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

April 24, 2008
July 13, 2010
April 2008
July 2009   (final data collection date for primary outcome measure)
Number of Participants With Recurrence of AK Lesions [ Time Frame: Up to one year ] [ Designated as safety issue: No ]
The primary efficacy variable in this study was the absence of AK lesions(sustained clearance rate) in the previously treated area.
Recurrence of AK lesions [ Time Frame: Up to one year ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00668733 on ClinicalTrials.gov Archive Site
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Follow-up Study to Evaluate Sustained Clearance Rates of Actinic Keratoses up to One Year
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

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.

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

Observational
Observational Model: Cohort
Time Perspective: Prospective
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Non-Probability Sample

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.

Actinic Keratoses
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Hanke CW, Swanson N, Bruce S, Berman B, Kulp J, Levy S. Complete clearance is sustained for at least 12 months after treatment of actinic keratoses of the face or balding scalp via daily dosing with imiquimod 3.75% or 2.5% cream. J Drugs Dermatol. 2011 Feb;10(2):165-70.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
179
July 2009
July 2009   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
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NCT00668733
GW01-0803
No
Sharon Levy, MD / Vice President, Product Development, Graceway Pharmaceuticals, LLC
Graceway Pharmaceuticals, LLC
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Study Director: Sharon Levy, MD Graceway Pharmaceuticals, LLC
Graceway Pharmaceuticals, LLC
July 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP