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

This study has been completed.
Sponsor:
Information provided by:
Graceway Pharmaceuticals, LLC
ClinicalTrials.gov Identifier:
NCT00668733
First received: April 24, 2008
Last updated: July 13, 2010
Last verified: July 2010
Results First Received: 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  
Number of Participants  
[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


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


No publications provided by Graceway Pharmaceuticals, LLC

Publications automatically indexed to this study:

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
Study First Received: April 24, 2008
Results First Received: June 15, 2010
Last Updated: July 13, 2010
Health Authority: United States: Food and Drug Administration