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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00668733
Other study ID # GW01-0803
Secondary ID
Status Completed
Phase N/A
First received April 24, 2008
Last updated July 13, 2010
Start date April 2008
Est. completion date July 2009

Study information

Verified date July 2010
Source Graceway Pharmaceuticals, LLC
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Observational

Clinical Trial 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.


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


Recruitment information / eligibility

Status Completed
Enrollment 179
Est. completion date July 2009
Est. primary completion date July 2009
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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.

Study Design

Observational Model: Cohort, Time Perspective: Prospective


Related Conditions & MeSH terms


Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Graceway Pharmaceuticals, LLC

Outcome

Type Measure Description Time frame Safety issue
Primary Number of Participants With Recurrence of AK Lesions The primary efficacy variable in this study was the absence of AK lesions(sustained clearance rate) in the previously treated area. Up to one year No
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