Actinic Keratoses
Conditions
Keywords
Actinic Keratoses, Red Light, Photodynamic Therapy, Protoporphyrin IX
Brief summary
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.
Detailed description
This intervention is designed to help establish what the optimal conditions are for treating actinic keratoses with photodynamic therapy (PDT). The primary outcome of this study is to determine whether the rate of singlet oxygen (sO2) production and/or the initial intralesional photosensitize (PpIX) levels, can predict the clinical responsiveness of AK lesions to PDT. Participants will receive standard red light PDT treatment, except that lesions will be carefully counted beforehand. During the window of red light illumination, photos and a video of one area of skin will be taken to allow us to monitor the progress of the treatment. Any remaining lesions will be counted upon follow-up.
Interventions
DRUGTopical Aminolevulinate
Topical Levulan Kerastick is applied to actinic keratoses.
PROCEDUREPhotodynamic therapy (PDT)
PDT is a technique that combines a photosensitizing drug and an intense light source to kill tumor cells.
PROCEDURERed light illumination
To occur post-PTD; used for activation of ALA during photodynamic therapy.
Sponsors
Case Comprehensive Cancer Center
National Cancer Institute (NCI)
National Institutes of Health (NIH)
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Lesion Clearance | 3 months post PDT treatment. | 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 |
| Noninvasive optical measurements of photosensitizer (PpIX) in lesions | 3 months post PDT treatment. | To determine whether the initial level of PpIX can predict the clinical responsiveness of AK lesions to PDT treatment. The clinical responsiveness will be measured by the change in PpIX value before and after red light illumination. |
| Noninvasive optical measurements of singlet oxygen (sO2) in lesions. | 3 months post PDT treatment. | To determine whether the rate of sO2 production can predict the clinical responsiveness of AK lesions to PDT treatment. The clinical responsiveness will be measured by the change in sO2 value before and after red light illumination. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Noninvasive optical measurements variability of photosensitizer (PpIX) in lesions | 3 months post PDT treatment. | To characterize the variability in PpIX production between similarly-sized lesions. This will be measured by the accumulation of PpIX. |
| Noninvasive optical measurements variability of singlet oxygen (sO2) in lesions | 3 months post PDT treatment. | To characterize the variability in sO2 generation between similarly-sized lesions, and to test whether production of sO2 during PDT correlates with the amount of photosensitizer available in AK lesions. This will be measured by sO2 production, measured in real-time by sO2 dosimeter. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATOREdward Maytin, MD, PhD
Cleveland Clinic, Case Comprehensive Cancer Center
Outcome results
None listed