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)

• 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: Promius Pharma, LLC
• Information provided by (Responsible Party): Promius Pharma, LLC

Study Description

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.

Study Design

• 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

Arms and Interventions

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

Outcome Measures

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)

Eligibility Criteria

• 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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Contacts and Locations

Locations

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

• Study Director: Srinivas Sidgiddi, MD; Dr. Reddy's Laboratories, Inc

More Information

• Responsible Party: Promius Pharma, LLC
• ClinicalTrials.gov Identifier: NCT02131324
• Other Study ID Numbers: DFD06-CD-007
• First Posted: May 6, 2014
• 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

• 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:

Psoriasis; Skin Diseases, Papulosquamous; Skin Diseases; Clobetasol; Anti-Inflammatory Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Physiological Effects of Drugs