measures
| Measure |
Sinecatechins 15% Ointment & Cryotherapy
n=21 Participants
Cryotherapy and then Sinecatechins 15% Ointment 1 week later.
Sinecatechins 15% Ointment: Following cryotherapy, half of the subjects randomized to treatment with sinecatechins ointment twice daily starting one week after cryotherapy up to 16 weeks or until complete clearance.
|
Cryotherapy Alone
n=21 Participants
Cryotherapy standardized in all subjects and for all treated lesions: EGW lesions treated with 2 cycles, 5 seconds each, with a 5 second interval. All subjects treated with the same cryo-spray regimen.
|
|---|---|---|
|
Mean Change in Number of Lesions
Week 1
|
-2.2 lesions
Standard Deviation 3.93
|
-2.1 lesions
Standard Deviation 3.83
|
|
Mean Change in Number of Lesions
Week 9
|
-5.0 lesions
Standard Deviation 5.74
|
-2.1 lesions
Standard Deviation 3.75
|
|
Mean Change in Number of Lesions
Week 17
|
-5.0 lesions
Standard Deviation 6.90
|
-2.1 lesions
Standard Deviation 4.73
|
Adverse Events
Sinecatechins 15% Ointment & Cryotherapy
Serious events: 0 serious events
Other events: 21 other events
Deaths: 0 deaths
Cryotherapy Alone
Serious events: 0 serious events
Other events: 21 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Sinecatechins 15% Ointment & Cryotherapy
n=21 participants at risk
Cryotherapy and then Sinecatechins 15% Ointment 1 week later.
Sinecatechins 15% Ointment: Following cryotherapy, half of the subjects randomized to treatment with sinecatechins ointment twice daily starting one week after cryotherapy up to 16 weeks or until complete clearance.
|
Cryotherapy Alone
n=21 participants at risk
Cryotherapy standardized in all subjects and for all treated lesions: EGW lesions treated with 2 cycles, 5 seconds each, with a 5 second interval. All subjects treated with the same cryo-spray regimen.
|
|---|---|---|
|
Skin and subcutaneous tissue disorders
local site reactions
|
100.0%
21/21 • Number of events 21 • Adverse event data were collected over 65 weeks
There were no serious adverse events related to the study medication reported during the study. All subjects experienced mild to moderate local site reactions (eg, any symptom of erythema, edema, scaling, crusting, and erosion which were not collected separately) that were related to both cryotherapy and/or sinecatechins ointment. There were no subject discontinuations or dose interruptions.
|
100.0%
21/21 • Number of events 21 • Adverse event data were collected over 65 weeks
There were no serious adverse events related to the study medication reported during the study. All subjects experienced mild to moderate local site reactions (eg, any symptom of erythema, edema, scaling, crusting, and erosion which were not collected separately) that were related to both cryotherapy and/or sinecatechins ointment. There were no subject discontinuations or dose interruptions.
|
Additional Information
Dr. Shelbi C. Jim On
Icahn School of Medicine at Mount Sinai
Phone: 212-241-6500
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place