Clinical trial · Interventional
Imaging Techniques to Monitor Photosensitizer and sO2 Levels During Photodynamic Therapy of Actinic Keratoses
Noninvasive Imaging Techniques to Monitor Photosensitizer and Singlet Oxygen Levels During Photodynamic Therapy of Actinic Keratoses
NCT05923060CI-TRIAL-00103782completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of the study is to test a new video device for actinic keratoses. The device takes images of your skin lesions during the treatment, to learn whether this device can predict how well the treatment is working.
Conditions
Conditions (1)
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 | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Photodynamic therapy (PDT) | Procedure | — | UNRESOLVED |
| Red light illumination | Procedure | — | UNRESOLVED |
| Topical Aminolevulinate | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Standard PDT + topical aminolevulinate + red light illumination
- description
- Standard PDT using topical aminolevulinate followed by red light illumination for actinic keratosis. A region of interest (ROI) on the skin of the arms, hands, legs, or feet will be selected for monitoring. This ROI will be marked and baseline measurements will be taken. The topical drug Levulan (ALA) will be applied to the ROI and other areas being treated, and covered with plastic wrap. Prior to red light illumination, post topical measurements and baseline values will be performed to measure PpIX and sO2. Red light illumination will follow, and sO2 phosphorescence will be recorded continuously from the ROI. After, a post-PpIX measurement will be taken.
- interventionNames
- Drug: Topical Aminolevulinate
- Procedure: Photodynamic therapy (PDT)
- Procedure: Red light illumination
Primary outcomes (3)
- measure
- Lesion Clearance
- timeFrame
- 3 months post PDT treatment.
- description
- Based on the rate of sO2 production, and/or the initial level of PpIX, is significantly correlated with the clinical responsiveness of AK lesions to PDT treatment. The clinical responsiveness will be measured by the decrease in the number of lesions
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Participants of at least 18 years of age, with at least 10 AK lesions on the arms or legs, and with two AK lesions close enough to be seen together within a selected region of interest. * Female participants must not become pregnant during the study. The effects of 5-aminolevulinic acid (LevulanTM) on the human fetus are unknown. For this reason, participants of child-bearing potential must agree to use contraception. However, we note here that the vast majority of participants with chronic sun-induced AK lesions are beyond the age of menopause. * Participants must be able to understand and willing to sign a written informed consent document. Exclusion Criteria: * Pregnant or nursing. * Using any topical treatment on their AKs; must stop at least one month prior. * Currently undergoing treatment for other cancers with medical or radiation therapy. * Participants with a known hypersensitivity to 5-aminolevulinic acid or any component of the study material. * Participants with history of a photosensitivity disease, such as porphyria cutanea tarda.
References
Publications (0)
Data not yet available
No reference posted for this study.