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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

participants targeted

Target at P50-P75 for all trials

Timeline

Completed

Started Jul 2009

Geographic Reach

2 countries

11 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

1.3 years study duration

Study Start

First participant enrolled

July 1, 2009

Completed

1 month until next milestone

First Submitted

Initial submission to the registry

August 4, 2009

Completed

2 days until next milestone

First Posted

Study publicly available on registry

August 6, 2009

Completed

1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2010

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2010

Completed

Last Updated

March 26, 2015

Status Verified

March 1, 2015

Enrollment Period

1.3 years

First QC Date

August 4, 2009

Last Update Submit

March 25, 2015

Conditions

Actinic Keratosis

Keywords

PeplinActinic keratosisPEP005

Outcome Measures

Primary Outcomes (1)

Summarize treatment area recurrence of AK lesions in the selected treatment area
12 months

Secondary Outcomes (1)

Summarize long-term safety data (incidence of adverse events in the treatment area)
12 months

Study Arms (1)

1

Drug: Lesion count

Interventions

Lesion countDRUG

Lesion count in area treated by study drug in a prior study over a 12 month period No drug will be applied during this long-term follow up study. Drug was applied during the primary study.

Also known as: AK lesion recurrence

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

Sampling MethodNon-Probability Sample

Study Population

Patients who have achieved complete clearance of AK lesions (lesion count of 0) at Day 57 in study PEP005-020

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Peplinlead

Study Sites (11)

Park Avenue Dermatology

Orange Park, Florida, 32073, United States

Location

Medaphase Inc

Newnan, Georgia, 30263, United States

Location

Gwinnett Clinical Research Centre

Snellville, Georgia, 30078-3250, United States

Location

Michigan Center for Research Corp

Clinton Twp, Michigan, 48038, United States

Location

Henry Ford Health Systems

Detroit, Michigan, 48202, United States

Location

Dermatology Associates of Rochester

Rochester, New York, 14623, United States

Location

Oregon Health and Science University

Portland, Oregon, 97239-4501, United States

Location

Dermatology Research Associates

Nashville, Tennessee, 37203, United States

Location

Dematology on Ward

Adelaide, South Australia, 5006, Australia

Location

Dermatology Institute of Victoria

Melbourne, Victoria, 3141, Australia

Location

St John of God Dermatology

Subiaco, Western Australia, 6008, Australia

Location

Related Publications (1)

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.
PMID: 23553119DERIVED

MeSH Terms

Conditions

Keratosis, Actinic

Condition Hierarchy (Ancestors)

Precancerous ConditionsNeoplasmsKeratosisSkin DiseasesSkin and Connective Tissue Diseases

Study Design

Study Type: observational
Observational Model: CASE ONLY
Time Perspective: PROSPECTIVE
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

August 4, 2009

First Posted

August 6, 2009

Study Start

July 1, 2009

Primary Completion

October 1, 2010

Study Completion

October 1, 2010

Last Updated

March 26, 2015

Record last verified: 2015-03

Locations

US(8)AU(3)

A Long Term Follow up Study of Patients Who Have Completed the PEP005-020 Study

Brief Summary

Trial Health

Trial Health Score

Trial Relationships

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (1)

Study Arms (1)

1

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (11)

Related Publications (1)

Related Links

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Design

Study Record Dates

Locations

Brief Summary

Trial Health

Trial Health Score

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (1)

Study Arms (1)

1

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (11)

Related Publications (1)

Related Links

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Design

Study Record Dates

Locations