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

NCT03179605 | Terminated Phase 2 Results FDA Drug

• 1 other identifier: DFD-06-CD-011
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 9

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.

Conditions

Psoriasis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Number of Participants With Improvement in IGA Grade From Baseline

  Baseline up to Day 15

• Plasma Concentration of Clobetasol Propionate

  Day 15 0 hour, 1 hour, 3 hours, 6 hours after application

Study Arms (1)

DFD-06 Cream

EXPERIMENTAL

This is a single arm, open label study and there will be no reference or control product used in this study

Drug: DFD06

Interventions

DFD06 DRUG

Apply twice per day for 15 days

Also known as: clobetasol propionate, Impoyz Cream

DFD-06 Cream

Eligibility Criteria

• Age: 6 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

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

Sponsors & Collaborators

• Primus Pharmaceuticals: lead
• Prosoft Clinical: collaborator

Study Sites (9)

Site 104

Madera, California, 93637, United States

Location

Site 108

Santa Ana, California, 92705, United States

Location

Investigational Site 102

Hialeah, Florida, 33010, United States

Location

Site 109

Hialeah, Florida, 33012, United States

Location

Site 107

Overland Park, Kansas, 66215, United States

Location

Site 103

St Louis, Missouri, 63141, United States

Location

Investigational Site 101

Lincoln, Nebraska, 68522, United States

Location

Site 106

Greenville, South Carolina, 29607, United States

Location

Site 105

Spokane, Washington, 99203, United States

Location

MeSH Terms

Conditions

Psoriasis

Interventions

Clobetasol

Condition Hierarchy (Ancestors)

Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Betamethasone; Steroids, Fluorinated; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Limitations and Caveats

Early termination due to low enrollment with completion of 12 to 16.9 years old group only; the planned 6 to 11.9 years of age did not enroll.

Results Point of Contact

• Title: Robert Babilon President
• Organization: Prosoft Clinical

b.babilon@prosoftclinical.com

4843202068

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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).

Study Record Dates

• First Submitted: May 12, 2017
• First Posted: June 7, 2017
• Study Start: May 2, 2017
• Primary Completion: June 3, 2019
• Study Completion: June 3, 2020
• Last Updated: March 7, 2024
• Results First Posted: June 1, 2022

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (9)