DFD01 Spray vs Comp01 Lotion HPA Axis Suppression Study in Patients With Moderate to Severe Plaque Psoriasis
NCT ID: NCT02070965
Last Updated: 2024-03-07
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
75 participants
INTERVENTIONAL
2014-01-31
2014-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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DFD01 Spray Group 1
DFD01 Spray, bid, 28 days
DFD01 Spray
Comp01 Lotion
Comp01 Lotion, bid, 14 days
Comp01 Lotion
DFD01 Spray Group 2
DFD01 Spray, bid, 14 days
DFD01 Spray
Interventions
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DFD01 Spray
Comp01 Lotion
Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
90 Years
ALL
No
Sponsors
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Prosoft Clinical
OTHER
Primus Pharmaceuticals
INDUSTRY
Responsible Party
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Locations
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California Dermatology and Clinical Research Institute
Encinitas, California, United States
Encino Research Center T. Joseph Raoof MD, Inc.
Encino, California, United States
Redwood Dermatology Research
Santa Rosa, California, United States
Bettencourt Skin Center
Henderson, Nevada, United States
Academic Dermatology Associates
Albuquerque, New Mexico, United States
Dermatology Consulting Services
High Point, North Carolina, United States
Paddington Testing Company, Inc.
Philadelphia, Pennsylvania, United States
Tennessee Clinical Research Center
Nashville, Tennessee, United States
DermResearch, Inc.
Austin, Texas, 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
Countries
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References
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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.
Other Identifiers
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BDS1307
Identifier Type: -
Identifier Source: org_study_id
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