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

Stopped early · Phase 2

Conditions studied: Psoriasis

In brief

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.

Key facts

Study ID

NCT03179605

Run by

Primus Pharmaceuticals

People needed

22

Starts

2017-05-02

Expected to finish

2020-06-03

Last updated by the study team

2024-03-07

Who can join

Age: 6 and older, up to 17. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• 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

Full record on ClinicalTrials.gov

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