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

Completed · Not applicable

Conditions studied: Plaque Psoriasis

In brief

The primary objective of this study is to determine the efficacy and safety of 074-6751 Lotion applied twice daily for four weeks (28 days) in clinical subjects with moderate plaque psoriasis.

Key facts

Study ID

NCT03167515

Run by

Ferndale Laboratories, Inc.

People needed

95

Starts

2017-05-16

Expected to finish

2018-02-13

Last updated by the study team

2018-04-12

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Subject is a male or non-pregnant female and at least 18 years of age.
• Subject has provided written informed consent.
• Females must be post-menopausal, surgically sterile, or using an effective method of birth control.
• Subject has a clinical diagnosis of stable plaque psoriasis.
• 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.
• 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).

You may not qualify if…

• Subject is pregnant, lactating, or is planning to become pregnant during the study.
• Subject has spontaneously improving or rapidly deteriorating plaque psoriasis.
• Subject has guttate, pustular, erythrodermic, or other non-plaque forms of psoriasis.
• 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.
• 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.
• Subject is currently using lithium or Plaquenil.
• 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.
• 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.
• Subject is currently enrolled in an investigational drug or device study.
• Subject has used an investigational drug or investigational device treatment within 30 days prior to first application of the test article.
• Subject has a history of sensitivity to any of the ingredients in the test article.
• Subject is known to be noncompliant or is unlikely to comply with the requirements of the study protocol in the opinion of the investigator.

Where it is running

• Site 03 — Tampa, Florida, United States
• Site 04 — Carmel, Indiana, United States
• Site 05 — Plainfield, Indiana, United States
• Site 02 — Albuquerque, New Mexico, United States
• Site 01 — High Point, North Carolina, United States

Full record on ClinicalTrials.gov

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