A Study to Follow up Recurrence Rates of Actinic Keratoses One Year After Completion of Study 1487-IMIQ

Completed

• Conditions: Actinic Keratoses
• Interventions: Drug: Imiquimod

• Registration Number: NCT00189254
• Lead Sponsor: MEDA Pharma GmbH & Co. KG

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2005-04
• Study First Submitted: 2005-09-12
• Study First Submitted QC: 2005-09-12
• Study First Posted: 2005-09-19
• Primary Completion: 2005-11
• Study Completion: 2005-11
• Status Verified: 2015-04
• Last Update Submitted: 2022-02-04
• Last Update Posted: 2022-02-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 72

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Imiquimod 5% cream	Imiquimod	No investigational treatments were given during this study.

Primary Outcome Measures

Name	Time	Method
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.