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Follow-up Study to Evaluate Sustained Clearance Rates of Actinic Keratoses up to One Year

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00668733
First Posted: April 29, 2008
Last Update Posted: July 20, 2010
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.
Information provided by:
Graceway Pharmaceuticals, LLC
Results First Submitted: June 15, 2010  
Study Type: Observational
Study Design: Observational Model: Cohort;   Time Perspective: Prospective
Condition: Actinic Keratoses

  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
This was a Phase 3b longitudinal and observational study.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Subjects previously enrolled in studies GW01-0702, GW01-0703, GW01-0704, or GW01-0705 and were completely cleared of their actinic keratosis (AK) lesions in the selected treatment area at the 8-week post-treatment (end-of-study [EOS]) visit returned for follow-up visits at 6 and 12 months after the EOS visit or until a recurrence of AKs.

Reporting Groups
  Description
2-Week Treatment Group Subjects who previously enrolled in studies GW01-0702 and GW01-0704 and were completely cleared of their actinic keratosis (AK) lesions in the selected treatment area at the 8-week post-treatment (end-of-study [EOS]) visit returned for follow-up visits at 6 and 12 months after the EOS visit or until a recurrence of AKs.
3-Week Treatment Group Subjects who previously enrolled in studies GW01-0703 and GW01-0705 and were completely cleared of their actinic keratosis (AK) lesions in the selected treatment area at the 8-week post-treatment (end-of-study [EOS]) visit returned for follow-up visits at 6 and 12 months after the EOS visit or until a recurrence of AKs.

Participant Flow:   Overall Study
    2-Week Treatment Group   3-Week Treatment Group
STARTED   89   90 
COMPLETED   87   83 
NOT COMPLETED   2   7 
Lost to Follow-up                2                3 
Withdrawal by Subject                0                4 



  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
2-Week Treatment Group Subjects who previously enrolled in studies GW01-0702 and GW01-0704 and were completely cleared of their actinic keratosis (AK) lesions in the selected treatment area at the 8-week post-treatment (end-of-study [EOS]) visit returned for follow-up visits at 6 and 12 months after the EOS visit or until a recurrence of AKs.
3-Week Treatment Group Subjects who previously enrolled in studies GW01-0703 and GW01-0705 and were completely cleared of their actinic keratosis (AK) lesions in the selected treatment area at the 8-week post-treatment (end-of-study [EOS]) visit returned for follow-up visits at 6 and 12 months after the EOS visit or until a recurrence of AKs.
Total Total of all reporting groups

Baseline Measures
   2-Week Treatment Group   3-Week Treatment Group   Total 
Overall Participants Analyzed 
[Units: Participants]
 89   90   179 
Age 
[Units: Participants]
     
<=18 years   0   0   0 
Between 18 and 65 years   42   50   92 
>=65 years   47   40   87 
Age 
[Units: Years]
Mean (Standard Deviation)
 65.0  (10.9)   64.0  (10.2)   64.5  (10.5) 
Gender 
[Units: Participants]
     
Female   25   18   43 
Male   64   72   136 
Region of Enrollment 
[Units: Participants]
     
United States   89   90   179 


  Outcome Measures

1.  Primary:   Number of Participants With Recurrence of AK Lesions   [ Time Frame: Up to one year ]


  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
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  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: Sharon F. Levy, MD / Sr. VP, Clinical Product Development
Organization: Graceway Pharmaceuticals
phone: 267-948-0400
e-mail: sharon.levy@gracewaypharma.com


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Sharon Levy, MD / Vice President, Product Development, Graceway Pharmaceuticals, LLC
ClinicalTrials.gov Identifier: NCT00668733     History of Changes
Other Study ID Numbers: GW01-0803
First Submitted: April 24, 2008
First Posted: April 29, 2008
Results First Submitted: June 15, 2010
Results First Posted: July 13, 2010
Last Update Posted: July 20, 2010