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

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.

Study Overview

• Status: Completed
• Conditions: Plaque Psoriasis
• Intervention / Treatment: Device: 074-6751 Lotion

Detailed Description

Skin diseases that cause swelling like psoriasis can be improved by using products applied to cover the skin, keeping the skin moist. Keeping the skin moist will ease the local signs and symptoms, such as skin redness, scaling, and itching in patients with plaque psoriasis. Researchers are testing 074-6751 Lotion in clinical subjects with moderate plaque psoriasis to see if it can act as a protective barrier for the skin so the skin remains moist and heals over time.

074-6751 Lotion is an investigational device. Eligible clinical subjects will be enrolled in the study and apply 074-6751 Lotion twice daily to all psoriasis plaques in the assigned Treatment Area for 28 days. Efficacy will be assessed in the Treatment Area by Investigator's Global Association (IGA) score, clinical signs of psoriasis, pruritus, and percent BSA affected. Safety will be assessed by adverse events (AEs).

• Study Type: Interventional
• Enrollment (Actual): 95
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Tampa, Florida, United States, 33618
      • Site 03
  • Indiana
    • Carmel, Indiana, United States, 46032
      • Site 04
    • Plainfield, Indiana, United States, 46168
      • Site 05
  • New Mexico
    • Albuquerque, New Mexico, United States, 87106
      • Site 02
  • North Carolina
    • High Point, North Carolina, United States, 27262
      • Site 01

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 074-6751 Lotion	Device: 074-6751 Lotion; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
The proportion of subjects with improvement versus Baseline in IGA score.	The Investigator's Global Assessment (IGA) will be assessed on a 5-point scale where 0 = clear, 1 = almost clear, 2 = mild, 3 = moderate, and 4 = severe.	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

Collaborators and Investigators

• Sponsor: Ferndale Laboratories, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): May 16, 2017
• Primary Completion (Actual): November 28, 2017
• Study Completion (Actual): February 13, 2018

Study Registration Dates

• First Submitted: May 24, 2017
• First Submitted That Met QC Criteria: May 24, 2017
• First Posted (Actual): May 30, 2017

Study Record Updates

• Last Update Posted (Actual): April 12, 2018
• Last Update Submitted That Met QC Criteria: April 11, 2018
• Last Verified: April 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Skin Diseases, Papulosquamous; Psoriasis
• Other Study ID Numbers: 074-6751-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No