Study Comparing AM001 Cream to Vehicle in the Treatment of Plaque Psoriasis

Inclusion Criteria:

1. Subjects must provide Institutional Review Board (IRB) approved written informed
consent.

2. Subjects must be male or female, at least 18 years of age.

3. Subjects with a definite diagnosis of plaque psoriasis that is clinically active (for
at least 3 months), involving at least 3% and up to 20% of the body surface area (not
including the scalp, face, hands, feet, and intertriginous areas).

4. Subjects with an Investigator's Global Assessment (IGA) of disease severity of at
least moderate severity (score ≥ 3) as an overall assessment.

5. Subjects with a minimum plaque elevation of at least moderate severity (PASI grade ≥
3) at the target lesion site.

6. If females of childbearing potential, the subject must have a negative urine
pregnancy test, and must have been using an acceptable form of birth control for at
least two months prior to Screening and are willing to continue birth control
throughout the study.

7. Subjects must be willing and able to understand and comply with the requirements of
the study, apply the study medication as instructed, return for the required
treatment period visits, comply with therapy prohibitions, and be able to complete
the study.

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

9. Subjects must be willing to limit sun exposure overall. Subjects are prohibited from
sunbathing or intentional tanning or intense sun exposure including the use of
tanning booths/lights or other artificial UV light sources throughout the study.

Exclusion Criteria:

1. Female subjects who are pregnant, nursing, or planning a pregnancy within the study
participation period.

2. Subjects who have a current diagnosis of guttate, pustular, inverse, exfoliative, or
erythrodermic psoriasis.

3. Subjects who have a history of psoriasis unresponsive to topical treatments.

4. Subjects who have a history of a disorder that may interfere with the evaluation of
plaque psoriasis (e.g., atopic dermatitis, contact dermatitis, tinea corporis,
cutaneous lymphoma, etc.).

5. Presence of pigmentation, extensive scarring, or pigmented lesions in the treatment
areas, which could interfere with the rating of efficacy parameters.

6. Subjects with unstable medical disorders, life-threatening disease, or current
malignancies.

7. Subjects with clinically significant ECG or laboratory abnormalities at Screening (as
determined by the Investigator).

8. Subjects who are immunosuppressed.

9. Subjects who have a history of allergy or a known hypersensitivity to any component
of the study medication.

10. Subjects who have been treated with any systemic steroids within the 4 weeks prior to
the study entry.

11. Subjects who have been treated with systemic or photo antipsoriatic therapies/drugs
within 4 weeks prior to study entry including methotrexate, cyclosporine, acitretin
and other oral retinoids, broadband or narrowband UVB, PUVA, home or professional
tanning lights or other nonprescription UV light sources, photodynamic therapy (PDT),
lasers, mycophenalate mofetil (MMF), thioguanine, hydroxyurea, sirolimus,
azathioprine, 6-mercaptopurine (6-MP), or etanercept.

12. Subjects who have been treated with biologic therapy other than etanercept within 8
weeks prior to study entry. Vaccines will not be considered an exclusionary biologic
treatment.

13. Subjects who have been treated with any topical anti-psoriatic (e.g., salicylic acid,
anthralin, tar, etc.,) any topical corticosteroid medications, topical retinoids
(e.g., tazarotene, tretinoin), topical Vitamin D analogs (e.g., calcipotriene),
topical immunosuppressants (e.g., tacrolimus, pimecrolimus) within 2 weeks prior to
study entry.

14. Subjects who have been treated with lithium, antimalarial agents, or quinidine within
the 4 weeks prior to study entry.

15. Subjects who have received radiation therapy and/or anti-neoplastic agents, or taken
any immunosuppressant medication within 3 months prior to study entry.