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

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ClinicalTrials.gov Identifier: NCT03179605
Recruitment Status : Recruiting
First Posted : June 7, 2017
Last Update Posted : January 17, 2018
Sponsor:
Information provided by (Responsible Party):
Promius Pharma, LLC

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.

Condition or disease Intervention/treatment Phase
Psoriasis Drug: DFD06 Phase 2

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Intervention Model: Sequential Assignment
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).
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : May 2, 2017
Estimated Primary Completion Date : May 31, 2018
Estimated Study Completion Date : May 31, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Psoriasis

Arm Intervention/treatment
Experimental: DFD-06 Cream
This is a single arm, open label study and there will be no reference or control product used in this study
Drug: DFD06
Apply twice per day for 15 days




Primary Outcome Measures :
  1. Proportion of subjects with HPA axis suppression at Day 15 [ Time Frame: Day 15 ]
    The proportion 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


Secondary Outcome Measures :
  1. Change in IGA grade [ Time Frame: Baseline up to Day 15 ]
    IGA grades will be recorded at all visits and provided as descriptive statistics to show change from Baseline.



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Ages Eligible for Study:   6 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03179605


Locations
United States, California
Site 104 Recruiting
Madera, California, United States, 93637
Contact: Carmela Fritz    609-375-9929    cfritz@promiuspharma.com   
Site 108 Recruiting
Santa Ana, California, United States, 92705
Contact: Carmela Fritz    609-375-9929    cfritz@promiuspharma.com   
United States, Florida
Investigational Site 102 Recruiting
Hialeah, Florida, United States, 33010
Contact: Carmela Fritz    609-375-9929    cfritz@promiuspharma.com   
Site 109 Recruiting
Hialeah, Florida, United States, 33012
Contact: Carmela Fritz    609-375-9929    cfritz@promiuspharma.com   
United States, Kansas
Site 107 Recruiting
Overland Park, Kansas, United States, 66215
Contact: Carmela Fritz    609-375-9929    cfritz@promiuspharma.com   
United States, Missouri
Site 103 Recruiting
Saint Louis, Missouri, United States, 63141
Contact: Carmela Fritz    609-375-9929    cfritz@promiuspharma.com   
United States, Nebraska
Investigational Site 101 Recruiting
Lincoln, Nebraska, United States, 68522
Contact: Carmela Fritz    609-375-9929    cfritz@promiuspharma.com   
Principal Investigator: PI Site 1, MD         
United States, South Carolina
Site 106 Recruiting
Greenville, South Carolina, United States, 29607
Contact: Carmela Fritz    609-375-9929    cfritz@promiuspharma.com   
United States, Washington
Site 105 Recruiting
Spokane, Washington, United States, 99203
Contact: Greg Jared    509-381-1972    greg@principleresearchsolutions.com   
Principal Investigator: Katherine Reed, MD         
Sponsors and Collaborators
Promius Pharma, LLC

Responsible Party: Promius Pharma, LLC
ClinicalTrials.gov Identifier: NCT03179605     History of Changes
Other Study ID Numbers: DFD-06-CD-011
First Posted: June 7, 2017    Key Record Dates
Last Update Posted: January 17, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases