Trial Outcomes & Findings for Cure Rates of Superficial Basal Cell Carcinoma (BCC) EDC (NCT NCT00994240)
NCT ID: NCT00994240
Last Updated: 2015-02-27
Results Overview
Clinical evidence of BCC recurrence post treatment
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
85 participants
Primary outcome timeframe
base line, every 3 months until 12 month completion
Results posted on
2015-02-27
Participant Flow
Participant milestones
| Measure |
ED&C Times 3 Cycles
Electrodessication \& Curettage: Electrodessication \& Curettage 1 or 3 cycles
|
ED & C Times 1 Cycle
Electrodessication \& Curettage: Electrodessication \& Curettage 1 or 3 cycles
|
|---|---|---|
|
Overall Study
STARTED
|
41
|
44
|
|
Overall Study
COMPLETED
|
35
|
39
|
|
Overall Study
NOT COMPLETED
|
6
|
5
|
Reasons for withdrawal
| Measure |
ED&C Times 3 Cycles
Electrodessication \& Curettage: Electrodessication \& Curettage 1 or 3 cycles
|
ED & C Times 1 Cycle
Electrodessication \& Curettage: Electrodessication \& Curettage 1 or 3 cycles
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
3
|
2
|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
|
Overall Study
study termination
|
2
|
3
|
Baseline Characteristics
Cure Rates of Superficial Basal Cell Carcinoma (BCC) EDC
Baseline characteristics by cohort
| Measure |
ED&C Times 3 Cycles
n=41 Participants
Electrodessication \& Curettage: Electrodessication \& Curettage 1 or 3 cycles
|
ED & C Times 1 Cycle
n=44 Participants
Electrodessication \& Curettage: Electrodessication \& Curettage 1 or 3 cycles
|
Total
n=85 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
29 Participants
n=5 Participants
|
32 Participants
n=7 Participants
|
61 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
12 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
24 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
44 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
17 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
41 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
41 participants
n=5 Participants
|
44 participants
n=7 Participants
|
85 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: base line, every 3 months until 12 month completionPopulation: Study was terminated early due to lack of funding and slow enrollment. Biostatisticians determined insufficient data was available for statistical significance. Primary/lead protocol author is no longer at the institution and no data analysis is intended. Study has been closed with the local IRB and study files archived.
Clinical evidence of BCC recurrence post treatment
Outcome measures
| Measure |
ED&C Times 3 Cycles
n=35 Participants
Electrodessication \& Curettage: Electrodessication \& Curettage 1 or 3 cycles
|
ED & C Times 1 Cycle
n=39 Participants
Electrodessication \& Curettage: Electrodessication \& Curettage 1 or 3 cycles
|
|---|---|---|
|
Difference in Cure Rates of Superficial BCC Following One Cycle of ED&C Versus Three Cycles of ED&C.
|
1 participants
|
0 participants
|
Adverse Events
ED&C Times 3 Cycles
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
ED & C Times 1 Cycle
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
ED&C Times 3 Cycles
n=41 participants at risk
Electrodessication \& Curettage: Electrodessication \& Curettage 1 or 3 cycles
|
ED & C Times 1 Cycle
n=44 participants at risk
Electrodessication \& Curettage: Electrodessication \& Curettage 1 or 3 cycles
|
|---|---|---|
|
Skin and subcutaneous tissue disorders
itching
|
12.2%
5/41 • Number of events 5
|
15.9%
7/44 • Number of events 7
|
|
Skin and subcutaneous tissue disorders
infection
|
4.9%
2/41 • Number of events 2
|
0.00%
0/44
|
Additional Information
Clinical Research Administrator
University of Wisconsin-Madison
Phone: 608-287-2640
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place