NCT01967069CompletedPhase 3
A Comparison of DFD01 Spray Versus Vehicle Spray in Subjects With Moderate Psoriasis
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Primus Pharmaceuticals
- Enrollment
- 277
- Locations
- 28
- Primary Endpoint
- Percentage of Participants With Treatment Success According to the Investigator's Global Assessment (IGA)
Study Overview
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
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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
Exclusion Criteria
- •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.
Arms & Interventions
Vehicle Spray
Placebo Comparator
Vehicle Spray twice daily
Intervention: Vehicle Spray (Drug)
DFD01 Spray
Active Comparator
DFD01 Spray twice daily
Intervention: DFD01 Spray (Drug)
Outcomes
Primary Outcomes
Percentage of Participants With Treatment Success According to the Investigator's Global Assessment (IGA)
Time Frame: Day 15
IGA of clear or almost clear
Secondary Outcomes
No secondary outcomes reported
Investigators
Study Sites (28)
Loading locations...
Similar Trials
Completed
Phase 3
A Comparison of DFD01 Spray Versus Comp01 Lotion, Vehicle Spray and Vehicle Lotion in Subjects With Moderate PsoriasisPsoriasisNCT01947491Primus Pharmaceuticals394
Not yet recruiting
Phase 2
Dried form of Rasnadi Ksheerapaka versus Shatapushpa Curna in Kastartava (Primary Dysmenorrhea)- Clinical StudyCTRI/2024/02/062320I
Completed
Phase 3
A Study of the Efficacy and Safety of DFD-06 Cream in the Treatment of Moderate to Severe Plaque PsoriasisChronic Stable Plaque PsoriasisNCT02445807Promius Pharma, LLC265
Completed
Phase 3
A Study of the Efficacy and Safety of DFD-06 Cream in the Treatment of Moderate to Severe Plaque PsoriasisPsoriasisNCT02635204Promius Pharma, LLC267
Completed
Not Applicable
A Comparison of Capsules and Oral Spray Solution as Methods of Delivering Vitamin D3 and Raising StatusVitamin D ConcentrationVitamin D StatusNCT02608164University of Ulster22