Clinical trial · Interventional
Duration of Ameluz Application in Acral Actinic Keratoses Response
A Study to Investigate the Effect of Different Durations of Ameluz Application on Response to Treatment of Acral Actinic Keratoses
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): 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.
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Actinic Keratoses | — | UNRESOLVED | — |
| Photodamaged Skin | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Ameluz | Drug | 5-Aminolevulinic Acid | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Control Group 3 hours
- description
- Application of Ameluz for 3 hours.
- interventionNames
- Drug: Ameluz
- type
- EXPERIMENTAL
- label
- Trial Group 4 hours
- description
- Application of Ameluz for 4 hours.
- interventionNames
- Drug: Ameluz
Primary outcomes (1)
- measure
- 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).
- timeFrame
- 3 months
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available