Photodynamic Therapy Using Topical Aminolevulinic Acid in Treating Patients With Actinic Keratosis
Precancerous/Nonmalignant Condition
About this trial
This is an interventional treatment trial for Precancerous/Nonmalignant Condition focused on measuring actinic keratosis
Eligibility Criteria
DISEASE CHARACTERISTICS:
Actinic keratosis lesion located in any of the following body sites:
Stratum 1*: face and neck, scalp, or upper torso
- At least 1 clinically evident thin actinic keratosis on each side of the midline of any of the above areas
Stratum 2*: arms or legs
- At least 1 clinically evident thick actinic keratosis on each arm or leg NOTE: *One patient may be in one or both strata depending on the location of the lesion(s)
- Lesions to be treated on this protocol must not have been previously treated by other modalities for at least 2 months prior to study entry
PATIENT CHARACTERISTICS:
- No porphyria or known hypersensitivity to porphyrins
- No known photosensitivity disease
- No known sensitivity to any components of aminolevulinic acid topical solution
- Not pregnant or nursing
PRIOR CONCURRENT THERAPY:
- Other concurrent topical therapies at lesion sites other than those used in this protocol are allowed
- No other concurrent photosensitizer drugs
Sites / Locations
- Roswell Park Cancer Institute
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Experimental
Experimental
Experimental
Experimental
Experimental
Arm 1 - ALA
Arm 2
Arm 3
Arm 4
Arm 5
Patients receive topical ALA topical (aminolevulinic acid) 2 hours before PDT.
Patients receive topical ALA topical (aminolevulinic acid) 4 hours before PDT
Patients receive topical ALA (aminolevulinic acid) 24 hours before PDT. Each anatomic area is divided into subunits (e.g., right and left arm, right and left side of the face). The subunits are randomized to receive 1 or 2 pulses of the laser treatment
Vbeam laser pulse (photodynamic therapy) is applied to the subunit
Vbeam laser pulses (photodynamic therapy) are applied to the subunit. Patients may receive up to 3 treatments (including pretreatment, ALA, and PDT) at least 1 month apart