Actinic Keratoses Clinical Trial
Official title:
A Study to Investigate the Effect of Different Durations of Ameluz Application on Response to Treatment of Acral Actinic Keratoses
Verified date | July 2022 |
Source | Royal Cornwall Hospitals Trust |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Suspended |
Enrollment | 74 |
Est. completion date | October 1, 2024 |
Est. primary completion date | October 1, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: 1. Patient has given written informed consent. 2. Males and females > 18 years. 3. AK lesions on arms, hands, legs or feet that are practical to treat with PDT. Exclusion Criteria: 1. 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. 2. 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. 3. 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. 4. Pregnant or lactating females 5. 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). 6. Photodynamic therapy treatment in the previous 90 days. 7. Co-existing ophthalmic disease likely to require slit lamp examination within 30 days of PDT treatment. 8. Known allergies to porphyrins, peanut, soya or excipients. 9. Patients not able to comply with study requirements. 10. Patients on immunosuppression medication. |
Country | Name | City | State |
---|---|---|---|
United Kingdom | Royal Cornwall Hospital | Truro | Cornwall |
Lead Sponsor | Collaborator |
---|---|
Royal Cornwall Hospitals Trust |
United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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). | Clinical outcome at 3 months of the treated AK lesions on acral sites | 3 months | |
Secondary | Clearance of lesions on other body sites | The odds of full clearance of any non-acral individual lesions in the intervention and control groups will be compared (reported as an odds ratio with 95%CLs). Lesions will be either cleared or not cleared. | 3 months | |
Secondary | Pain Score | The mean of pain levels as measure by the Visual Analogue Scale with standard deviation will be provided between treatment arms. | 1 week | |
Secondary | Photobleaching | Photobleaching will be calculated as the difference in fluorescence score before and after light treatment (change score). This is measured using the Dyaderm Fluroscence imaging system. | After data collection is completed, during analysis phase, expected at 12 months. | |
Secondary | PpIX accumulation fluorescence | PpIX accumulation over time (3 measurements for each lesion) will be presented graphically, grouped by participant and lesion type (acral and non-acral). The accumulation score is the PpIX fluroscence measured before light treatment.
The fluorescence before light treatment will be compared between intervention and control groups with a random effects model. The analysis will be adjusted for baseline fluorescence, grade of lesion, and location of lesion. A change score analysis will be carried out for comparison. |
After data collection is completed, during analysis phase, expected at 12 months. | |
Secondary | PpIX dissipation fluorescence | PpIX dissipation over time (3 measurements for each lesion) will be presented graphically, grouped by participant and lesion type (acral and non-acral). The dissipation score is the PpIX fluroscence measured after light treatment.
The fluorescence after light treatment will be compared between intervention and control groups with a random effects model. The analysis will be adjusted for baseline fluorescence, grade of lesion, and location of lesion. A change score analysis will be carried out for comparison. |
After data collection is completed, during analysis phase, expected at 12 months. |
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