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

Psoriasis Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03179605
• Other study ID #: DFD-06-CD-011
• Status: Terminated
• Phase: Phase 2
• Start date: May 2, 2017
• Est. completion date: June 3, 2020

Study information

• Verified date: March 2024
• Source: Primus Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 22
• Est. completion date: June 3, 2020
• Est. primary completion date: June 3, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 17 Years

Eligibility

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

Related Conditions & MeSH terms

• Psoriasis

Intervention

Drug:
• DFD06
Apply twice per day for 15 days

Locations

Country	Name	City	State
United States	Site 106	Greenville	South Carolina
United States	Investigational Site 102	Hialeah	Florida
United States	Site 109	Hialeah	Florida
United States	Investigational Site 101	Lincoln	Nebraska
United States	Site 104	Madera	California
United States	Site 107	Overland Park	Kansas
United States	Site 103	Saint Louis	Missouri
United States	Site 108	Santa Ana	California
United States	Site 105	Spokane	Washington

Sponsors (2)

Lead Sponsor	Collaborator
Primus Pharmaceuticals	Prosoft Clinical

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Subjects With HPA Axis Suppression at Day 15	The percentage of subjects with abnormal cortisol response for ACTH stimulation test at Day 15 (cortisol level =18 µg/dL at 30 minutes post stimulation) is the primary variable	Day 15
Secondary	Number of Participants With Improvement in IGA Grade From Baseline	Numbers of subjects with improvements by at least 1 pint in IGA grade will be provided as descriptive statistics.	Baseline up to Day 15
Secondary	Plasma Concentration of Clobetasol Propionate	Plasma concentrations of clobetasol propionate after multiple doses of DFD-06 under maximal use condition with the final-to-be-marketed formulation.	Day 15 0 hour, 1 hour, 3 hours, 6 hours after application