DFD06 Cream vs Clobetasol Propionate Cream, 0.05% Hypothalamic- Pituitary-Adrenal (HPA) Axis Suppression Study in Patients With Moderate to Severe Plaque Psoriasis
HPA axis
A Randomized, Open Label, Study to Assess the Potential for Adrenal Suppression and Systemic Drug Absorption With DFD-06 Cream Versus Clobetasol Propionate Cream, 0.05% in Subjects With Moderate to Severe Plaque Psoriasis
1 other identifier
interventional
50
1 country
15
Brief Summary
The purpose of this study is to evaluate the potential of DFD06 cream to suppress the HPA (hypothalamic-pituitary-adrenal) axis as compared to clobetasol propionate cream, 0.05% cream when applied twice daily for 15 days.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started May 2014
15 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 2, 2014
CompletedFirst Posted
Study publicly available on registry
May 6, 2014
CompletedStudy Start
First participant enrolled
May 8, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
August 11, 2016
CompletedResults Posted
Study results publicly available
April 18, 2018
CompletedMay 18, 2018
April 1, 2018
1.9 years
May 2, 2014
May 11, 2017
April 19, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The Percentage of Subjects With HPA Axis Suppression.
HPA axis suppression as measured by serum cortisol levels post cosyntropin test (ACTH test)
Day 15
Study Arms (2)
Clobetasol Propionate Cream, 0.05%
ACTIVE COMPARATORapplied twice a day for 15 days
DFD06 Cream
EXPERIMENTALapplied twice a day for 15 days
Interventions
Eligibility Criteria
You may qualify if:
- Subjects must present with a clinical diagnosis of stable (at least 3 months) plaque psoriasis.
- Subjects with psoriasis involving 20 to 50% Body Surface Area (BSA), not including the face, scalp, groin, axillae and other intertriginous areas.
- Subjects must have an IGA grade of at least 3 (moderate) at the Baseline Visit Subjects whose results from the screening Adrenocorticotropic hormone (ACTH) stimulation test are considered normal (cortisol level \>18 ug/dL at 30 minutes post stimulation) and show no other signs of abnormal HPA function or adrenal response
You may not qualify if:
- 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 except skin cancer and cervical cancer (in situ) are allowed if at least 1 year before the Baseline Visit.
- Use within 60 days prior to the baseline Visit of: 1) immunosuppressive drugs (e.g., tacrolimus, pimecrolimus), or 2) systemic antipsoriatic treatment (e.g., methotrexate, cyclosporine, hydroxyurea) Use within 30 days prior to the Baseline Visit of: 1) topical antipsoriatic drugs (salicylic acid, anthralin, coal tar, calcipotriene), 2) psoralen and ultraviolet A (PUVA) therapy, 3) systemic anti-inflammatory agents (e.g., mycophenolate mofetil, sulfasalazine, 6-thioguanine), or 4) ultraviolet B (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 at night. 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (15)
Advanced Research Associates
Glendale, Arizona, 85308, United States
Agave Clinical Research, LLC
Mesa, Arizona, 85202, United States
T. Joseph Raoof, MD, Inc.
Encino, California, 91436, United States
International Dermatology Research, Inc.
Miami, Florida, 33144, United States
FXM Research Corp.
Miami, Florida, 33175, United States
FXM Research Miramar
Miramar, Florida, 33027, United States
Belleair Research
Pinellas Park, Florida, 33781, United States
Forward Clinical Trials
Tampa, Florida, 33624, United States
Marietta Dermatology Clinical Research, Inc.
Marietta, Georgia, 30060, United States
Determatology Specialists Research, LLC
Louisville, Kentucky, 40202, United States
Quality Clinical Research, Inc.
Omaha, Nebraska, 68114, United States
Dermatology Consulting Services
High Point, North Carolina, 27262, United States
Lynn Health Science Institute
Oklahoma City, Oklahoma, 73112, United States
Clinical Partners, LLC
Johnston, Rhode Island, 02919, United States
Radiant Research, Inc.
Greer, South Carolina, 29650, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Srinivas Sidgiddi, MD
- Organization
- Dr. Reddy's Lab, Inc
Study Officials
- STUDY DIRECTOR
Srinivas Sidgiddi, MD
Dr. Reddy's Laboratories, Inc
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- LTE60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 2, 2014
First Posted
May 6, 2014
Study Start
May 8, 2014
Primary Completion
April 1, 2016
Study Completion
August 11, 2016
Last Updated
May 18, 2018
Results First Posted
April 18, 2018
Record last verified: 2018-04
Data Sharing
- IPD Sharing
- Will not share