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
  Purpose

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
Actinic Keratoses

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Graceway Pharmaceuticals, LLC:

Primary Outcome Measures:
  • 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.


Enrollment: 179
Study Start Date: April 2008
Study Completion Date: July 2009
Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00668733

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

No publications provided by Graceway Pharmaceuticals, LLC

Additional 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
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

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

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

ClinicalTrials.gov processed this record on September 14, 2014