Study to Determine the Safety of PEP005 0.025% and 0.05% Topical Gel in Patients With Actinic Ker… (NCT00375739) | Clinical Trial Compass
CompletedPhase 2
Study to Determine the Safety of PEP005 0.025% and 0.05% Topical Gel in Patients With Actinic Keratoses
United States200 participantsStarted 2006-09
Plain-language summary
The purpose of this study is to determine whether topical application of PEP005 is safe for the treatment of actinic keratoses.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Male patients at least 18 years of age.
. Post-menopausal female patients i.e., no menses for at least 12 consecutive months, or without a uterus.
. 4 to 8 clinically typical, visible and discrete AK lesions within a contiguous 25 cm2 treatment area on the arm, shoulder, chest, back or scalp.
. Screening laboratory values within the reference ranges as defined by the central laboratory or "out of range" test results that are clinically acceptable to the Investigator.
. Ability to follow study instructions and likely to complete all study requirements.
. Written informed consent has been obtained.
. Written Authorization for Use and Release of Health and Research Study Information has been obtained.
. Agreement from the patient to allow photographs of the selected AK treatment area to be taken and used as part of the study data package.
Exclusion criteria
. Females of child bearing potential (a female is considered of childbearing potential unless she is postmenopausal, i.e., no menses for at least 12 consecutive months, or is without a uterus).
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
. AK lesions that have atypical clinical appearance e.g. hypertrophic, hyperkeratotic, recalcitrant disease (had cryosurgery on 2 previous occasions), cutaneous horns within the selected AK treatment area.
. Presence of suspected basal cell carcinoma (BCC) or squamous cell carcinoma (SCC) within the selected AK treatment area or within 10 cm of the selected AK treatment area.