Duration of Ameluz Application in Acral Actinic Keratoses Response

• Status: Recruiting
• Trial end date: 2022-10-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Royal Cornwall Hospitals Trust
• Treatments: Aminolevulinic Acid

Criteria

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.