Open-Label Safety Study to Evaluate Imiquimod Cream, 5% for Large Areas of Actinic Keratosis

This study has been completed.
Sponsor:
Information provided by:
Graceway Pharmaceuticals, LLC
ClinicalTrials.gov Identifier:
NCT00116649
First received: June 30, 2005
Last updated: July 14, 2010
Last verified: July 2010
Results First Received: October 21, 2008  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Keratosis
Intervention: Drug: imiquimod cream

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Study start - 14 July 2005 at 31 study centers 500 subjects were planned, with up to 15 subjects enrolled at each study center; however, some study centers were unable to enroll 15 subjects, so active centers were asked to enroll additional subjects.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Open-label study - subjects were required to be at least 18 years of age and to have greater than 25 centimeters squared total treatment area(s) containing at least 4 clinically typical, visible, discrete, nonhypertrophic Actinic Keratosis lesions without any dermatological disease and/or condition in the treatment or surrounding area.

Reporting Groups
  Description
Aldara (Imiquimod) Cream Aldara (imiquimod) Cream 5%

Participant Flow:   Overall Study
    Aldara (Imiquimod) Cream  
STARTED     551 [1]
COMPLETED     396  
NOT COMPLETED     155  
Adverse Event                 20  
Lack of Efficacy                 1  
Lost to Follow-up                 32  
Withdrawal by Subject                 68  
Local Skin Reaction                 9  
Various Reasons                 18  
Protocol Specified                 7  
[1] 586 screened (34 not eligible) 552 enrolled 551 study population (1 subject not treated)



  Baseline Characteristics
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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
Aldara (Imiquimod) Cream Aldara (imiquimod) Cream 5%

Baseline Measures
    Aldara (Imiquimod) Cream  
Number of Participants  
[units: participants]
  551  
Age  
[units: participants]
 
<=18 years     0  
Between 18 and 65 years     207  
>=65 years     344  
Age  
[units: years]
Mean ± Standard Deviation
  67.5  ± 10.71  
Gender  
[units: participants]
 
Female     114  
Male     437  
Ethnicity (NIH/OMB)  
[units: participants]
 
Hispanic or Latino     22  
Not Hispanic or Latino     529  
Unknown or Not Reported     0  
Race (NIH/OMB)  
[units: participants]
 
American Indian or Alaska Native     0  
Asian     0  
Native Hawaiian or Other Pacific Islander     0  
Black or African American     0  
White     551  
More than one race     0  
Unknown or Not Reported     0  
Region of Enrollment  
[units: participants]
 
United States     551  
Baseline actinic keratosis lesion count  
[units: actinic┬ákeratosis┬álesions]
Mean ± Standard Deviation
  45.5  ± 2.36  



  Outcome Measures
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1.  Primary:   Number of Participants Who Experienced an Adverse Event   [ Time Frame: from first dose up to 18 months ]

2.  Secondary:   Percent Reduction From Baseline to the Final Follow-up in Total Actinic Keratosis Lesion Count   [ Time Frame: At Month 18 ]


  Serious Adverse Events
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Time Frame Adverse events that occurred between the first day of exposure to the study cream up until study discharge were reported. Expsure could be up to three 16-week treatment cycles depending upon treatment success and AK lesion recurrence.
Additional Description Reporting of AEs by subjects was recorded. Local skin reactions (LSRs) in the treatment areas were also evaluated. These were erythema, edema, weeping/ exudate, vesicles, erosion/ulceration, flaking/scaling/dryness, and scabbing/crusting. Other skin-related reactions not listed, such as burning, itching, bleeding, etc., were documented as AEs.

Reporting Groups
  Description
Aldara (Imiquimod) Cream Aldara (imiquimod) Cream 5%

Serious Adverse Events
    Aldara (Imiquimod) Cream  
Total, serious adverse events    
# participants affected / at risk     39/551 (7.08%)  
Cardiac disorders    
Bradycardia † 1  
# participants affected / at risk     1/551 (0.18%)  
# events     1  
Myocardial infarction † 1  
# participants affected / at risk     4/551 (0.73%)  
# events     4  
Acute Myocardial Infarction † 1  
# participants affected / at risk     1/551 (0.18%)  
# events     1  
Coronary artery disease † 1  
# participants affected / at risk     4/551 (0.73%)  
# events     4  
Cardiac disorder † 1  
# participants affected / at risk     1/551 (0.18%)  
# events     1  
Ventricular tachycardia † 1  
# participants affected / at risk     1/551 (0.18%)  
# events     1  
Mitral valve incompetence † 1  
# participants affected / at risk     1/551 (0.18%)  
# events     1  
Angina unstable † 1  
# participants affected / at risk     2/551 (0.36%)  
# events     2  
General disorders    
Chest pain † 1  
# participants affected / at risk     2/551 (0.36%)  
# events     2  
Hepatobiliary disorders    
Hepatic cirrhosis † 1  
# participants affected / at risk     1/551 (0.18%)  
# events     1  
Cholelithiasis † 1  
# participants affected / at risk     2/551 (0.36%)  
# events     2  
Gallbladder disorder † 1  
# participants affected / at risk     1/551 (0.18%)  
# events     1  
Infections and infestations    
Bacteraemia † 1  
# participants affected / at risk     1/551 (0.18%)  
# events     3  
Urinary tract infection † 1  
# participants affected / at risk     1/551 (0.18%)  
# events     1  
Lobar pneumonia † 1  
# participants affected / at risk     1/551 (0.18%)  
# events     1  
Pneumonia † 1  
# participants affected / at risk     2/551 (0.36%)  
# events     2  
Cellulitis † 1  
# participants affected / at risk     1/551 (0.18%)  
# events     1  
Upper respiratory tract infection † 1  
# participants affected / at risk     1/551 (0.18%)  
# events     1  
Injury, poisoning and procedural complications    
Device failure † 1  
# participants affected / at risk     1/551 (0.18%)  
# events     1  
Concussion † 1  
# participants affected / at risk     1/551 (0.18%)  
# events     1  
Metabolism and nutrition disorders    
Dehydration † 1  
# participants affected / at risk     2/551 (0.36%)  
# events     2  
Musculoskeletal and connective tissue disorders    
Intrervertebral disc protrusion † 1  
# participants affected / at risk     1/551 (0.18%)  
# events     1  
Spondyloarthropathy † 1  
# participants affected / at risk     1/551 (0.18%)  
# events     1  
Intervertebral disk protrusion † 1  
# participants affected / at risk     1/551 (0.18%)  
# events     1  
Neoplasms benign, malignant and unspecified (incl cysts and polyps)    
Gastric cancer † 1  
# participants affected / at risk     1/551 (0.18%)  
# events     1  
Lung neoplasm malignant † 1  
# participants affected / at risk     1/551 (0.18%)  
# events     1  
Thyroid neoplasm † 1  
# participants affected / at risk     1/551 (0.18%)  
# events     1  
Renal cancer † 1  
# participants affected / at risk     1/551 (0.18%)  
# events     1  
Colon cancer † 1  
# participants affected / at risk     1/551 (0.18%)  
# events     1  
Prostate cancer † 1  
# participants affected / at risk     2/551 (0.36%)  
# events     2  
Nervous system disorders    
Cerebrovascular accident † 1  
# participants affected / at risk     2/551 (0.36%)  
# events     2  
Syncope † 1  
# participants affected / at risk     1/551 (0.18%)  
# events     1  
Haemorrhagic stroke † 1  
# participants affected / at risk     1/551 (0.18%)  
# events     1  
Carotid artery occlusion † 1  
# participants affected / at risk     1/551 (0.18%)  
# events     1  
Respiratory, thoracic and mediastinal disorders    
Pulmonary embolism † 1  
# participants affected / at risk     1/551 (0.18%)  
# events     1  
Vascular disorders    
Arteriosclerosis † 1  
# participants affected / at risk     2/551 (0.36%)  
# events     3  
Hypertension † 1  
# participants affected / at risk     1/551 (0.18%)  
# events     1  
Events were collected by systematic assessment
1 Term from vocabulary, MedDRA (9.0)




  Other Adverse Events


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


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.  


Results Point of Contact:  
Name/Title: Sharon Levy, MD VP Product Development
Organization: Graceway Pharmaceuticals LLC
phone: 267-948-0500
e-mail: sharon.levy@gracewaypharma.com


Publications of Results:
Del Rosso JQ, Sofen H, Leshin B, Meng TC, Kulp J, Levy S. Safety and Efficacy of Multiple 16-week Courses of Topical Imiquimod for the Treatment of Large Areas of Skin Involved with Actinic Keratoses. Clin Aesthetic Dermatol. 2009;2(4):20-28.


Responsible Party: Sharon Levy, MD VP Product Development, Graceway Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00116649     History of Changes
Other Study ID Numbers: 1520-IMIQ
Study First Received: June 30, 2005
Results First Received: October 21, 2008
Last Updated: July 14, 2010
Health Authority: United States: Food and Drug Administration