DFD06 Cream vs Clobetasol Propionate Cream, 0.05% Hypothalamic- Pituitary-Adrenal (HPA) Axis Suppression Study in Patients With Moderate to Severe Plaque Psoriasis

NCT ID: NCT02131324

Last Updated: 2018-05-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-05-08
• Study Completion Date: 2016-08-11

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.

Conditions

Psoriasis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Clobetasol Propionate Cream, 0.05%

applied twice a day for 15 days

Group Type: ACTIVE_COMPARATOR

Clobetasol Propionate Cream 0.05%

Intervention Type: DRUG

DFD06 Cream

applied twice a day for 15 days

Group Type: EXPERIMENTAL

DFD06 Cream

Intervention Type: DRUG

Interventions

DFD06 Cream

Intervention Type: DRUG

Clobetasol Propionate Cream 0.05%

Intervention Type: DRUG

Other Intervention Names

Clobetasol Propionate 0.025% Cream; Temovate Cream

Eligibility 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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• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Promius Pharma, LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Srinivas Sidgiddi, MD

Role: STUDY_DIRECTOR

Dr. Reddy's Laboratories, Inc

Locations

Advanced Research Associates

Glendale, Arizona, United States

Agave Clinical Research, LLC

Mesa, Arizona, United States

T. Joseph Raoof, MD, Inc.

Encino, California, United States

International Dermatology Research, Inc.

Miami, Florida, United States

FXM Research Corp.

Miami, Florida, United States

FXM Research Miramar

Miramar, Florida, United States

Belleair Research

Pinellas Park, Florida, United States

Forward Clinical Trials

Tampa, Florida, United States

Marietta Dermatology Clinical Research, Inc.

Marietta, Georgia, United States

Determatology Specialists Research, LLC

Louisville, Kentucky, United States

Quality Clinical Research, Inc.

Omaha, Nebraska, United States

Dermatology Consulting Services

High Point, North Carolina, United States

Lynn Health Science Institute

Oklahoma City, Oklahoma, United States

Clinical Partners, LLC

Johnston, Rhode Island, United States

Radiant Research, Inc.

Greer, South Carolina, United States

Countries

United States

Other Identifiers

DFD06-CD-007

Identifier Type: -

Identifier Source: org_study_id