Trial Outcomes & Findings for Cryosurgery and Cream Combination for Actinic Keratosis (NCT NCT03037541)
NCT ID: NCT03037541
Last Updated: 2018-08-29
Results Overview
The primary endpoint is number of participants that receive 100% clearance of AK lesions from treatment initiation to end of treatment
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
60 participants
Primary outcome timeframe
24 weeks
Results posted on
2018-08-29
Participant Flow
Participant milestones
| Measure |
Group 1 Carac (Fluorouracil) 0.5% Cream
Carac cream (fluorouracil) 0.5% applied daily on the face for one week
Carac Cream: Carac Cream will be used once daily for seven consecutive days
|
Group 2 Placebo
Placebo Cetaphil cream applied daily on the face for one week
Placebo Cetaphil cream: Placebo Cetaphil Cream will be used once daily for seven consecutive days
|
|---|---|---|
|
Overall Study
STARTED
|
30
|
30
|
|
Overall Study
COMPLETED
|
30
|
30
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Cryosurgery and Cream Combination for Actinic Keratosis
Baseline characteristics by cohort
| Measure |
Group 1 Carac (Fluorouracil) 0.5% Cream
n=30 Participants
Carac cream (fluorouracil) 0.5% applied daily on the face for one week
Carac Cream: Carac Cream will be used once daily for seven consecutive days
|
Group 2 Placebo
n=30 Participants
Placebo Cetaphil cream applied daily on the face for one week
Placebo Cetaphil cream: Placebo Cetaphil Cream will be used once daily for seven consecutive days
|
Total
n=60 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
|
9 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
21 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
43 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
27 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
55 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
30 Participants
n=5 Participants
|
29 Participants
n=7 Participants
|
59 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 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
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 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
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
30 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
60 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
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
30 participants
n=5 Participants
|
30 participants
n=7 Participants
|
60 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 24 weeksThe primary endpoint is number of participants that receive 100% clearance of AK lesions from treatment initiation to end of treatment
Outcome measures
| Measure |
Group 1 Carac (Fluorouracil) 0.5% Cream
n=30 Participants
Carac cream (fluorouracil) 0.5% applied daily on the face for one week
Carac Cream: Carac Cream will be used once daily for seven consecutive days
|
Group 2 Placebo
n=30 Participants
Placebo Cetaphil cream applied daily on the face for one week
Placebo Cetaphil cream: Placebo Cetaphil Cream will be used once daily for seven consecutive days
|
|---|---|---|
|
Number Participants With 100% Clearance
|
12 Participants
|
13 Participants
|
SECONDARY outcome
Timeframe: 24 weeksThe secondary endpoint is number of participants that receive 75 % clearance of
Outcome measures
| Measure |
Group 1 Carac (Fluorouracil) 0.5% Cream
n=30 Participants
Carac cream (fluorouracil) 0.5% applied daily on the face for one week
Carac Cream: Carac Cream will be used once daily for seven consecutive days
|
Group 2 Placebo
n=30 Participants
Placebo Cetaphil cream applied daily on the face for one week
Placebo Cetaphil cream: Placebo Cetaphil Cream will be used once daily for seven consecutive days
|
|---|---|---|
|
Number of Participants With 75% Clearance
|
18 Participants
|
16 Participants
|
Adverse Events
Group 1 Carac (Fluorouracil) 0.5% Cream
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Group 2 Placebo
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Group 1 Carac (Fluorouracil) 0.5% Cream
n=30 participants at risk
Carac cream (fluorouracil) 0.5% applied daily on the face for one week
Carac Cream: Carac Cream will be used once daily for seven consecutive days
|
Group 2 Placebo
n=30 participants at risk
Placebo Cetaphil cream applied daily on the face for one week
Placebo Cetaphil cream: Placebo Cetaphil Cream will be used once daily for seven consecutive days
|
|---|---|---|
|
Skin and subcutaneous tissue disorders
basal cell carcinoma
|
6.7%
2/30 • Number of events 2
|
0.00%
0/30
|
|
Musculoskeletal and connective tissue disorders
joint pain
|
6.7%
2/30 • Number of events 2
|
0.00%
0/30
|
|
Infections and infestations
viral infection
|
0.00%
0/30
|
10.0%
3/30 • Number of events 3
|
|
Infections and infestations
tooth pain
|
0.00%
0/30
|
6.7%
2/30 • Number of events 2
|
Additional Information
Joseph Jorizzo, MD
Wake Forest University Health Sciences
Phone: 336-716-3775
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place