Safety and Efficacy Study of AM001 Cream in the Treatment of Actinic Keratosis

A Phase 2, Single-Center, Randomized, Double- Blind, Parallel-Group, Vehicle-Controlled Study
Evaluating the Efficacy and Safety of AM001 Cream in the Treatment of Actinic Keratosis (AK)
Lesions

Inclusion Criteria:

1. Subject must provide written informed consent.

2. Subject must be male or non-pregnant females of any race, and any skin type aged 18 to
80 years both inclusive.

3. Subject has 4 to 8 clinically typical, visible, discrete, nonhyperkeratotic,
nonhypertrophic AK lesions, each at least 4 mm in diameter within a 25cm² contiguous
treatment area on the face or the balding scalp.

4. Subject is willing to avoid exposure to sunlight, use of tanning booths, sunlamps, or
nonprescription UV (ultra-violate) light sources during the study period.ooths,
sunlamps, or nonprescription UV (ultra-violate) light sources during the study period.

5. If female subject of childbearing potential, the subject must have a negative urine
pregnancy test at Visit 1/ Screening and must have been using an acceptable form of
birth control for at least 2 months prior to Visit 1/ Screening and is willing to
continue birth control during the study.

6. Subject must be willing and able to understand and comply with the requirements of the
study, apply the assigned investigational product as instructed, return for the
required study visits, comply with therapy prohibitions.

7. Subject must be in good health, as confirmed by medical history and physical exam, and
free from any clinically significant disease/condition, other than actinic keratosis,
that might interfere with the study evaluations.

Exclusion Criteria:

1. Subject has very thick and/or hyperkeratotic actinic keratosis AK lesions in the
treatment area.

2. Subject has used topical treatment of actinic keratosis in the treatment area with
5-fluorouracil, imiquimod, diclofenac, corticosteroids or retinoids within 1 month
prior to Visit 2/Baseline or during the study.

3. Subject has used treatment with PDT (photodynamic therapy) or physical therapies (e.
g. cryotherapy, curettage or surgical treatment) in the treatment area within 1 month
prior to Visit 2/Baseline or during the study.

4. Subject has used chemical peel, dermabrasion, laser abrasion, PUVA (prosalen plus
ultraviolet A) therapy or UVB therapy within 6 months prior to Visit 2/Baseline or
during the study.

5. Subject has used immunomodulators or immunosuppressive therapies, interferon, oral
corticosteroids, oral retinoids or cytotoxic drugs within 1 month prior to Visit
2/Baseline or during the study.

6. Subject has untreated basal cell carcinoma, squamous cell carcinoma or melanoma in the
treatment area.

7. Subject has suntan or tattoos that may interfere with the assessments in the treatment
area.

8. Subject has dermatological diseases in the treatment area that may interfere with the
assessments, e.g. acute skin inflammation, atopic dermatitis, eczema, rosacea,
psoriasis, seborrheic dermatitis, peri-oral dermatitis or hyperpigmentation.

9. Subject who consumes excessive amount of alcohol, abuse or have any condition that in
the investigator's opinion would compromise compliance, with this protocol.

10. Subject has history of malignancy not in remission for at least 5 years excluding
basal cell carcinoma and nonperiorificial squamous cell carcinoma of the skin.

11. Female subject who is pregnant, nursing or planning a pregnancy within the study
participation period

12. Subject has symptoms of a clinically significant illness that may influence the
outcome of the study in the 4 weeks prior to Visit 1/Screening.

13. Subject has participated in another clinical trial involving investigational product
or device in the 4 weeks prior to Visit 1/Screening.

14. Subject has known allergic reactions to components of the investigational product.