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



Status:Completed
Conditions:Psoriasis
Therapuetic Areas:Dermatology / Plastic Surgery
Healthy:No
Age Range:18 - Any
Updated:4/17/2018
Start Date:May 16, 2017
End Date:February 13, 2018

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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.

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).

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.
We found this trial at
5
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Carmel, IN
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Albuquerque, NM
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