DFD01 Spray vs Comp01 Lotion HPA Axis Suppression Study in Patients With Moderate to Severe Plaque Psoriasis (BDS1307)

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

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.

Study Overview

• Status: Completed
• Conditions: Plaque Psoriasis
• Intervention / Treatment: Drug: DFD01 Spray; Drug: Comp01 Lotion

• Study Type: Interventional
• Enrollment (Actual): 75
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • California
    • Encinitas, California, United States, 92024
      • California Dermatology and Clinical Research Institute
    • Encino, California, United States, 91436
      • Encino Research Center T. Joseph Raoof MD, Inc.
    • Santa Rosa, California, United States, 95403
      • Redwood Dermatology Research
  • Nevada
    • Henderson, Nevada, United States, 89074
      • Bettencourt Skin Center
  • New Mexico
    • Albuquerque, New Mexico, United States, 87106
      • Academic Dermatology Associates
  • North Carolina
    • High Point, North Carolina, United States, 27262
      • Dermatology Consulting Services
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19101
      • Paddington Testing Company, Inc.
  • Tennessee
    • Nashville, Tennessee, United States, 37215
      • Tennessee Clinical Research Center
  • Texas
    • Austin, Texas, United States, 78759
      • Dermresearch, Inc.
    • Houston, Texas, United States, 77030
      • The University of Texas Health Science Center at Houston
    • Houston, Texas, United States, 77004
      • Center for Clinical Studies, LTD. LLP
    • Katy, Texas, United States, 77494
      • Suzanne Bruce and Associates, PA The Center for Skin Research Katy/Cinco Ranch

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

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

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: DFD01 Spray Group 1; DFD01 Spray, bid, 28 days	Drug: DFD01 Spray
Active Comparator: Comp01 Lotion; Comp01 Lotion, bid, 14 days	Drug: Comp01 Lotion
Experimental: DFD01 Spray Group 2; DFD01 Spray, bid, 14 days	Drug: DFD01 Spray

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
The Number of Subjects With HPA Axis Suppression	Day 15

Collaborators and Investigators

• Sponsor: Primus Pharmaceuticals
• Collaborators: Prosoft Clinical

Publications and helpful links

General Publications

• Sidgiddi S, Pakunlu RI, Allenby K. Efficacy, Safety, and Potency of Betamethasone Dipropionate Spray 0.05%: A Treatment for Adults with Mild-to-moderate Plaque Psoriasis. J Clin Aesthet Dermatol. 2018 Apr;11(4):14-22. Epub 2018 Apr 1.

Study record dates

Study Major Dates

• Study Start: January 1, 2014
• Primary Completion (Actual): October 1, 2014
• Study Completion (Actual): October 1, 2014

Study Registration Dates

• First Submitted: February 21, 2014
• First Submitted That Met QC Criteria: February 21, 2014
• First Posted (Estimated): February 25, 2014

Study Record Updates

• Last Update Posted (Actual): March 7, 2024
• Last Update Submitted That Met QC Criteria: March 5, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Skin Diseases, Papulosquamous; Psoriasis
• Other Study ID Numbers: BDS1307