A Study to Follow up Recurrence Rates of Actinic Keratoses One Year After Completion of Study 1487-IMIQ
Sponsor
MEDA Pharma GmbH & Co. KG (Industry)
Overall Status
Completed
CT.gov ID
NCT00189254
Collaborator
(none)
72
7
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
Study Design
Study Type:
Observational
Time Perspective:
Prospective
Official Title:
A Follow-up Study to Evaluate Actinic Keratosis Recurrence Rates One Year After Completion of the 1487-IMIQ Study
Study Start Date
:
Apr 1, 2005
Actual Primary Completion Date
:
Nov 1, 2005
Actual Study Completion Date
:
Nov 1, 2005
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Imiquimod 5% cream No investigational treatments were given during this study. |
Drug: Imiquimod
No defined treatments were given during this study.
|
Outcome Measures
Primary Outcome Measures
- Efficacy [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).
- Safety [one year after completion of study 1487-Imiq]
Safety was evaluated by assessing the area of previous treatment for LSRs and skin quality
- Adverse Events [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.
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- MEDA Pharma GmbH & Co. KG
Investigators
- Study Chair: Study Coordinator, Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
MEDA Pharma GmbH & Co. KG
ClinicalTrials.gov Identifier:
NCT00189254
Other Study ID Numbers:
- 1524-IMIQ
First Posted:
Sep 19, 2005
Last Update Posted:
Feb 7, 2022
Last Verified:
Apr 1, 2015
Keywords provided by MEDA Pharma GmbH & Co. KG
Additional relevant MeSH terms: