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

This study has been completed.

First Received on October 1, 2009. Last Updated on October 19, 2010 History of Changes

Sponsor:	Peplin
Information provided by:	Peplin
ClinicalTrials.gov Identifier:	NCT00989313

Purpose

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.

Condition	Phase
Actinic Keratosis	Phase III

Study Type:	Observational
Study Design:	Observational Model: Case-Only Time Perspective: Prospective
Official Title:	A 12 Month, Long-term Follow-up Study of Patients With Actinic Keratosis on Non-head Locations (Trunk and Extremities) Who Have Completed Day 57 in Study PEP005-028 (REGION Ib)

Resource links provided by NLM:

Drug Information available for: 3-Ingenyl angelate

U.S. FDA Resources

Further study details as provided by Peplin:

Primary Outcome Measures:

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. [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

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. [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]

Enrollment:	43
Study Start Date:	September 2009
Study Completion Date:	October 2010
Primary Completion Date:	October 2010 (Final data collection date for primary outcome measure)

Groups/Cohorts
1

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

Patients who achieved complete clearance of AK lesions at the Day 57 visit in the PEP005-028 study

Criteria

Inclusion

Patient has provided informed consent documented by signing the Informed Consent Form (ICF) prior to any study-related procedures
Patient achieved complete clearance of AK lesions (lesion count of 0) in the selected treatment area at the Day 57 visit in the following Peplin AK clinical Study: PEP005-028

Exclusion

Concurrent participation in another research study which would involve the selected treatment area (except for any post-study follow-up visits for previous Peplin AK study)
Early termination from study PEP005-028

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00989313

Locations

United States, Arizona
Burke Pharmaceutical Research
Hot Springs, Arizona, United States, 71913
United States, California
Skin Surgery Medical Group Inc.
San Diego, California, United States, 92117
United States, Georgia
Atlanta Dermatology, Vein & Research Center, LLC
Alpharetta, Georgia, United States, 30022
United States, Illinois
Altman Dermatology Associates
Arlington Heights, Illinois, United States, 60005
Glazer Dermatology
Buffalo Grove, Illinois, United States, 60089
United States, Indiana
Deaconess Clinic Downtown
Evansville, Indiana, United States, 47713
Dawes Fretzin Clinical Research Group, LLC
Indianapolis, Indiana, United States, 46256
United States, Nebraska
Skin Specialists, PC
Omaha, Nebraska, United States, 68144
United States, Nevada
Karl G. Heine Dermatology
Henderson, Nevada, United States, 89002
United States, Ohio
Group Health Associates
Cincinnati, Ohio, United States, 45220
United States, Texas
DermResearch, Inc.
Austin, Texas, United States, 78759
Suzanne Bruce and Associates, PA, The Center for Skin Research
Houston, Texas, United States, 77056
Dermatology Clinical Research Center of San Antonio
San Antonio, Texas, United States, 78229
Dermatology Associates of Tyler
Tyler, Texas, United States, 75703
United States, Utah
Dermatology Research Centre
3920 South 1100 East Suite 210 & 310 Salt Lake City, Utah, United States, 84124
United States, Virginia
The Education and Research Foundation
Lynchburg, Virginia, United States, 24501
Virginia Clinical Research, Inc
Norfolk, Virginia, United States, 23507

Sponsors and Collaborators

Peplin

More Information

Additional Information:

Sponsor

Food and Drug Authority This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Janelle Katsamas, Peplin
ClinicalTrials.gov Identifier:	NCT00989313 History of Changes
Other Study ID Numbers:	PEP005-032
Study First Received:	October 1, 2009
Last Updated:	October 19, 2010
Health Authority:	United States: Food and Drug Administration; Australia: Department of Health and Ageing Therapeutic Goods Administration

Keywords provided by Peplin:

Peplin
Actinic keratosis
PEP005

Additional relevant MeSH terms:

Keratosis
Keratosis, Actinic
Skin Diseases
Precancerous Conditions
Neoplasms

ClinicalTrials.gov processed this record on February 09, 2012