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Safety and Effectiveness Study of Actinic Keratosis Treatment Following Cryosurgery

This study has been completed.
Information provided by:
Graceway Pharmaceuticals, LLC Identifier:
First received: May 5, 2009
Last updated: August 23, 2010
Last verified: August 2010
Results First Received: July 28, 2010  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Actinic Keratosis
Interventions: Drug: imiquimod cream
Drug: placebo 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
Subjects were screened in 20 sites—16 in the United States of America (U.S.A.) and 4 in Canada. Screening began on 01 Jun 2009 and the last subject was enrolled on 03 Aug 2009.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Subjects had to have ≥10 AK lesions in an area the face to participate in the study. At screening, at least 5 visible lesions were not treated with cryosurgery, and 5 to 14 visible lesions were treated with cryosurgery. Subjects needed at least 5 AK lesions after the skin healed sufficiently from the cryosurgery to be eligible for randomization.

Reporting Groups
Placebo Cream placebo cream in 250 mg/packet, up to 2 packets applied daily
Imiquimod Cream Imiquimod 3.75% cream, 250 mg single-use packets, up to 2 packets applied daily

Participant Flow:   Overall Study
    Placebo Cream     Imiquimod Cream  
STARTED     121     126  
COMPLETED     111     112  
NOT COMPLETED     10     14  
Adverse Event                 5                 4  
Withdrawal by Subject                 4                 4  
Lost to Follow-up                 0                 2  
Non-compliance with study procedures                 0                 2  
Other, not due to AE                 1                 2  

  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
Placebo Cream placebo cream in 250 mg/packet, up to 2 packets applied daily
Imiquimod Cream Imiquimod 3.75% cream, 250 mg single-use packets, up to 2 packets applied daily
Total Total of all reporting groups

Baseline Measures
    Placebo Cream     Imiquimod Cream     Total  
Number of Participants  
[units: participants]
  121     126     247  
[units: participants]
<=18 years     0     0     0  
Between 18 and 65 years     48     63     111  
>=65 years     73     63     136  
[units: years]
Mean ± Standard Deviation
  67.3  ± 10.05     66.0  ± 9.49     66.7  ± 9.77  
[units: participants]
Female     15     18     33  
Male     106     108     214  
Region of Enrollment  
[units: participants]
United States     90     91     181  
Canada     31     35     66  

  Outcome Measures
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1.  Primary:   Change From Baseline in Percentage of Lesion Count   [ Time Frame: Week 26 ]

2.  Secondary:   Percent of Subjects With Complete Clearance   [ Time Frame: Week 26 ]

3.  Secondary:   Number of Participants With Any Post-baseline Local Skin Reactions (LSRs)   [ Time Frame: Weeks 2, 4, 6, 10, 14, 20, and 26 ]

  Serious Adverse Events

  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
A treatment-emergent AE (TEAE) was an AE that began or worsened in severity after the first application of study drug. TEAEs were summarized for each treatment group by overall incidence, descending order, relationship to study drug, and severity.

  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.

Results Point of Contact:  
Name/Title: Vice President Medical Affairs
Organization: Graceway Pharmaceuticals
phone: 267-948-0400

No publications provided

Responsible Party: Sharon Levy, MD, Graceway Pharmaceuticals, LLC Identifier: NCT00894647     History of Changes
Other Study ID Numbers: GW01-0901
Study First Received: May 5, 2009
Results First Received: July 28, 2010
Last Updated: August 23, 2010
Health Authority: United States: Food and Drug Administration
Canada: Health Canada