This phase II trial evaluates whether shortening the incubation time (amount of time the medicine sits on the skin prior to being activated by red light) can lower pain levels during photodynamic therapy (PDT) while still effectively treating actinic keratoses (AKs) (skin lesions that have the potential to turn into skin cancer). PDT is a noninvasive light-based therapy Food and Drug Administration (FDA) approved for AKs in which topical agent (called Ameluz or aminolevulinic acid [ALA]) is applied to the skin and then exposed to a particular type of light, in this case red light (BF-RhodoLED). The topical agent, Ameluz, is a preparation containing ALA as its active ingredient. It is applied to the skin as a gel. Exposure to the light targets and kills the AKs. This study may help researchers learn whether shortening the incubation time with ALA gel and red light may reduce pain in patients with AKs undergoing PDT.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT06027619.
PRIMARY OBJECTIVES:
I. To demonstrate that a short-contact PDT protocol with aminolevulinic acid hydrochloride (Ameluz) and red light generates less pain during illumination than the standard FDA-approved protocol currently used.
II. To test the hypothesis that a short-contact PDT protocol with Ameluz and red light will produce lesion clearance outcomes that are statistically non-inferior to the traditional, painful protocol.
SECONDARY OBJECTIVES:
I. To test the hypothesis that a short-contact PDT protocol with Ameluz and red light will generate an inflammatory response.
II. To test the hypothesis that a short-contact PDT protocol with Ameluz and red light will be better tolerated and provide higher patient satisfaction than the currently practiced protocol.
OUTLINE: Patients are randomized to 1 of 3 groups.
GROUP A: Patients receive ALA gel applied topically to the entire face and left for 10 minutes followed by red light illumination over 20 minutes on day 1 and again at 8 weeks. Patients also undergo photography of AK lesions on study.
GROUP B: Patients receive ALA gel applied topically to the entire face and left for 20 minutes followed by red light illumination over 10 minutes on day 1 and again at 8 weeks. Patients also undergo photography of AK lesions on study.
GROUP C: Patients receive ALA gel applied topically to the entire face and left for 60 minutes followed by red light illumination over 10 minutes on day 1 and again at 8 weeks. Patients also undergo photography of AK lesions on study.
After completion of study treatment, patients are followed up at 3-6 months after day 1 of PDT treatment.
Lead OrganizationCase Comprehensive Cancer Center
Principal InvestigatorEdward Maytin
