Clinical trial NCT00952783: A Long Term Follow up Study of Patients Who Have Completed the PEP005-020 Study
Official title: A 12 Month, Long-term Follow-up Study of Patients With Actinic Keratosis on Non-head Areas (Trunk and Extremities) Who Have Completed Day 57 in Study PEP005-020
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Actinic Keratosis
Keywords: Peplin
Actinic keratosis
PEP005
Lead sponsor: Peplin
Sponsor class: INDUSTRY
First posted: 2009-08-06
Enrollment: 98
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who have achieved complete clearance of AK lesions (lesion count of 0) at Day 57 in study PEP005-020

Brief summary: This study is designed to follow up patients, who have achieved complete clearance of AK lesions (lesion count of 0) at Day 57 in the PEP005-020 study, over a 12 month period to assess both recurrence of Actinic Keratosis (AK) lesions and long term safety in the selected treatment area.


Eligibility 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 study PEP005-020

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 PEP005-020

Primary outcomes:
measure: Summarize treatment area recurrence of AK lesions in the selected treatment area
timeFrame: 12 months
Secondary outcomes:
measure: Summarize long-term safety data (incidence of adverse events in the treatment area)
timeFrame: 12 months
Other outcomes:
Locations:
city: Orange Park
country: United States
facility: Park Avenue Dermatology
state: Florida
city: Newnan
country: United States
facility: Medaphase Inc
state: Georgia
city: Snellville
country: United States
facility: Gwinnett Clinical Research Centre
state: Georgia
city: Clinton Twp
country: United States
facility: Michigan Center for Research Corp
state: Michigan
city: Detroit
country: United States
facility: Henry Ford Health Systems
state: Michigan
city: Rochester
country: United States
facility: Dermatology Associates of Rochester
state: New York
city: Portland
country: United States
facility: Oregon Health and Science University
state: Oregon
city: Nashville
country: United States
facility: Dermatology Research Associates
state: Tennessee
city: Adelaide
country: Australia
facility: Dematology on Ward
state: South Australia
city: Melbourne
country: Australia
facility: Dermatology Institute of Victoria
state: Victoria
city: Subiaco
country: Australia
facility: St John of God Dermatology
state: Western Australia
Study officials:
References:
citation: Lebwohl M, Shumack S, Stein Gold L, Melgaard A, Larsson T, Tyring SK. Long-term follow-up study of ingenol mebutate gel for the treatment of actinic keratoses. JAMA Dermatol. 2013 Jun;149(6):666-70. doi: 10.1001/jamadermatol.2013.2766.