DFD01 Spray vs Comp01 Lotion HPA Axis Suppression Study in Patients With Moderate to Severe Plaque Psoriasis

Plaque Psoriasis Clinical Trial

— BDS1307  

Official title:

Randomized Parallel Group Open-Label Multicenter Study to Assess the Potential for Adrenal Supp and Syst Drug Abs Following Multi Dosing With DFD-01 (Betamethasone Dipropionate) Spray 0.05% in Adol Subjects With Mod to Sev Plaque Psoriasis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02070965
• Other study ID #: BDS1307
• Status: Completed
• Phase: Phase 2
• Start date: January 2014
• Est. completion date: October 2014

Study information

• Verified date: March 2024
• Source: Primus Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the potential of DFD01 spray to suppress the HPA (hypothalamic-pituitary-adrenal) axis as compared to Comp01 lotion when applied twice daily for 15 days.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 75
• Est. completion date: October 2014
• Est. primary completion date: October 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

Inclusion Criteria:

1. Subjects must present with a clinical diagnosis of stable (at least 3 months) plaque psoriasis.

2. Subjects with psoriasis involving 20 to 50% BSA, not including the face, scalp, groin, axillae and other intertriginous areas.

3. Subjects must have an IGA grade of at least 3 (moderate) at the Baseline Visit

4. Subjects whose results from the screening 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:

1. Current diagnosis of unstable forms of psoriasis including guttate, erythrodermic, exfoliative or pustular psoriasis.

2. History of organ transplant requiring immunosuppression, HIV, or other immunocompromised state.

3. 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.

4. 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)

5. Use within 30 days prior to the Baseline Visit of: 1) topical antipsoriatic drugs (salicylic acid, anthralin, coal tar, calcipotriene)2) PUVA therapy, 3) systemic anti-inflammatory agents (e.g., mycophenolate mofetil, sulfasalazine, 6-thioguanine), or 4) UVB therapy.

6. Use within 30 days prior to the Screening Visit of any product containing corticosteroids. Inhaled, intraocular, intranasal, etc. steroids are not allowed.

7. Subjects who have an abnormal sleep schedule or work at night.

8. Subjects with a known history of acute adrenal crisis, Addison's disease or decreased adrenal output, low pituitary function or pituitary tumors.

9. Subjects who have a history of an adverse reaction to cosyntropin injection or similar test reagents.

Related Conditions & MeSH terms

• Plaque Psoriasis
• Psoriasis

Intervention

Drug:
• DFD01 Spray

• Comp01 Lotion

Locations

Country	Name	City	State
United States	Academic Dermatology Associates	Albuquerque	New Mexico
United States	DermResearch, Inc.	Austin	Texas
United States	California Dermatology and Clinical Research Institute	Encinitas	California
United States	Encino Research Center T. Joseph Raoof MD, Inc.	Encino	California
United States	Bettencourt Skin Center	Henderson	Nevada
United States	Dermatology Consulting Services	High Point	North Carolina
United States	Center for Clinical Studies, LTD. LLP	Houston	Texas
United States	The University of Texas Health Science Center at Houston	Houston	Texas
United States	Suzanne Bruce and Associates, PA The Center for Skin Research Katy/Cinco Ranch	Katy	Texas
United States	Tennessee Clinical Research Center	Nashville	Tennessee
United States	Paddington Testing Company, Inc.	Philadelphia	Pennsylvania
United States	Redwood Dermatology Research	Santa Rosa	California

Sponsors (2)

Lead Sponsor	Collaborator
Primus Pharmaceuticals	Prosoft Clinical

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The Number of Subjects With HPA Axis Suppression		Day 15