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NCT00989313 Clinical Trial

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

Actinic Keratosis Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00989313
Other study ID # PEP005-032
Secondary ID
Status Completed
Phase Phase 3
First received October 1, 2009
Last updated March 25, 2015
Start date September 2009
Est. completion date October 2010

Study information
Verified date March 2015
Source Peplin
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug AdministrationAustralia: Department of Health and Ageing Therapeutic Goods Administration
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 43
Est. completion date October 2010
Est. primary completion date October 2010
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

Intervention

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.

Locations
Country Name City State
United States Atlanta Dermatology, Vein & Research Center, LLC Alpharetta Georgia
United States Altman Dermatology Associates Arlington Heights Illinois
United States DermResearch, Inc. Austin Texas
United States Glazer Dermatology Buffalo Grove Illinois
United States Group Health Associates Cincinnati Ohio
United States Deaconess Clinic Downtown Evansville Indiana
United States Karl G. Heine Dermatology Henderson Nevada
United States Burke Pharmaceutical Research Hot Springs Arizona
United States Suzanne Bruce and Associates, PA, The Center for Skin Research Houston Texas
United States Dawes Fretzin Clinical Research Group, LLC Indianapolis Indiana
United States The Education and Research Foundation Lynchburg Virginia
United States Virginia Clinical Research, Inc Norfolk Virginia
United States Skin Specialists, PC Omaha Nebraska
United States Dermatology Research Centre Salt Lake City Utah
United States Dermatology Clinical Research Center of San Antonio San Antonio Texas
United States Skin Surgery Medical Group Inc. San Diego California
United States Dermatology Associates of Tyler Tyler Texas

Sponsors (1)
Lead Sponsor Collaborator
Peplin

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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 Yes
Secondary 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 Yes
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Completed NCT02902822 - Tele-dermatology of Skin Cancer in a Cohort of Local Health Authority Employees in the Province of Bergamo N/A
Completed NCT02878382 - Potential Impact of Patient Vitamin D Status in AK Response to MAL-PDT N/A
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