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

Primary Purpose

Psoriasis

Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
DFD06
Sponsored by
Encore Dermatology, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Psoriasis

Eligibility Criteria

6 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Site 104
  • Site 108
  • Investigational Site 102
  • Site 109
  • Site 107
  • Site 103
  • Investigational Site 101
  • Site 106
  • Site 105

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

DFD-06 Cream

Arm Description

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.
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.

Full Information

First Posted
May 12, 2017
Last Updated
May 5, 2022
Sponsor
Encore Dermatology, Inc.
Collaborators
Primus Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT03179605
Brief Title
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

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Terminated
Why Stopped
Difficulty in enrollment
Study Start Date
May 2, 2017 (Actual)
Primary Completion Date
June 3, 2019 (Actual)
Study Completion Date
June 3, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Encore Dermatology, Inc.
Collaborators
Primus Pharmaceuticals

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Psoriasis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Sequential Assignment
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)
Allocation
N/A
Enrollment
22 (Actual)

8. Arms, Groups, and Interventions

Arm Title
DFD-06 Cream
Arm Type
Experimental
Arm Description
This is a single arm, open label study and there will be no reference or control product used in this study
Intervention Type
Drug
Intervention Name(s)
DFD06
Other Intervention Name(s)
clobetasol propionate, Impoyz Cream
Intervention Description
Apply twice per day for 15 days
Primary Outcome Measure Information:
Title
Percentage of Subjects With HPA Axis Suppression at Day 15
Description
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
Time Frame
Day 15
Secondary Outcome Measure Information:
Title
Number of Participants With Improvement in IGA Grade From Baseline
Description
Numbers of subjects with improvements by at least 1 pint in IGA grade will be provided as descriptive statistics.
Time Frame
Baseline up to Day 15
Title
Plasma Concentration of Clobetasol Propionate
Description
Plasma concentrations of clobetasol propionate after multiple doses of DFD-06 under maximal use condition with the final-to-be-marketed formulation.
Time Frame
Day 15 0 hour, 1 hour, 3 hours, 6 hours after application

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Site 104
City
Madera
State/Province
California
ZIP/Postal Code
93637
Country
United States
Facility Name
Site 108
City
Santa Ana
State/Province
California
ZIP/Postal Code
92705
Country
United States
Facility Name
Investigational Site 102
City
Hialeah
State/Province
Florida
ZIP/Postal Code
33010
Country
United States
Facility Name
Site 109
City
Hialeah
State/Province
Florida
ZIP/Postal Code
33012
Country
United States
Facility Name
Site 107
City
Overland Park
State/Province
Kansas
ZIP/Postal Code
66215
Country
United States
Facility Name
Site 103
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63141
Country
United States
Facility Name
Investigational Site 101
City
Lincoln
State/Province
Nebraska
ZIP/Postal Code
68522
Country
United States
Facility Name
Site 106
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29607
Country
United States
Facility Name
Site 105
City
Spokane
State/Province
Washington
ZIP/Postal Code
99203
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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

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