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
1 other identifier
interventional
75
1 country
12
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Jan 2014
Shorter than P25 for phase_2
12 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2014
CompletedFirst Submitted
Initial submission to the registry
February 21, 2014
CompletedFirst Posted
Study publicly available on registry
February 25, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2014
CompletedResults Posted
Study results publicly available
March 13, 2017
CompletedMarch 7, 2024
March 1, 2024
9 months
February 21, 2014
January 23, 2017
March 5, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
The Number of Subjects With HPA Axis Suppression
Day 15
Study Arms (3)
DFD01 Spray Group 1
EXPERIMENTALDFD01 Spray, bid, 28 days
Comp01 Lotion
ACTIVE COMPARATORComp01 Lotion, bid, 14 days
DFD01 Spray Group 2
EXPERIMENTALDFD01 Spray, bid, 14 days
Interventions
Eligibility Criteria
You may qualify if:
- Subjects must present with a clinical diagnosis of stable (at least 3 months) plaque psoriasis.
- Subjects with psoriasis involving 20 to 50% 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 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. -
You may not qualify if:
- 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) PUVA therapy, 3) systemic anti-inflammatory agents (e.g., mycophenolate mofetil, sulfasalazine, 6-thioguanine), or 4) 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Primus Pharmaceuticalslead
- Prosoft Clinicalcollaborator
Study Sites (12)
California Dermatology and Clinical Research Institute
Encinitas, California, 92024, United States
Encino Research Center T. Joseph Raoof MD, Inc.
Encino, California, 91436, United States
Redwood Dermatology Research
Santa Rosa, California, 95403, United States
Bettencourt Skin Center
Henderson, Nevada, 89074, United States
Academic Dermatology Associates
Albuquerque, New Mexico, 87106, United States
Dermatology Consulting Services
High Point, North Carolina, 27262, United States
Paddington Testing Company, Inc.
Philadelphia, Pennsylvania, 19101, United States
Tennessee Clinical Research Center
Nashville, Tennessee, 37215, United States
DermResearch, Inc.
Austin, Texas, 78759, United States
Center for Clinical Studies, LTD. LLP
Houston, Texas, 77004, United States
The University of Texas Health Science Center at Houston
Houston, Texas, 77030, United States
Suzanne Bruce and Associates, PA The Center for Skin Research Katy/Cinco Ranch
Katy, Texas, 77494, United States
Related Publications (1)
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.
PMID: 29657667DERIVED
Results Point of Contact
- Title
- Director of Clinical Operations
- Organization
- Promius Pharma, LLC
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- GT60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 21, 2014
First Posted
February 25, 2014
Study Start
January 1, 2014
Primary Completion
October 1, 2014
Study Completion
October 1, 2014
Last Updated
March 7, 2024
Results First Posted
March 13, 2017
Record last verified: 2024-03