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Cryosurgery and Cream Combination for Actinic Keratosis

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ClinicalTrials.gov Identifier: NCT03037541
Recruitment Status : Completed
First Posted : January 31, 2017
Results First Posted : March 23, 2017
Last Update Posted : August 29, 2018
Sponsor:
Information provided by (Responsible Party):
Wake Forest University Health Sciences

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Investigator);   Primary Purpose: Treatment
Condition Actinic Keratosis
Interventions Drug: Carac Cream
Drug: Placebo Cetaphil cream
Enrollment 60
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Group 1 Carac (Fluorouracil) 0.5% Cream Group 2 Placebo
Hide Arm/Group Description

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

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

Period Title: Overall Study
Started 30 30
Completed 30 30
Not Completed 0 0
Arm/Group Title Group 1 Carac (Fluorouracil) 0.5% Cream Group 2 Placebo Total
Hide Arm/Group Description

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

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 of all reporting groups
Overall Number of Baseline Participants 30 30 60
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 30 participants 30 participants 60 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
9
  30.0%
8
  26.7%
17
  28.3%
>=65 years
21
  70.0%
22
  73.3%
43
  71.7%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 30 participants 30 participants 60 participants
Female
3
  10.0%
2
   6.7%
5
   8.3%
Male
27
  90.0%
28
  93.3%
55
  91.7%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 30 participants 30 participants 60 participants
Hispanic or Latino
0
   0.0%
1
   3.3%
1
   1.7%
Not Hispanic or Latino
30
 100.0%
29
  96.7%
59
  98.3%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 30 participants 30 participants 60 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
0
   0.0%
0
   0.0%
0
   0.0%
White
30
 100.0%
30
 100.0%
60
 100.0%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 30 participants 30 participants 60 participants
30 30 60
1.Primary Outcome
Title Number Participants With 100% Clearance
Hide Description The primary endpoint is number of participants that receive 100% clearance of AK lesions from treatment initiation to end of treatment
Time Frame 24 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Group 1 Carac (Fluorouracil) 0.5% Cream Group 2 Placebo
Hide Arm/Group Description:

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

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 Number of Participants Analyzed 30 30
Measure Type: Count of Participants
Unit of Measure: Participants
12
  40.0%
13
  43.3%
2.Secondary Outcome
Title Number of Participants With 75% Clearance
Hide Description The secondary endpoint is number of participants that receive 75 % clearance of
Time Frame 24 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Group 1 Carac (Fluorouracil) 0.5% Cream Group 2 Placebo
Hide Arm/Group Description:

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

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 Number of Participants Analyzed 30 30
Measure Type: Count of Participants
Unit of Measure: Participants
18
  60.0%
16
  53.3%
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Group 1 Carac (Fluorouracil) 0.5% Cream Group 2 Placebo
Hide Arm/Group Description

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

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

All-Cause Mortality
Group 1 Carac (Fluorouracil) 0.5% Cream Group 2 Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/30 (0.00%)      0/30 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
Group 1 Carac (Fluorouracil) 0.5% Cream Group 2 Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/30 (0.00%)      0/30 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Group 1 Carac (Fluorouracil) 0.5% Cream Group 2 Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   4/30 (13.33%)      5/30 (16.67%)    
Infections and infestations     
viral infection *  0/30 (0.00%)  0 3/30 (10.00%)  3
tooth pain *  0/30 (0.00%)  0 2/30 (6.67%)  2
Musculoskeletal and connective tissue disorders     
joint pain *  2/30 (6.67%)  2 0/30 (0.00%)  0
Skin and subcutaneous tissue disorders     
basal cell carcinoma *  2/30 (6.67%)  2 0/30 (0.00%)  0
*
Indicates events were collected by non-systematic assessment
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Joseph Jorizzo, MD
Organization: Wake Forest University Health Sciences
Phone: 336-716-3775
Responsible Party: Wake Forest University Health Sciences
ClinicalTrials.gov Identifier: NCT03037541     History of Changes
Other Study ID Numbers: IRB00014209
First Submitted: September 8, 2011
First Posted: January 31, 2017
Results First Submitted: January 31, 2017
Results First Posted: March 23, 2017
Last Update Posted: August 29, 2018