Ignite Creation Date:
2025-12-24 @ 9:33 PM
Ignite Modification Date:
2025-12-25 @ 7:17 PM
Study NCT ID:
NCT00953732
Status:
COMPLETED
Last Update Posted:
2015-03-26
First Post:
2009-08-04
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Long Term Follow up Study of Patients Who Have Completed the PEP005-016 or PEP005-025 Studies
Sponsor:
Peplin
Organization:
Study Overview
Official Title:
A 12 Month, Long-term Follow-up Study of Patients With Actinic Keratosis on the Head (Face or Scalp) Who Have Completed Day 57 in Studies PEP005-016 or PEP005-025 (REGION IIa and IIb)
Status:
COMPLETED
Status Verified Date:
2015-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study is designed to follow up patients who have achieved complete clearance of AK lesions at the Day 57 visit having completed the PEP005-016 or PEP005-025 studies over a 12 month period to assess both recurrence of Actinic Keratosis (AK) lesions and long term safety in the selected treatment area.
Detailed Description:
A 12 month long-term follow-up study of patients who have achieved complete clearance of AK lesions at the Day 57 in the Phase 3 studies PEP005-016 or PEP005-025.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: