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DFD01 Spray HPA Axis Suppression Study in Adolescent Patients With Moderate to Severe Plaque Psoriasis

Primary Purpose

Plaque Psoriasis

Status
Terminated
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
DFD01 Spray
Sponsored by
Encore Dermatology, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Plaque Psoriasis

Eligibility Criteria

12 Years - 16 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Subjects must weigh at least 55 pounds
  2. Subjects must present with a clinical diagnosis of stable (at least 3 months) plaque psoriasis.
  3. Subjects with psoriasis involving ≥ 10% BSA, not including the face, scalp, groin, axillae and other intertriginous areas..
  4. Subjects must have moderate to severe plaque psoriasis at the Baseline Visit.
  5. Subjects whose results from the screening ACTH stimulation test are considered normal (cortisol level >18 ug/dL at 30 minutes post stimulation) and show no other signs of abnormal HPA axis function or adrenal response.

Exclusion Criteria:

  1. Current diagnosis of unstable forms of psoriasis including guttate, erythrodermic, exfoliative or pustular psoriasis.
  2. History of organ transplant requiring immunosuppression, HIV, or other immunocompromised state.
  3. Have received treatment for any type of cancer within 5 years of the Baseline Visit.
  4. Use within 60 days prior to the Baseline Visit of: 1) immunosuppressive drugs (e.g., tacrolimus, pimecrolimus), 2) systemic antipsoriatic treatment (e.g., methotrexate, cyclosporine, hydroxyurea), or 3) biologic treatment for psoriasis (e.g., infliximab, adalimumab, etanercept, ustekinumab, secukinumab, or alefacept).
  5. Use within 30 days prior to the Baseline Visit of: 1) topical antipsoriatic drugs (salicylic acid, anthralin, coal tar, calcipotriene), 2) PUVA therapy, 3) systemic anti-inflammatory agents (e.g., mycophenolate mofetil, sulfasalazine, 6-thioguanine), or 4) UVB therapy.
  6. Use within 30 days prior to the Screening Visit of any product containing corticosteroids. Inhaled, intraocular, intranasal, etc. steroids are not allowed.
  7. Subjects who have an abnormal sleep schedule or work overnight.
  8. Subjects with a known history of acute adrenal crisis, Addison's disease or decreased adrenal output, low pituitary function or pituitary tumors.
  9. Subjects who have a history of an adverse reaction to cosyntropin injection or similar test reagents.

Sites / Locations

  • Site 102
  • Site 104
  • Site 100
  • Site 109
  • Site 107
  • Site 106
  • Site 101
  • Site 105

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

DFD01 Spray Group 1

DFD01 Spray Group 2

Arm Description

DFD01 spray, twice daily, 15 days

DFD01 spray, twice daily, 29 days

Outcomes

Primary Outcome Measures

Participants With HPA Axis Suppression at End of Treatment (Day 15 or Day 28) With Recovery 29 Days Later
Number of participants with HPA axis suppression at End of Treatment (day 15 or day 28) with recovery 29 days later, by measuring the level of cortisol in the blood after ACTH stimulation test
Participants With HPA Axis Suppression at Day 29
Number of participants with HPA axis suppression at Day 29, by measuring the level of cortisol in the blood after ACTH stimulation test

Secondary Outcome Measures

Full Information

First Posted
August 10, 2015
Last Updated
September 24, 2021
Sponsor
Encore Dermatology, Inc.
Collaborators
Prosoft Clinical
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1. Study Identification

Unique Protocol Identification Number
NCT02527421
Brief Title
DFD01 Spray HPA Axis Suppression Study in Adolescent Patients With Moderate to Severe Plaque Psoriasis
Official Title
A Randomized, Parallel Group, Open-Label, Multicenter Study to Assess the Potential for Adrenal Suppression and Systemic Drug Absorption Following Multiple Dosing With DFD-01 (Betamethasone Dipropionate) Spray, 0.05%
Study Type
Interventional

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Terminated
Why Stopped
Not able to recruit patients with the current enrollment criteria.
Study Start Date
August 19, 2015 (Actual)
Primary Completion Date
March 30, 2019 (Actual)
Study Completion Date
March 30, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Encore Dermatology, Inc.
Collaborators
Prosoft Clinical

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
To evaluate the potential of DFD-01 (betamethasone dipropionate) Spray, 0.05% to suppress the hypothalamic-pituitary-adrenal (HPA) axis.
Detailed Description
To evaluate the potential of DFD-01 (betamethasone dipropionate) Spray, 0.05% to suppress the hypothalamic-pituitary-adrenal (HPA) axis when applied twice daily for 15 days or when applied twice daily for 29 days, in adolescent subjects with moderate to severe plaque psoriasis under maximal use conditions.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
3 (Actual)

8. Arms, Groups, and Interventions

Arm Title
DFD01 Spray Group 1
Arm Type
Experimental
Arm Description
DFD01 spray, twice daily, 15 days
Arm Title
DFD01 Spray Group 2
Arm Type
Experimental
Arm Description
DFD01 spray, twice daily, 29 days
Intervention Type
Drug
Intervention Name(s)
DFD01 Spray
Other Intervention Name(s)
betamethasone
Intervention Description
DFD-01 (betamethasone dipropionate) Spray, 0.05%
Primary Outcome Measure Information:
Title
Participants With HPA Axis Suppression at End of Treatment (Day 15 or Day 28) With Recovery 29 Days Later
Description
Number of participants with HPA axis suppression at End of Treatment (day 15 or day 28) with recovery 29 days later, by measuring the level of cortisol in the blood after ACTH stimulation test
Time Frame
End of Treatment (day 15 or day 28) with recovery 29 days later
Title
Participants With HPA Axis Suppression at Day 29
Description
Number of participants with HPA axis suppression at Day 29, by measuring the level of cortisol in the blood after ACTH stimulation test
Time Frame
Day 29

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Subjects must weigh at least 55 pounds Subjects must present with a clinical diagnosis of stable (at least 3 months) plaque psoriasis. Subjects with psoriasis involving ≥ 10% BSA, not including the face, scalp, groin, axillae and other intertriginous areas.. Subjects must have moderate to severe plaque psoriasis at the Baseline Visit. Subjects whose results from the screening ACTH stimulation test are considered normal (cortisol level >18 ug/dL at 30 minutes post stimulation) and show no other signs of abnormal HPA axis function or adrenal response. Exclusion Criteria: Current diagnosis of unstable forms of psoriasis including guttate, erythrodermic, exfoliative or pustular psoriasis. History of organ transplant requiring immunosuppression, HIV, or other immunocompromised state. Have received treatment for any type of cancer within 5 years of the Baseline Visit. Use within 60 days prior to the Baseline Visit of: 1) immunosuppressive drugs (e.g., tacrolimus, pimecrolimus), 2) systemic antipsoriatic treatment (e.g., methotrexate, cyclosporine, hydroxyurea), or 3) biologic treatment for psoriasis (e.g., infliximab, adalimumab, etanercept, ustekinumab, secukinumab, or alefacept). Use within 30 days prior to the Baseline Visit of: 1) topical antipsoriatic drugs (salicylic acid, anthralin, coal tar, calcipotriene), 2) PUVA therapy, 3) systemic anti-inflammatory agents (e.g., mycophenolate mofetil, sulfasalazine, 6-thioguanine), or 4) UVB therapy. Use within 30 days prior to the Screening Visit of any product containing corticosteroids. Inhaled, intraocular, intranasal, etc. steroids are not allowed. Subjects who have an abnormal sleep schedule or work overnight. Subjects with a known history of acute adrenal crisis, Addison's disease or decreased adrenal output, low pituitary function or pituitary tumors. Subjects who have a history of an adverse reaction to cosyntropin injection or similar test reagents.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Srinivas Sidgiddi, MD
Organizational Affiliation
Dr. Reddy's Laboratories, Inc
Official's Role
Study Director
Facility Information:
Facility Name
Site 102
City
Encino
State/Province
California
ZIP/Postal Code
91436
Country
United States
Facility Name
Site 104
City
Irvine
State/Province
California
ZIP/Postal Code
92697-1385
Country
United States
Facility Name
Site 100
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States
Facility Name
Site 109
City
Lebanon
State/Province
New Hampshire
ZIP/Postal Code
03756
Country
United States
Facility Name
Site 107
City
New York
State/Province
New York
ZIP/Postal Code
10155
Country
United States
Facility Name
Site 106
City
Arlington
State/Province
Texas
ZIP/Postal Code
76014
Country
United States
Facility Name
Site 101
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Site 105
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78218
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

DFD01 Spray HPA Axis Suppression Study in Adolescent Patients With Moderate to Severe Plaque Psoriasis

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