NCT00953732

A Long Term Follow up Study of Patients Who Have Completed the PEP005-016 or PEP005-025 Studies

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
• Phase: —
• Study type: Observational
• Enrollment: 117 (actual)
• Sponsor: Peplin · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Actinic Keratosis

Interventions

Type	Name	Description
DRUG	Lesion count	Lesion count in area treated by study drug in a prior study. No drug will be applied during this long-term follow up study. Drug was applied during the primary study.

Timeline

• Start date: 2009-08-01
• Primary completion: 2010-10-01
• Completion: 2010-10-01
• First posted: 2009-08-06
• Last updated: 2015-03-26

Locations

42 sites across 2 countries: United States, Australia