Cryotherapy in Combination with Red Light PDT for Actinic Keratosis of Full Face

Inclusion Criteria:

1. Male or female adult ≥ 18 years of age;

2. 6-12 actinic keratosis grade I, II, and III on the full face.

3. Willing to avoid excessive sunlight or ultraviolet (UV) light exposure, includingthe use of tanning beds, to the face or scalp during study participation.

4. Females of childbearing potential (FCBP) must have a negative serum pregnancy testat Screening and negative urine pregnancy test at Baseline. FCBP who engage inactivity in which conception is possible must use one of the approved contraceptiveoptions: hormonal contraception; intrauterine device (IUD); tubal ligation; orpartner's vasectomy; Male or female condom diaphragm with spermicide, cervical capwith spermicide, or contraceptive sponge with spermicide.

5. Able and willing to give written informed consent prior to performance of anystudy-related procedures

Exclusion Criteria:

1. Presence of other skin conditions that may affect the study participant,investigator's ability to assess treatment, or intolerance to any ingredient in 10%ALA gel.

2. Treatment with 5-fluorouracil (5-FU), imiquimod, ingenol mebutate, diclofenac,photodynamic therapy, or other topicals and treatments for AK within the treatmentarea or within 2 cm of the treatment area, within 12 weeks of baseline.

3. Use of liquid nitrogen, excision, curettage, dermabrasion, chemical peel or laserresurfacing in the treatment area within 60 days.

4. Use of systemic retinoids (eg, isotretinoin, acitretin) within 6 months

5. Women of childbearing potential who are pregnant, intend to become pregnant, or arelactating.

6. Use of any investigational drug within 4 weeks prior to enrollment or within 5pharmacokinetic/pharmacodynamic half-lives, if known (whichever is longer).

7. Any clinically significant (as determined by the Investigator) cardiac,endocrinologic, pulmonary, neurologic, psychiatric, hepatic, renal, hematologic,immunologic disease, or other major disease that is currently uncontrolled.