A Long Term Follow up Study of Patients Who Have Complete Clearance of Their Actinic Keratosis (AK) Lesions at the Day 57 Visit in the PEP005-028 Study

Completed

• Conditions: Actinic Keratosis
• Interventions: Drug: Lesion count

• Registration Number: NCT00989313
• Lead Sponsor: Peplin

Brief Summary

This study is designed to follow up patients, who have participated in the PEP005-028 study and observed complete clearance of their Actinic Keratosis (AK) lesions, over a 12 month period to assess both recurrence of AK lesions and long term safety in the selected treatment area.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-09
• Study First Submitted: 2009-10-01
• Study First Submitted QC: 2009-10-02
• Study First Posted: 2009-10-05
• Primary Completion: 2010-10
• Study Completion: 2010-10
• Status Verified: 2015-03
• Last Update Submitted: 2015-03-25
• Last Update Posted: 2015-03-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 43

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
1	Lesion count	-

Primary Outcome Measures

Name	Time	Method
Summarize treatment area recurrence of AK lesions, in the selected treatment area during a 12 month follow-up period for patients with complete clearance, who have completed Day 57 in Study PEP005-028.	12 months

Secondary Outcome Measures

Name	Time	Method
Summarize long-term safety data, in the selected treatment area over a 12 month follow-up period for patients with complete clearance, who have completed Day 57 in Study PEP005-028.	12 months

Trial Locations

Locations (17)

Burke Pharmaceutical Research; 🇺🇸 Hot Springs, Arizona, United States

Skin Surgery Medical Group Inc.; 🇺🇸 San Diego, California, United States

Atlanta Dermatology, Vein & Research Center, LLC; 🇺🇸 Alpharetta, Georgia, United States

Altman Dermatology Associates; 🇺🇸 Arlington Heights, Illinois, United States

Glazer Dermatology; 🇺🇸 Buffalo Grove, Illinois, United States

Deaconess Clinic Downtown; 🇺🇸 Evansville, Indiana, United States

Dawes Fretzin Clinical Research Group, LLC; 🇺🇸 Indianapolis, Indiana, United States

Skin Specialists, PC; 🇺🇸 Omaha, Nebraska, United States

Karl G. Heine Dermatology; 🇺🇸 Henderson, Nevada, United States

Group Health Associates; 🇺🇸 Cincinnati, Ohio, United States

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