A Comparison of DFD01 Spray Versus Vehicle Spray in Subjects With Moderate Psoriasis
- Conditions
- Psoriasis
- Interventions
- Drug: DFD01 SprayDrug: Vehicle Spray
- Registration Number
- NCT01967069
- Lead Sponsor
- Primus Pharmaceuticals
- Brief Summary
The objectives of this study are to compare the efficacy and safety of DFD01 Spray to Vehicle Spray for topical treatment of moderate plaque psoriasis
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 277
Subjects must present with a clinical diagnosis of stable (at least 3 months) plaque-type psoriasis.
Subjects with psoriasis involving 10 to 20% BSA, not including the face, scalp, groin, axillae and other intertriginous areas.
Subjects must have an IGA grade of 3 (moderate) at the Baseline Visit
Current diagnosis of unstable forms of psoriasis including guttate, erythrodermic, exfoliative or pustular psoriasis Other inflammatory skin disease that may confound the evaluation of the plaque psoriasis (e.g., atopic dermatitis, contact dermatitis, tinea corporis).
Presence of pigmentation, extensive scarring, or pigmented lesions or sunburn which could interfere with the rating of efficacy parameters.
History of psoriasis unresponsive to topical treatments. History of organ transplant requiring immunosuppression, HIV, or other immunocompromised state.
Use within 180 days prior to Baseline Visit of biologic treatment for psoriasis (e.g., infliximab, adalimumab, etanercept, ustekinumab, or alefacept).
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 within 1 year of the Baseline Visit.
Use within 60 days prior to the Baseline Visit of: 1) immunosuppressive drugs (e.g., tacrolimus, pimecrolimus), 2) systemic antipsoriatic treatment (e.g., methotrexate, cyclosporine, hydroxyurea) or 3) oral retinoids (e.g., acitretin, isotretinoin).
Use within 30 days prior to the Baseline Visit of: 1) systemic steroids, 2) PUVA therapy, 3) systemic anti-inflammatory agents (e.g., mycophenolate mofetil, sulfasalazine, 6-thioguanine), or 4) UVB therapy. Inhaled, intraocular, and intranasal steroids are allowed.
Use within 14 days prior to the Baseline Visit of: 1) topical antipsoriatic drugs (e.g., salicylic acid, anthralin, coal tar, calcipotriene), 2) topical retinoids (e.g., tazarotene, tretinoin) or 3) topical corticosteroids.
Require use of beta blockers, lithium, ACE inhibitors, and/or NSAIDs (indomethacin, ibuprofen, aspirin, naproxen) with a medical history that these medications affect the subject's psoriasis, except if the subject has been using the medication routinely during the 180 days prior to the Baseline Visit, these medications are allowed.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description DFD01 Spray DFD01 Spray DFD01 Spray twice daily Vehicle Spray Vehicle Spray Vehicle Spray twice daily
- Primary Outcome Measures
Name Time Method Percentage of Participants With Treatment Success According to the Investigator's Global Assessment (IGA) Day 15 IGA of clear or almost clear
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (28)
Hudson Dermatology/Clinical Research Advantage
🇺🇸Tempe, Arizona, United States
Augusta Centre for Dermatology and Skin Renewal, LLC
🇺🇸Augusta, Georgia, United States
Grekin Skin Institute
🇺🇸Warren, Michigan, United States
Paddington Testing Company, Inc.
🇺🇸Philadelphia, Pennsylvania, United States
Bettencourt Skin Center
🇺🇸Henderson, Nevada, United States
Center for Clinical Studies, LTD, LLP
🇺🇸Houston, Texas, United States
FXM Research Corop.
🇺🇸Miami, Florida, United States
Henry Ford Medical Center, New Center One
🇺🇸Detroit, Michigan, United States
Progressive Clinical Reesearch, PA
🇺🇸San Antonio, Texas, United States
Skin Care Research, Inc.
🇺🇸Boca Raton, Florida, United States
Dr. Tory P. Sullivan, MD, PA
🇺🇸North Miami Beach, Florida, United States
Coastal Clinical Research, Inc.
🇺🇸Mobile, Alabama, United States
Dermatology Specialists, Inc.
🇺🇸Oceanside, California, United States
Clinical Science Institute
🇺🇸Santa Monica, California, United States
Skin Search of Rochester, Inc.
🇺🇸Rochester, New York, United States
Radiant Research, Inc.
🇺🇸Cincinnati, Ohio, United States
Dermatology Clinical Research Center of San Antonio
🇺🇸San Antonio, Texas, United States
Charlottesville Medical Research Center, LLC
🇺🇸Charlottesville, Virginia, United States
University Clinical Trials, Inc
🇺🇸San Diego, California, United States
MOORE Clinical Research, Inc.
🇺🇸Brandon, Florida, United States
MLFKnuckles, MD, PSC
🇺🇸Corbin, Kentucky, United States
Gwinnett Clinical Research Center, Inc.
🇺🇸Snellville, Georgia, United States
Hamzavi Dermatology
🇺🇸Fort Gratiot, Michigan, United States
Brodell Medical, Inc.
🇺🇸Warren, Ohio, United States
Eastern Washington Dermatology
🇺🇸Walla Walla, Washington, United States
Shondra L. Smith, MD Dermatology & Advanced Aesthetics
🇺🇸Lake Charles, Louisiana, United States
Horizons Clinical Research Center, LLC
🇺🇸Denver, Colorado, United States
Skin Specialists P.C.
🇺🇸Omaha, Nebraska, United States