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 range18 Years
SexALL
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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.
✕. 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.
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).