A Study to Follow up Recurrence Rates of Actinic Keratoses One Year After Completion of Study 1487-IMIQ
February 4, 2022 updated by: MEDA Pharma GmbH & Co. KG
A Follow-up Study to Evaluate Actinic Keratosis Recurrence Rates One Year After Completion of the 1487-IMIQ Study
The purpose of the study is to obtain recurrence rates and long-term safety data for patients who had been treating actinic keratoses on the face and scalp with 5 % Imiquimod Cream in a previous study.
Study Overview
Study Type
Observational
Enrollment
72
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
At least 18 years old.
Females of childbearing potential, with a negative urine pregnancy test, must have been willing to use a medically acceptable method of contraception during the treatment.
Description
Inclusion Criteria:
- 100% clearance of Actinic Keratosis (AK) lesions in the 1487 IMIQ study
Exclusion Criteria:
- used any treatments in the previous treatment area within 24 hours prior to the follow-up visit
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Imiquimod 5% cream
No investigational treatments were given during this study.
|
No defined treatments were given during this study.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Efficacy
Time Frame: one year after completion of study 1487-Imiq
|
Efficacy was evaluated by counting AK lesions in the previous treatment area.
Subjects at the 1-year follow-up visit with recurrence of lesion(s).
|
one year after completion of study 1487-Imiq
|
|
Safety
Time Frame: one year after completion of study 1487-Imiq
|
Safety was evaluated by assessing the area of previous treatment for LSRs and skin quality
|
one year after completion of study 1487-Imiq
|
|
Adverse Events
Time Frame: one year after completion of study 1487-Imiq
|
AEs considered by investigator to be possibly or probably related to the 1487-Imiq study medication were documented and recorded.
|
one year after completion of study 1487-Imiq
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Chair: Study Coordinator, Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2005
Primary Completion (ACTUAL)
November 1, 2005
Study Completion (ACTUAL)
November 1, 2005
Study Registration Dates
First Submitted
September 12, 2005
First Submitted That Met QC Criteria
September 12, 2005
First Posted (ESTIMATE)
September 19, 2005
Study Record Updates
Last Update Posted (ACTUAL)
February 7, 2022
Last Update Submitted That Met QC Criteria
February 4, 2022
Last Verified
April 1, 2015
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1524-IMIQ
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.