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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;   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 
Overall Participants Analyzed 
[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 keratosis lesions]
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


  Limitations and Caveats
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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
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