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NCT00114023 Clinical Trial

1-Year Follow up to the 1473-IMIQ Study

Keratosis Clinical Trial

Official title:
A Follow-up Study to Evaluate Actinic Keratosis Recurrence Rates One Year After Completion of the 1473-IMIQ Study

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00114023
Other study ID # 1518-IMIQ
Secondary ID
Status Completed
Phase Phase 3
First received June 13, 2005
Last updated February 16, 2007
Start date January 2005

Study information
Verified date October 2006
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

This is a 1-year follow-up study to evaluate the long-term effects in subjects who completely cleared their actinic keratosis (AK) lesions in the 1473-IMIQ study. The 1473-IMIQ study evaluated the safety and effectiveness of imiquimod 5% cream compared to a placebo cream for the treatment of AK.

Recruitment information / eligibility
Status Completed
Enrollment 84
Est. completion date
Est. primary completion date
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Subject had to participate in the 1473-IMIQ Study AND have had 100% clearance of AK lesions

Exclusion Criteria:

- Did not use any topical preparations in the previous treatment area within 24-hours of the scheduled visit.

Study Design

Observational Model: Defined Population, Time Perspective: Longitudinal

Related Conditions & MeSH terms

Intervention

Drug:
• Imiquimod 5% cream

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Graceway Pharmaceuticals, LLC

Country where clinical trial is conducted

United States, 

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