IRB #

IRB00009517

Title

A Multicenter, Open-label, Phase 1 Study of the Safety, Tolerability, Systemic Exposure, Pharmacodynamics, and Treatment Effect of Calcipotriene Foam, 0.005%, in Pediatric Subjects (Ages 2 to 11 Years) with Plaque Psoriasis

Principal Investigator

Alfons Krol

Study Purpose

The purpose of this study is to learn more about psoriasis in children and how a foam treatment acts on the body and scalp.

Medical Condition(s)

plaque psoriasis

Eligibility Criteria

Male or female children, ages 2 to 11 years, with mild to moderate plaque psoriasis of the face and scalp.

Age Range

2 - 11

Healthy Volunteers Needed

No

Duration of Participation

9 - 13 weeks

Minors Included

Yes

Contact

dermtrials@ohsu.edu
Liz Stoos at 503-418-9386

Sponsor

Mayne Pharma Inc.

Recruitment End

04/28/2018

Compensation Provided

Yes

Compensation

There will be no cost to subjects or their insurance company for study drug, study visits, and tests done for this study. If subjects qualify for the study, they will receive $50 for the screening visit plus $50 for each of the 3 study visits, for a total of $200. If subjects do not complete the study for any reason, they will be paid only for the visits they do complete.


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