Study to Determine the Safety of Two Applications of PEP005 Topical Gel to Cutaneous Squamous Cel… (NCT00329121) | Clinical Trial Compass
CompletedPhase 2
Study to Determine the Safety of Two Applications of PEP005 Topical Gel to Cutaneous Squamous Cell Carcinoma In Situ
Australia24 participantsStarted 2006-05
Plain-language summary
The purpose of this study is to determine whether the topical application of PEP005 is safe and effective for the treatment of cutaneous squamous cell carcinoma in situ (SCCIS, Bowen's disease).
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, at least 18 years of age, i.e. no menses for at least 12 consecutive months, or without a uterus.
. A primary, clinically diagnosed and histologically confirmed SCCIS lesion with the histological diagnosis being made within 90 days of the screening visit.
. Longest diameter of the SCCIS lesion between 5 mm and 20 mm.
. Ability to follow study instructions and likely to complete all study requirements.
. Written informed consent has been obtained.
. Written consent for tissue from the biopsy of the histologically confirmed SCCIS lesion to be examined and stored by the central dermatopathologist has been obtained.
. Agreement from the patient to allow photographs of the selected SCCIS treatment area (including the face) to be used as part of the study data package.
Exclusion criteria
. Females of childbearing potential (a female is considered of childbearing potential unless she is post-menopausal, 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.
. on the scalp, digits, lips, hands, feet, or ano-genital region
. SCCIS lesions that have atypical clinical appearance, e.g. hypertrophic or hyperkeratotic or pigmented or ulcerated.
. Histological evidence of nodular basal cell carcinoma (nBCC), superficial basal cell carcinoma (sBCC) or invasive squamous cell carcinoma (SCC) of the SCCIS in the biopsy sample.