A Multicenter Study of 074-6751 Lotion in Subjects With Moderate Plaque Psoriasis

This is an interventional treatment trial for Plaque Psoriasis Read More

Inclusion Criteria:

1. Subject is a male or non-pregnant female and at least 18 years of age.
2. Subject has provided written informed consent.
3. Females must be post-menopausal, surgically sterile, or using an effective method of birth control.
4. Subject has a clinical diagnosis of stable plaque psoriasis.
5. Subject is willing and able to apply the test article as directed, comply with study instructions and commit to all follow-up visits for the duration of the study.
6. Subject, in the investigator's opinion, is in good general health and free of any disease state, skin condition, or physical condition that might impair evaluation of psoriasis, would require use of interfering therapy (e.g., topical, systemic, or surgical).

Exclusion Criteria:

1. Subject is pregnant, lactating, or is planning to become pregnant during the study.
2. Subject has spontaneously improving or rapidly deteriorating plaque psoriasis.
3. Subject has guttate, pustular, erythrodermic, or other non-plaque forms of psoriasis.

4. Subject has used any of the following topical preparations or procedures in the

   Treatment Area:

   • Emollients/moisturizers within four days prior to Visit I;
   • Topical anti-psoriatic drugs on the body (excluding the scalp) within 14 days of Visit 1; or
   • Phototherapy ( including laser), photo-chemotherapy or other forms of photo based therapy for the treatment of their psoriasis within 30 days of Visit 1.

5. Subject has used any of the following systemic medications or procedures:

   • Systemic tofacitinib, ampremilast, methotrexate, retinoids, corticosteroids, and cyclosporine or analogous products with in three months of Visit I; or
   • Systemic anti-inflammatory biologic therapy (i.e., FDA-approved or experimental therapy) with in five half-lives of the biologic prior to Visit 1.
6. Subject is currently using lithium or Plaquenil.
7. Subject is currently using a beta-blocking medication (e.g., propranolol) or angiotensin converting enzyme (ACE) inhibitor at a dose that has not been stabilized, in the opinion of the investigator.
8. Subject, in the opinion of the investigator, has had prolonged exposure to natural or artificial sources of ultraviolet (UV) radiation within 30 days prior to Visit 1 or intends to have such exposure during the study that is likely to modify the subject's disease.
9. Subject is currently enrolled in an investigational drug or device study.
10. Subject has used an investigational drug or investigational device treatment within 30 days prior to first application of the test article.
11. Subject has a history of sensitivity to any of the ingredients in the test article.
12. Subject is known to be noncompliant or is unlikely to comply with the requirements of the study protocol in the opinion of the investigator.