A Comparison of 122-0551 Foam Versus Vehicle Foam in Subjects With Plaque Psoriasis (Study 310)



Status:Completed
Conditions:Psoriasis
Therapuetic Areas:Dermatology / Plastic Surgery
Healthy:No
Age Range:18 - Any
Updated:11/16/2018
Start Date:June 2016
End Date:June 16, 2017

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A Multicenter, Randomized, Double-Blind, Parallel Group Comparison of 122-0551 Foam Versus Vehicle Foam in Subjects With Plaque Psoriasis (Study 310)

This Phase 3 study (Study 310) has been designed to determine and compare the efficacy and
safety of 122-0551 Foam and Vehicle Foam applied twice daily for two weeks in subjects with
plaque psoriasis.


Inclusion Criteria:

1. Subject is male or non-pregnant female and is at least 18 years of age at the time of
the Screening Visit.

2. Subject has provided written informed consent.

3. Subject is willing and able to apply the test article(s) as directed, comply with
study instructions and commit to all follow-up visits for the duration of the study.

4. Subject has a clinical diagnosis of stable plaque psoriasis involving a minimum of 2%
and no more than 12% body surface area (BSA) (excluding the face, scalp, groin,
axillae and other intertriginous areas).

5. Subject has an Investigator's Global Assessment (IGA) score of at least three (3 =
moderate) at the Baseline Visit.

6. Females must be post-menopausal , surgically sterile or use an effective method of
birth control , with a negative urine pregnancy test (UPT) at the Baseline Visit.

Exclusion Criteria:

1. Subject has spontaneously improving or rapidly deteriorating plaque psoriasis.

2. Subject has guttate, pustular, erythrodermic or other non-plaque forms of psoriasis.

3. Subject has a physical condition which, in the investigator's opinion, might impair
evaluation of plaque psoriasis, or which exposes the subject to an unacceptable risk
by study participation.

4. Subject has used any phototherapy (including laser), photo-chemotherapy or other forms
of photo based therapy for the treatment of their psoriasis within 30 days prior to
the Baseline Visit.

5. Subject has used any systemic methotrexate, retinoids, systemic corticosteroids
[including intralesional, intra-articular, and intramuscular corticosteroids],
cyclosporine or analogous products within 90 days prior to the Baseline Visit.

6. Subject has used any systemic biologic therapy (i.e., FDA-approved or experimental
therapy) within five (5) half-lives of the biologic prior to the Baseline Visit.
Published or documented half-life of the product provided by the commercial supplier
or Sponsor should be used to establish this value.

7. Subject had prolonged exposure to natural or artificial sources of ultraviolet
radiation within 30 days prior to the Baseline Visit or is intending to have such
exposure during the study which in the opinion of the investigator is thought to
modify the subject's disease.

8. Subject has used topical body (excluding the scalp) psoriasis therapy (including coal
tar, anthralin, steroids, retinoids and vitamin D analogs) within 14 days prior to the
Baseline Visit.

9. Subject has used emollients/moisturizers on areas to be treated within four hours
prior to clinical evaluation at the Baseline Visit.

10. Subject is currently using lithium or Plaquenil (hydroxychloroquine).

11. 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.

12. Subject has a history of sensitivity to any of the ingredients in the test articles.

13. Subject is pregnant, lactating, or is planning to become pregnant during the study.

14. Subject is currently enrolled in an investigational drug or device study.

15. Subject has used an investigational drug or investigational device treatment within 30
days prior to the Baseline Visit.

16. Subject has been previously enrolled in this study and treated with a test article.

17. Subject is known to be noncompliant or is unlikely to comply with the requirements of
the study protocol (e.g., due to alcoholism, drug dependency, mental incapacity) in
the opinion of the investigator.
We found this trial at
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Fort Smith, Arkansas 72901
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Gahanna, Ohio 43230
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Pinellas Park, Florida
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Quincy, Massachusetts 62301
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Spokane, Washington
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Wilmington, North Carolina 28401
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