Safety and Effectiveness Study of Actinic Keratosis Treatment Following Cryosurgery

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00894647
Recruitment Status : Completed
First Posted : May 7, 2009
Results First Posted : August 23, 2010
Last Update Posted : August 31, 2010
Information provided by:
Graceway Pharmaceuticals, LLC

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Actinic Keratosis
Interventions: Drug: imiquimod cream
Drug: placebo 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
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

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 
Overall Participants Analyzed 
[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

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

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

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

Responsible Party: Sharon Levy, MD, Graceway Pharmaceuticals, LLC Identifier: NCT00894647     History of Changes
Other Study ID Numbers: GW01-0901
First Submitted: May 5, 2009
First Posted: May 7, 2009
Results First Submitted: July 28, 2010
Results First Posted: August 23, 2010
Last Update Posted: August 31, 2010