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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.
Age
6 - 17 years
Sex
ALL
Healthy Volunteers
No
Site 104
Madera, California, United States
Site 108
Santa Ana, California, United States
Investigational Site 102
Hialeah, Florida, United States
Site 109
Hialeah, Florida, United States
Site 107
Overland Park, Kansas, United States
Site 103
St Louis, Missouri, United States
Investigational Site 101
Lincoln, Nebraska, United States
Site 106
Greenville, South Carolina, United States
Site 105
Spokane, Washington, United States
Start Date
May 2, 2017
Primary Completion Date
June 3, 2019
Completion Date
June 3, 2020
Last Updated
March 7, 2024
22
ACTUAL participants
DFD06
DRUG
Lead Sponsor
Primus Pharmaceuticals
Collaborators
NCT07449234
NCT07116967
NCT07250802
Data Source & Attribution
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