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

NCT03167515 | Completed FDA Device

• 1 other identifier: 074-6751-001
• Study Type: interventional
• Target: 95
• Locations: 1 country
• Sites: 5

Brief Summary

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.

Conditions

Plaque Psoriasis

Outcome Measures

Primary Outcomes (1)

• Change from Baseline in sum of clinical signs of psoriasis (scaling, erythema, and plaque elevation) scores.

  Scaling, erythema and plaque elevation will each be scored on a 5-point scale where 0 = clear, 1 = almost clear, 2 = mild, 3 = moderate, and 4 = severe. These evaluations are an assessment of the overall or "average" degree of each of three key characteristics present within all of the subject's psoriatic lesions in the Treatment Area by the investigator or designee.

  Day 29

Secondary Outcomes (2)

• The proportion of subjects with improvement versus Baseline in IGA score.

  Day 29

• The proportion of subjects with improvement versus Baseline for each of the clinical signs of psoriasis (scaling, erythema and plaque elevation)

  Day 29

Study Arms (1)

074-6751 Lotion

EXPERIMENTAL

Device: 074-6751 Lotion

Interventions

074-6751 Lotion DEVICE

Apply lotion once in the morning and once in the evening daily at approximately the same time every day with 12 hours between doses. Apply the lotion only to the active psoriatic lesions, as instructed by your study doctor.

074-6751 Lotion

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• Ferndale Laboratories, Inc.: lead

Study Sites (5)

Site 03

Tampa, Florida, 33618, United States

Location

Site 04

Carmel, Indiana, 46032, United States

Location

Site 05

Plainfield, Indiana, 46168, United States

Location

Site 02

Albuquerque, New Mexico, 87106, United States

Location

Site 01

High Point, North Carolina, 27262, United States

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 24, 2017
• First Posted: May 30, 2017
• Study Start: May 16, 2017
• Primary Completion: November 28, 2017
• Study Completion: February 13, 2018
• Last Updated: April 12, 2018

Record last verified: 2018-04

Locations

US (5)