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

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.
ClinicalTrials.gov Identifier: NCT00668733
Recruitment Status : Completed
First Posted : April 29, 2008
Results First Posted : July 13, 2010
Last Update Posted : July 20, 2010
Sponsor:
Information provided by:

Study Description
Brief Summary:
The objective of this study was to obtain long-term sustained clearance rates for subjects previously treated with imiquimod creams in studies GW01-0702, GW01-0703, GW01-0704 and GW01-0705.

Condition or disease
Actinic Keratoses

Detailed Description:

This is a Phase 3 longitudinal and observational study. Subjects who previously enrolled in studies GW01-0702, GW01-0703, GW01-0704, and GW01-0705 and were completely cleared of their AK lesions in the selected treatment area at the end-of-study visit will return for follow-up visits at 6 and 12 months after the EOS visit or until a recurrence of AKs.

The NCT numbers for the above mentioned studies are:

NCT00603798 - for Studies GW01-0703 and GW01-0705

NCT00605176 for Studies GW01-0702 and GW01-0704


Study Design

Study Type : Observational
Actual Enrollment : 179 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Follow-up Study to Evaluate Sustained Clearance Rates of Actinic Keratoses up to One Year After Completion of Studies GW01-0702, GW01-0703, GW01-0704, and GW01-0705
Study Start Date : April 2008
Primary Completion Date : July 2009
Study Completion Date : July 2009

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts


Outcome Measures

Primary Outcome Measures :
  1. Number of Participants With Recurrence of AK Lesions [ Time Frame: Up to one year ]
    The primary efficacy variable in this study was the absence of AK lesions(sustained clearance rate) in the previously treated area.


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
The study population consisted of subjects who have been treated with imiquimod or with placebo in one of the aformentioned studies and who demonstrated complete clearance of all clinically visible or palpable AK lesions in the selected treatment area at the end-of-study visit.
Criteria

Inclusion Criteria:

  • Are willing and able to give informed consent;
  • Have successfully completed one of the following studies: GW01-0702, GW01- 0703, GW01-0704, or GW01-0705 and have been determined to be completely clear of AK lesions at the EOS visit in the designated treatment area from the previous study
  • Are willing to participate in the study as an outpatient, make visits to the study center for follow-up evaluation, and agree to comply with all study requirements.

Exclusion Criteria:

  • None. All subjects who meet the inclusion criteria above may participate.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00668733


Sponsors and Collaborators
Graceway Pharmaceuticals, LLC
Investigators
Study Director: Sharon Levy, MD Graceway Pharmaceuticals, LLC
More Information

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 Posted: April 29, 2008    Key Record Dates
Results First Posted: July 13, 2010
Last Update Posted: July 20, 2010
Last Verified: July 2010

Keywords provided by Graceway Pharmaceuticals, LLC:
Actinic keratoses
Dermatologic disease

Additional relevant MeSH terms:
Keratosis
Keratosis, Actinic
Skin Diseases
Precancerous Conditions
Neoplasms