Safety and Efficacy Study Comparing AM001 Cream, 7.5% to Vehicle Cream in the Treatment of Plaque Psoriasis

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 Visit 1/Screening (as determined by the Principal Investigator or designee).
• •8. Subjects who are immunosuppressed.
• •9. Subjects who have a history of allergy or a known hypersensitivity to any component of the investigational product.
• •10. Subjects who have been treated with any systemic steroids within the 4 weeks prior to the study entry (intranasal or inhaled corticosteroids are acceptable if kept constant throughout the study, and intra-articular steroid injections are permissible).
• •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, including adalibumab, infliximab, ustekinumab, golimumab, or rituximab. Vaccines will not be considered an exclusionary biologic treatment.
• •13. Subjects treated with any other biologic agent not listed here for psoriasis or psoriatic arthritis within 12 weeks.
• •14. 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.
• •15. Subjects who have been treated with lithium, antimalarial agents, or quinidine within the 4 weeks prior to study entry.
• •16. Subjects who have received radiation therapy and/or anti-neoplastic agents, or taken any immunosuppressant medication within 3 months prior to study entry.
• •17. Subjects who consume excessive amounts of alcohol, abuse drugs, or have any condition that would compromise compliance, in the investigator's opinion, with this protocol.
• •18. Subjects who have been treated with an investigational drug or investigational device within a period of 30 days prior to study entry, and within 120 days for investigational biologic agent.
• •19. Subjects who have been previously enrolled in this study.