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

Psoriasis Clinical Trial

— HPA axis  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02131324
• Other study ID #: DFD06-CD-007
• Status: Completed
• Phase: Phase 2
• Start date: May 8, 2014
• Est. completion date: August 11, 2016

Study information

• Verified date: April 2018
• Source: Promius Pharma, LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: August 11, 2016
• Est. primary completion date: April 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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.

Related Conditions & MeSH terms

• Psoriasis

Intervention

Drug:
• DFD06 Cream

• Clobetasol Propionate Cream 0.05%

Locations

Country	Name	City	State
United States	T. Joseph Raoof, MD, Inc.	Encino	California
United States	Advanced Research Associates	Glendale	Arizona
United States	Radiant Research, Inc.	Greer	South Carolina
United States	Dermatology Consulting Services	High Point	North Carolina
United States	Clinical Partners, LLC	Johnston	Rhode Island
United States	Determatology Specialists Research, LLC	Louisville	Kentucky
United States	Marietta Dermatology Clinical Research, Inc.	Marietta	Georgia
United States	Agave Clinical Research, LLC	Mesa	Arizona
United States	FXM Research Corp.	Miami	Florida
United States	International Dermatology Research, Inc.	Miami	Florida
United States	FXM Research Miramar	Miramar	Florida
United States	Lynn Health Science Institute	Oklahoma City	Oklahoma
United States	Quality Clinical Research, Inc.	Omaha	Nebraska
United States	Belleair Research	Pinellas Park	Florida
United States	Forward Clinical Trials	Tampa	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Promius Pharma, LLC

Country where clinical trial is conducted

United States, 

Outcome

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