Assess the Potential for Adrenal Suppression and Systemic Drug Absorption Following Multiple Dosing With DFD-06



Status:Recruiting
Conditions:Psoriasis
Therapuetic Areas:Dermatology / Plastic Surgery
Healthy:No
Age Range:6 - 17
Updated:2/17/2019
Start Date:May 2, 2017
End Date:June 30, 2019

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An Open Label, Multicenter Study to Assess the Potential for Adrenal Suppression and Systemic Drug Absorption Following Multiple Dosing With DFD-06 in Pediatric Subjects With Moderate to Severe Plaque Psoriasis

The purpose of this study is to evaluate the potential of DFD-06 to suppress the
hypothalamic-pituitary-adrenal (HPA) axis when applied twice daily for 15 days.

This is a 15-day, single arm, multicenter, multi-dose, open-label, two stage, sequential
study. In the first stage, subjects who are at least 12 years of age and not more than 16.9
years (16 years and 11 months) of age with moderate to severe plaque psoriasis will be
treated with DFD-06 (at least 20 completed subjects). In the second stage subjects who are at
least 6 years of age and not more than 11.9 years (11 years and 11 months) of age with
moderate to severe plaque psoriasis will be treated with DFD-06 (at least 20 completed
subjects). An attempt will be made to enroll subjects throughout the age range of each cohort
including the lower age range. DFD-06 will be applied twice daily to all affected areas on
the body excluding face, scalp, groin, axillae and other intertriginous areas. Subjects must
have ≥10% Body Surface Area (BSA) treated to achieve maximal use exposure.

Inclusion Criteria:

- Subjects and the parent or legal guardian understand the study procedures and agree to
participate by giving assent and written informed consent, respectively. Subject's
parent or legal guardian must be willing to authorize use and disclosure of protected
health information collected for the study.

- Subjects must be at least 6 years and not more than 16.9 years of age, with body
weight greater than or equal to 45 pounds at Screening.

- Subjects must present with a clinical diagnosis of stable (at least 3 months) plaque
psoriasis.

- Subjects with psoriasis involving ≥10% Body Surface Area (BSA), not including the
face, scalp, groin, axillae and other intertriginous areas at the Baseline Visit.

- Subjects must have an Investigator Global Assessment (IGA) grade of at least 3
(moderate) at the Baseline Visit.

Exclusion Criteria:

- Subject has a current diagnosis of unstable forms of psoriasis including guttate,
erythrodermic, exfoliative or pustular psoriasis.

- Subject has a history of organ transplant requiring immunosuppression, HIV, or other
immunocompromised state.

- Subject has received treatment for any type of cancer within 5 years of the Baseline
Visit except skin cancer and cervical cancer (in situ) are allowed if at least 1 year
before the Baseline Visit.

- Subject has a history or presence of intracranial hypertension.

- Subject has had prolonged exposure to natural or artificial sources of ultraviolet
radiation within 30 days prior to the initiation of treatment or is intending to have
such exposure during the study that is thought by the investigator to likely modify
the subject's disease
We found this trial at
8
sites
Lincoln, Nebraska 68515
Principal Investigator: PI Site 1, MD
Phone: 858-571-1800
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Lincoln, NE
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Greenville, South Carolina 29605
Phone: 858-571-1800
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Greenville, SC
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Hialeah, Florida
Phone: 858-571-1800
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Hialeah, FL
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Madera, California 93637
Phone: 858-571-1800
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Madera, CA
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Overland Park, Kansas
Phone: 858-571-1800
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Overland Park, KS
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Saint Louis, Missouri 63110
Phone: 858-571-1800
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Saint Louis, MO
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Santa Ana, California 92701
Phone: 858-571-1800
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Santa Ana, CA
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Spokane, Washington
Principal Investigator: Katherine Reed, MD
Phone: 509-381-1972
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Spokane, WA
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