Study to Evaluate the Long-Term Safety of IDP-118 Lotion in the Treatment of Plaque Psoriasis

Therapuetic Areas:Dermatology / Plastic Surgery
Age Range:18 - Any
Start Date:September 2015
End Date:September 2016
Contact:Laura Donohue

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(V01-118A-03) A Phase 3, Multicenter, Open-Label Study to Evaluate the Long-Term Safety of IDP-118 Lotion in the Treatment of Plaque Psoriasis

The objective of this study is to evaluate the long-term safety of topical IDP-118 lotion
following once daily, 8-week treatment courses in subjects with plaque psoriasis followed by
intermittent as needed treatment for up to 1-year. Subjects will receive treatment courses
as needed during the year to manage their plaques psoriasis with following safety endpoint
evaluations being conducted.

Eligible male and female participants must be greater than or equal to 18 years old, have an
area of plaque Psoriasis, and not be, or plan to be, pregnant or breast feeding during the
study. Subjects must be available for at least 7 office visits during the 17 week period and
be willing to comply with all study instructions. Several other restrictions and criteria
may apply that the study doctor will review with you to determine if you qualify to enter
the study.

The subject will be instructed on how to treat the affected areas. Subjects will be
instructed to squeeze a small amount of study drug (pea-sized) onto a fingertip and then
spread a thin layer of the study drug over the affected area once daily up to week 8. The
in-office study visits will be approximately 2 weeks apart and include assessment of the
psoriasis-affected body surface area, as well as periodic small blood draws.

This is a multicenter, open-label study of the long-term safety of IDP-118 lotion in
subjects with plaque psoriasis. This means it is not approved by the FDA, but that it can be
tested in research studies like this one. IDP-118 lotion is a combination product,
containing halobetasol propionate 0.01% and tazarotene 0.045%, both separately FDA approved
and available for the treatment of plaque psoriasis.

Inclusion criteria:

1. Male or female, of any race, at least 18 years of age.

2. Freely provides both verbal and written informed consent.

3. Has an area of plaque psoriasis appropriate for topical treatment that covers a body
surface area of at least 3%, but no more than 12%. The face, scalp, palms, soles,
axillae, and intertriginous areas are to be excluded from this calculation.

4. Is willing and able to avoid prolonged exposure of the treatment area to ultraviolet
radiation (natural and artificial) for the duration of the study.

5. Has a clinical diagnosis of psoriasis.

6. Is in good general health based on the subject's medical history and a physical
examination, with screening hematology and serum chemistry laboratory values within
normal range or not clinically significant as determined by the investigator.

7. If female and of childbearing potential, must have negative urine and serum pregnancy
tests at the Screening visit and a negative urine pregnancy test at the Baseline

8. If female, is either not of childbearing potential, defined as postmenopausal for at
least 12 months or surgically sterile (bilateral tubal ligation, bilateral
oophorectomy, or hysterectomy), or is of childbearing potential and practicing an
acceptable method of birth control throughout the study.

9. Subject is willing to comply with study instructions and return to the clinic for
required visits

Exclusion criteria:

1. Has spontaneously improving or rapidly deteriorating plaque psoriasis or pustular
psoriasis, as determined by the investigator.

2. Presents with psoriasis that was treated with prescription medication and failed to
respond to treatment, even partially or temporarily, as determined by the

3. Presents with any concurrent skin condition that could interfere with the evaluation
of the treatment areas, as determined by the investigator.

4. Is pregnant, nursing an infant, or planning a pregnancy during the study period.

5. Has received treatment with any investigational drug or device within 60 days or 5
drug half-lives (whichever is longer) prior to the Baseline visit, or is concurrently
participating in another clinical study with an investigational drug or device.

6. Received treatment with any topical antipsoriatic drug product within 14 days prior
to the Baseline visit.

7. Has used any phototherapy (including laser), photochemotherapy, or systemic psoriasis
therapy (such as systemic corticosteroids, methotrexate, retinoids, or cyclosporine)
within 4 weeks prior to the Baseline visit.

8. Has used immunomodulatory therapy (biologics) known to affect psoriasis within 3
months of the Baseline visit.

9. Has had prolonged exposure to natural or artificial sources of ultraviolet radiation
within 4 weeks prior to the Screening visit or is intending to have exposure during
the study thought likely by the investigator to modify the subject's psoriasis.

10. Is currently using lithium or Plaquenil.

11. Has a history of hypersensitivity or allergic reaction to any of the study drug

12. Is unable to be compliant with study procedures, study drug administration
requirements, study visit schedules, and prohibitions regarding the use of
concomitant medications/therapies.

13. Is unable to communicate or cooperate with the investigator.

14. Has any underlying disease (e.g., uncontrolled diabetes, cardiac disease) that the
investigator deems uncontrolled that poses a concern for the subject's safety while
participating on the study.

15. Has a history of drug or alcohol abuse.

16. Is considered by the investigator, for any other reason, to be an unsuitable
candidate for the study.
We found this trial at
911 Park Avenue
New York, New York 10075
Phone: 212-772-7242
New York, NY
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