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Completed

NCT Number: NCT00668733

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  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.

Sponsors and collaborators

Lead sponsor

Graceway Pharmaceuticals, LLC

Industry

Registry information

Official study 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

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Apr 29, 2008
Registry last updated
Jul 20, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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