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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)

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ClinicalTrials.gov Identifier: NCT02131324
Recruitment Status : Completed
First Posted : May 6, 2014
Results First Posted : April 18, 2018
Last Update Posted : May 18, 2018
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Psoriasis Drug: DFD06 Cream Drug: Clobetasol Propionate Cream 0.05% Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : May 8, 2014
Actual Primary Completion Date : April 2016
Actual Study Completion Date : August 11, 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Psoriasis

Arm Intervention/treatment
Active Comparator: Clobetasol Propionate Cream, 0.05%
applied twice a day for 15 days
Drug: Clobetasol Propionate Cream 0.05%
Other Name: Temovate Cream

Experimental: DFD06 Cream
applied twice a day for 15 days
Drug: DFD06 Cream
Other Name: Clobetasol Propionate 0.025% Cream




Primary Outcome Measures :
  1. The Percentage of Subjects With HPA Axis Suppression. [ Time Frame: Day 15 ]
    HPA axis suppression as measured by serum cortisol levels post cosyntropin test (ACTH test)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

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 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.

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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): NCT02131324


Locations
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United States, Arizona
Advanced Research Associates
Glendale, Arizona, United States, 85308
Agave Clinical Research, LLC
Mesa, Arizona, United States, 85202
United States, California
T. Joseph Raoof, MD, Inc.
Encino, California, United States, 91436
United States, Florida
International Dermatology Research, Inc.
Miami, Florida, United States, 33144
FXM Research Corp.
Miami, Florida, United States, 33175
FXM Research Miramar
Miramar, Florida, United States, 33027
Belleair Research
Pinellas Park, Florida, United States, 33781
Forward Clinical Trials
Tampa, Florida, United States, 33624
United States, Georgia
Marietta Dermatology Clinical Research, Inc.
Marietta, Georgia, United States, 30060
United States, Kentucky
Determatology Specialists Research, LLC
Louisville, Kentucky, United States, 40202
United States, Nebraska
Quality Clinical Research, Inc.
Omaha, Nebraska, United States, 68114
United States, North Carolina
Dermatology Consulting Services
High Point, North Carolina, United States, 27262
United States, Oklahoma
Lynn Health Science Institute
Oklahoma City, Oklahoma, United States, 73112
United States, Rhode Island
Clinical Partners, LLC
Johnston, Rhode Island, United States, 02919
United States, South Carolina
Radiant Research, Inc.
Greer, South Carolina, United States, 29650
Sponsors and Collaborators
Promius Pharma, LLC
Investigators
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Study Director: Srinivas Sidgiddi, MD Dr. Reddy's Laboratories, Inc

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Responsible Party: Promius Pharma, LLC
ClinicalTrials.gov Identifier: NCT02131324     History of Changes
Other Study ID Numbers: DFD06-CD-007
First Posted: May 6, 2014    Key Record Dates
Results First Posted: April 18, 2018
Last Update Posted: May 18, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Promius Pharma, LLC:
Psoriasis
Additional relevant MeSH terms:
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Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases
Clobetasol
Physiological Effects of Drugs
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists