A Study to Evaluate Two Concentrations of DFD-07 Cream, in Subjects With Actinic Keratosis (AK) of the Face and/or Scalp Over a 12-week Treatment Period

Inclusion:

1. Subject understands the study procedures, is willing to comply with the study
procedures and required visits, and agrees to participate by giving written informed
consent. Subjects with a legal guardian, must have the written informed consent of the
legal guardian.

2. Subject (or legal guardian) must be willing to authorize use and disclosure of
protected health information collected for the study.

3. Subjects must have 5 or more AK lesions that are non-hypertrophic and
non-hyperkeratotic, contained within a single contiguous approximately 5 cm x 5 cm (25
cm2) region of face and/or scalp.

4. Subjects must be 18 years of age or older. Male and female subjects can be enrolled.

5. Female subjects of childbearing potential must agree to use contraception during the
study which can include abstinence with an adequate secondary option should the
subject become sexually active. All women of childbearing potential must complete a
urine pregnancy test at the Baseline Visit (Visit 2) and the test result must be
negative to be eligible for enrollment.

A female is considered of childbearing potential unless she is:

1. postmenopausal for at least 12 months prior to study product administration;

2. without a uterus and/or both ovaries; or has been surgically sterile (i.e., tubal
ligation) for at least 6 months prior to study product administration.

Reliable methods of contraception are:

1. hormonal methods or intrauterine device in use more than 90 days prior to study
product administration; or

2. barrier methods plus spermicide in use at least 14 days prior to study product
administration.

3. partner has had a vasectomy at least 3 months previous to study product
administration.

4. Essure

Exception: Sexually inactive female subjects of childbearing potential are not
required to practice a reliable method of contraception and may be enrolled at the
investigator's discretion provided that they are counseled to remain sexually inactive
for the duration of the study and understand the possible risks involved in getting
pregnant during the study. An abstinent female must agree that if she becomes sexually
active during the study she will use an acceptable form of contraception.

6. Subjects must agree not to use any product on the treatment area during the entire
course of study except for Investigator-approved cleanser, sunscreen, wash, and
non-medicated make-up. Subjects should continue to use these Investigator-approved
products for the duration of the study and should avoid any changes in these consumer
products.

7. Subjects must be willing to comply with sun avoidance measures for the face including
use of Investigator-approved sunscreen and/or hats, have limited sun exposure time,
and have no tanning bed use.

8. Subjects must be in good general health as determined by the Investigator and
supported by the medical history, and normal or not clinically significant abnormal
vital signs (blood pressure and pulse rate). Subjects are eligible if:

- Systolic blood pressure (BP) < 160 and > 85 mmHg

- Diastolic BP < 100 and > 50 mmHg

Exclusion:

1. Known or suspected hypersensitivity to any non-steroidal anti-inflammatory drugs
(NSAID) or any component of the formulation of the study medication, including a
history of asthma, urticarial, or other allergic-type reactions after taking aspirin
or other NSAIDs.

2. Known or suspected allergy to sulfonamides.

3. Clinical evidence of severe, uncontrolled autoimmune, cardiovascular,
gastrointestinal, hematological, hepatic, neurologic, pulmonary or renal disease.

4. Recent (within 6 months) or planned coronary artery bypass graft surgery.

5. Significant history (within the past year) of alcohol or drug abuse.

6. Participation in any clinical research study within 30 days of the Baseline Visit.

7. Concomitant use of cosmetics or other topical drug products on or near the selected
treatment area, except for Investigator-approved cleanser, sunscreen, wash, and
non-medicated makeup.

8. Cosmetic or therapeutic procedures (e.g. laser, peeling, photodynamic therapy) within
2 weeks and within 2 cm of the selected treatment area.

9. Other skin conditions within the selected treatment area (e.g. rosacea, psoriasis,
atopic dermatitis, eczema, basal or squamous cell carcinoma or albinism).

10. Any systemic cancer therapy or diagnosis within 6 months of the Baseline Visit.

11. Females who are pregnant or lactating or planning to become pregnant during the study
period.