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

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.

Study Overview

• Status: Completed
• Conditions: Psoriasis
• Intervention / Treatment: Drug: Clobetasol Propionate Cream 0.05%; Drug: DFD06 Cream

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 Type: Interventional
• Enrollment (Actual): 50
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Glendale, Arizona, United States, 85308
      • Advanced Research Associates
    • Mesa, Arizona, United States, 85202
      • Agave Clinical Research, LLC
  • California
    • Encino, California, United States, 91436
      • T. Joseph Raoof, MD, Inc.
  • Florida
    • Miami, Florida, United States, 33175
      • FXM Research Corp.
    • Miami, Florida, United States, 33144
      • International Dermatology Research, Inc.
    • Miramar, Florida, United States, 33027
      • FXM Research Miramar
    • Pinellas Park, Florida, United States, 33781
      • Belleair Research
    • Tampa, Florida, United States, 33624
      • Forward Clinical Trials
  • Georgia
    • Marietta, Georgia, United States, 30060
      • Marietta Dermatology Clinical Research, Inc.
  • Kentucky
    • Louisville, Kentucky, United States, 40202
      • Determatology Specialists Research, LLC
  • Nebraska
    • Omaha, Nebraska, United States, 68114
      • Quality Clinical Research, Inc.
  • North Carolina
    • High Point, North Carolina, United States, 27262
      • Dermatology Consulting Services
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73112
      • Lynn Health Science Institute
  • Rhode Island
    • Johnston, Rhode Island, United States, 02919
      • Clinical Partners, LLC
  • South Carolina
    • Greer, South Carolina, United States, 29650
      • Radiant Research, Inc.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 88 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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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Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Clobetasol Propionate Cream, 0.05%; applied twice a day for 15 days	Drug: Clobetasol Propionate Cream 0.05%; Other Names: Temovate Cream
Experimental: DFD06 Cream; applied twice a day for 15 days	Drug: DFD06 Cream; Other Names: Clobetasol Propionate 0.025% Cream

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The Percentage of Subjects With HPA Axis Suppression.	HPA axis suppression as measured by serum cortisol levels post cosyntropin test (ACTH test)	Day 15

Collaborators and Investigators

• Sponsor: Promius Pharma, LLC

Study record dates

Study Major Dates

• Study Start (Actual): May 8, 2014
• Primary Completion (Actual): April 1, 2016
• Study Completion (Actual): August 11, 2016

Study Registration Dates

• First Submitted: May 2, 2014
• First Submitted That Met QC Criteria: May 2, 2014
• First Posted (Estimate): May 6, 2014

Study Record Updates

• Last Update Posted (Actual): May 18, 2018
• Last Update Submitted That Met QC Criteria: April 19, 2018
• Last Verified: April 1, 2018

More Information

Terms related to this study

• Keywords: Psoriasis
• Additional Relevant MeSH Terms: Skin Diseases; Skin Diseases, Papulosquamous; Psoriasis; Physiological Effects of Drugs; Anti-Inflammatory Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Clobetasol
• Other Study ID Numbers: DFD06-CD-007

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No