Clinical trial NCT00953732: A Long Term Follow up Study of Patients Who Have Completed the PEP005-016 or PEP005-025 Studies
Official title: 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)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Actinic Keratosis
Keywords: Peplin
Actinic keratosis
PEP005
Lead sponsor: Peplin
Sponsor class: INDUSTRY
Collaborators: name: TKL Research, Inc.
First posted: 2009-08-06
Enrollment: 117
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients must have achieved complete clearance of AK lesions at Day 57 visit in either study PEP005-016 or PEP005-025 will be offered participation in this study.

Brief 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.

Eligibility criteria: Inclusion Criteria:

* Patient must have achieved complete clearance of AK lesions (lesion count = 0) at Day 57 in one of the following Peplin AK clinical studies: PEP005-016 or PEP005-025
* Patient has provided informed consent documented by signing the Informed Consent Form (ICF) prior to any study-related procedures

Exclusion Criteria:

* 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 PEP005-016 or PEP005-025

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 AEs in the treatment area)
timeFrame: 12 months
Other outcomes:
Locations:
city: Hot Springs
country: United States
facility: Burke Pharmaceutical Research
state: Arizona
city: Fremont
country: United States
facility: Center for Dermatology
state: California
city: Los Angeles
country: United States
facility: Dermatology Research Associates
state: California
city: Oceanside
country: United States
facility: Dermatology Specialists Inc
state: California
city: San Diego
country: United States
facility: Skin Surgery Medical Group Inc.
state: California
city: San Francisco
country: United States
facility: Conant Medical Group
state: California
city: Jacksonville
country: United States
facility: North Florida Dermatology Associates, PA
state: Florida
city: Miami
country: United States
facility: University of Miami, Skin Research Camp
state: Florida
city: Alpharetta
country: United States
facility: Atlanta Dermatology, Vein & Research Center, LLC
state: Georgia
city: Newnan
country: United States
facility: Medaphase Inc
state: Georgia
city: Arlington Heights
country: United States
facility: Altman Dermatology Associates
state: Illinois
city: Buffalo Grove
country: United States
facility: Glazer Dermatology
state: Illinois
city: Carmel
country: United States
facility: Laser Skin Surgery Center of Indiana
state: Indiana
city: Evansville
country: United States
facility: Deaconess Clinic, Inc
state: Indiana
city: Indianapolis
country: United States
facility: Dawes Fretein Clinical Research Group, LLC
state: Indiana
city: Plainfield
country: United States
facility: The Indiana Clinical Trials Center, PC
state: Indiana
city: Owensboro
country: United States
facility: Pedia Research LLC
state: Kentucky
city: Fort Gratiot
country: United States
facility: Hamzavi Dermatology
state: Michigan
city: Fridley
country: United States
facility: Minnesota Clinical Study Center
state: Minnesota
city: Omaha
country: United States
facility: Skin Specialists, PC
state: Nebraska
city: Henderson
country: United States
facility: Karl G. Heine Dermatology
state: Nevada
city: Albuquerque
country: United States
facility: Academic Dermatology Associates
state: New Mexico
city: New York
country: United States
facility: Mount Sinai School of Medicine
state: New York
city: Rochester
country: United States
facility: Dermatology Associates of Rochester, PC
state: New York
city: Charlotte
country: United States
facility: Dermatology, Laser Vein Specialists of the Carolinas
state: North Carolina
city: Raleigh
country: United States
facility: Wake Research Associates
state: North Carolina
city: Portland
country: United States
facility: Oregon Medical Research
state: Oregon
city: Nashville
country: United States
facility: Dermatology Research Associates
state: Tennessee
city: Austin
country: United States
facility: DermResearch, Inc.
state: Texas
city: College Station
country: United States
facility: J & S Studies, Inc.
state: Texas
city: Houston
country: United States
facility: Suzanne Bruce and Associates, The Center for Skin Research
state: Texas
city: San Antonio
country: United States
facility: Progressive Clinical Research
state: Texas
city: Tyler
country: United States
facility: Dermatology Associates of Tyler
state: Texas
city: Webster
country: United States
facility: Center for Clinical Studies
state: Texas
city: Salt Lake City
country: United States
facility: Dermatology Research Center, Inc.
state: Utah
city: Lynchburg
country: United States
facility: The Education and Research Foundation
state: Virginia
city: Norfolk
country: United States
facility: Virginia Clinical Research, Inc
state: Virginia
city: Spokane
country: United States
facility: Premier Clinical Research
state: Washington
city: Kogarah
country: Australia
facility: Southderm Pty Ltd
state: New South Wales
city: Kogarah
country: Australia
facility: St George Dematology and Skin Cancer Centre
state: New South Wales
city: Benowa
country: Australia
facility: The Skin Centre
state: Queensland
city: Carina Heights
country: Australia
facility: South East Dermatology, Belmont Specialist Centre
state: Queensland
Study officials:
affiliation: Chief Medical Officer
name: Eugene Bauer, MD
role: STUDY_DIRECTOR
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.