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

NCT ID: NCT03167515

Last Updated: 2018-04-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 95 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-05-16
• Study Completion Date: 2018-02-13

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.

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).

Conditions

Plaque Psoriasis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

074-6751 Lotion

Group Type: EXPERIMENTAL

074-6751 Lotion

Intervention Type: 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.

Interventions

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.

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Ferndale Laboratories, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

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

Countries

United States

Other Identifiers

074-6751-001

Identifier Type: -

Identifier Source: org_study_id