Clinical trial NCT03179605: Assess the Potential for Adrenal Suppression and Systemic Drug Absorption Following Multiple Dosing With DFD-06
Official title: 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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Psoriasis
Lead sponsor: Primus Pharmaceuticals
Sponsor class: INDUSTRY
Collaborators: name: Prosoft Clinical
First posted: 2017-06-07
Enrollment: 22
Sex: ALL
Minimum age (years): 6
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SEQUENTIAL
Intervention model description: 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).
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Percentage of Subjects With HPA Axis Suppression at Day 15
timeFrame: Day 15
Secondary outcomes:
measure: Number of Participants With Improvement in IGA Grade From Baseline
timeFrame: Baseline up to Day 15
measure: Plasma Concentration of Clobetasol Propionate
timeFrame: Day 15 0 hour, 1 hour, 3 hours, 6 hours after application
Other outcomes:
Locations:
city: Madera
country: United States
facility: Site 104
state: California
city: Santa Ana
country: United States
facility: Site 108
state: California
city: Hialeah
country: United States
facility: Investigational Site 102
state: Florida
city: Hialeah
country: United States
facility: Site 109
state: Florida
city: Overland Park
country: United States
facility: Site 107
state: Kansas
city: Saint Louis
country: United States
facility: Site 103
state: Missouri
city: Lincoln
country: United States
facility: Investigational Site 101
state: Nebraska
city: Greenville
country: United States
facility: Site 106
state: South Carolina
city: Spokane
country: United States
facility: Site 105
state: Washington
Study officials:
References: