DFD06 Cream vs Clobetasol Propionate Cream, 0.05% Hypothalamic- Pituitary-Adrenal (HPA) Axis Suppression Study in Patients With Moderate to Severe Plaque Psoriasis
- Conditions
- Psoriasis
- Interventions
- Drug: DFD06 Cream
- Registration Number
- NCT02131324
- Lead Sponsor
- Promius Pharma, LLC
- 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.
- Detailed Description
This was a 15-day, randomized, multicenter, comparator-controlled, open-label study. Approximately 50 subjects with moderate to severe plaque psoriasis were to be randomized to treatment with DFD-06 Cream or clobetasol propionate cream in a 1:1 ratio. Study products were applied twice daily for 15 days to all affected areas on the body excluding face, scalp, groin, axillae, and other intertriginous areas. Subject visits were scheduled at Screening, Baseline (Day 1), Day 8, Day 15, and Day 43 (if needed to confirm recovery). Clinical determinations of disease severity were conducted using the Investigator's Global Assessment (IGA) for overall severity at each visit.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 50
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
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Clobetasol Propionate Cream, 0.05% Clobetasol Propionate Cream 0.05% applied twice a day for 15 days DFD06 Cream DFD06 Cream applied twice a day for 15 days
- Primary Outcome Measures
Name Time Method The Percentage of Subjects With HPA Axis Suppression. Day 15 HPA axis suppression as measured by serum cortisol levels post cosyntropin test (ACTH test)
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (15)
Advanced Research Associates
🇺🇸Glendale, Arizona, United States
Lynn Health Science Institute
🇺🇸Oklahoma City, Oklahoma, United States
Agave Clinical Research, LLC
🇺🇸Mesa, Arizona, United States
Forward Clinical Trials
🇺🇸Tampa, Florida, United States
International Dermatology Research, Inc.
🇺🇸Miami, Florida, United States
T. Joseph Raoof, MD, Inc.
🇺🇸Encino, California, United States
Belleair Research
🇺🇸Pinellas Park, Florida, United States
FXM Research Corp.
🇺🇸Miami, Florida, United States
FXM Research Miramar
🇺🇸Miramar, Florida, United States
Determatology Specialists Research, LLC
🇺🇸Louisville, Kentucky, United States
Dermatology Consulting Services
🇺🇸High Point, North Carolina, United States
Quality Clinical Research, Inc.
🇺🇸Omaha, Nebraska, United States
Radiant Research, Inc.
🇺🇸Greer, South Carolina, United States
Clinical Partners, LLC
🇺🇸Johnston, Rhode Island, United States
Marietta Dermatology Clinical Research, Inc.
🇺🇸Marietta, Georgia, United States