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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 : December 7, 2017
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

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
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


Participant Flow:   Overall Study
    Group 1 Carac (Fluorouracil) 0.5% Cream   Group 2 Placebo
STARTED   30   30 
COMPLETED   30   30 
NOT COMPLETED   0   0 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
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

Total Total of all reporting groups

Baseline Measures
   Group 1 Carac (Fluorouracil) 0.5% Cream   Group 2 Placebo   Total 
Overall Participants Analyzed 
[Units: Participants]
 30   30   60 
Age 
[Units: Participants]
Count of 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 
[Units: Participants]
Count of Participants
     
Female      3  10.0%      2   6.7%      5   8.3% 
Male      27  90.0%      28  93.3%      55  91.7% 
Ethnicity (NIH/OMB) 
[Units: Participants]
Count of 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) 
[Units: Participants]
Count of 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 
[Units: Participants]
     
United States   30   30   60 


  Outcome Measures

1.  Primary:   Number Participants With 100% Clearance   [ Time Frame: 24 weeks ]

2.  Secondary:   Number of Participants With 75% Clearance   [ Time Frame: 24 weeks ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information

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
e-mail: jjorizzo@wakehealth.edu



Responsible Party: Wake Forest University Health Sciences
ClinicalTrials.gov Identifier: NCT03037541     History of Changes
Other Study ID Numbers: Carac & Cryo
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: December 7, 2017