A Single Center, Observational Study to Evaluate the Effectiveness and Safety of Cryotherapy in Combination with 10% ALA Gel Red Light PDT in the Treatment of Actinic Keratosis on the Full Face.
40 patients randomized 1:1 to receive cryotherapy followed by 10% ALA gel Red light PDT vs. to 10% ALA gel Red Light PDT followed by cryotherapy.
• Male or female adult ≥ 18 years of age;
• 6-12 actinic keratosis grade I, II, and III on the full face.
• Willing to avoid excessive sunlight or ultraviolet (UV) light exposure, including the use of tanning beds, to the face or scalp during study participation.
• Females of childbearing potential (FCBP) must have a negative serum pregnancy test at Screening and negative urine pregnancy test at Baseline. FCBP who engage in activity in which conception is possible must use one of the approved contraceptive options: hormonal contraception; intrauterine device (IUD); tubal ligation; or partner's vasectomy; Male or female condom diaphragm with spermicide, cervical cap with spermicide, or contraceptive sponge with spermicide.
• Able and willing to give written informed consent prior to performance of any study-related procedures