Duration of Ameluz Application in Acral Actinic Keratoses Response (NCT03963102) | Clinical Trial Compass
TerminatedPhase 4
Duration of Ameluz Application in Acral Actinic Keratoses Response
Stopped: Lack of appropriate personnel. Dr Xie abroad on other research, current PI Dr John Frewen not at main centre, no other available PI identified. Study suspended.
United Kingdom28 participantsStarted 2019-10-30
Plain-language summary
A phase IV study of a single topical application of ALA for 3 hours or 4 hours to AK on acral sites (hands, feet, arms and legs), and subsequent measurement of clinical efficacy with corresponding PpIX fluorescence imaging.
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
. Patient has given written informed consent.
. Males and females \> 18 years.
. AK lesions on arms, hands, legs or feet that are practical to treat with PDT.
Exclusion criteria
. Lesions with a clinical diagnosis of Bowen's disease, superficial, morphoeic or nodular basal cell carcinoma, squamous cell carcinoma, or melanoma as they are not the types of lesions required for investigation.
. Any disease which is caused or exacerbated by light, including systemic lupus erythematosus, porphyria, actinic reticuloid or xeroderma pigmentosum. Part of the clinical study will be the use of light-imaging system so any condition, which is sensitive to such instruments, will be excluded.
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.
What they're measuring
1
The odds of full clearance of individual lesions in the intervention and control groups will be compared (reported as an odds ratio with 95%CLs).
. Males or females of childbearing potential, who are not practicing adequate contraceptive precaution. Female patients should practice strict birth control (oestrogen-containing oral contraceptives or an IUD) throughout the trial. Only post-menopausal women (12 months or more with no menses) and women who have had a hysterectomy are exempt from the requirements to use birth control. Male patients should also use adequate contraception for the duration of the trial.
. Pregnant or lactating females
. Treatment in the previous 45 days with any cryotherapy, topical treatments for AK, experimental compound, an iron chelating agent, radiotherapy, chemotherapy or with any light activated therapy or any other medication, which may render the patient light sensitive (e.g. PUVA).
. Photodynamic therapy treatment in the previous 90 days.
. Co-existing ophthalmic disease likely to require slit lamp examination within 30 days of PDT treatment.
. Known allergies to porphyrins, peanut, soya or excipients.