Psoriasis
Conditions
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
Interventions
DRUGDFD01 Spray
DRUGVehicle Spray
Sponsors
Prosoft Clinical
Primus Pharmaceuticals
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Treatment Success According to the Investigator's Global Assessment (IGA) | Day 15 | IGA of clear or almost clear |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| DFD01 Spray DFD01 Spray twice daily
DFD01 Spray | 182 |
| Vehicle Spray Vehicle Spray twice daily
Vehicle Spray | 95 |
| Total | 277 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 2 | 2 |
| Overall Study | Lack of Efficacy | 0 | 1 |
| Overall Study | Lost to Follow-up | 5 | 2 |
| Overall Study | Withdrawal by Subject | 1 | 3 |
Baseline characteristics
| Characteristic | Vehicle Spray | Total | DFD01 Spray |
|---|---|---|---|
| Age, Continuous | 49.9 years STANDARD_DEVIATION 12.9 | 50.2 years STANDARD_DEVIATION 14.1 | 50.3 years STANDARD_DEVIATION 14.72 |
| % Body Surface Area | 13.4 Percent STANDARD_DEVIATION 3.49 | 13.6 Percent STANDARD_DEVIATION 3.64 | 13.7 Percent STANDARD_DEVIATION 3.72 |
| Participants with Moderate Psoriasis According to the Investigator's Global Assessment (IGA) | 95 Participants | 277 Participants | 182 Participants |
| Region of Enrollment United States | 95 participants | 277 participants | 182 participants |
| Sex: Female, Male Female | 37 Participants | 105 Participants | 68 Participants |
| Sex: Female, Male Male | 58 Participants | 172 Participants | 114 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 17 / 179 | 24 / 93 |
| serious Total, serious adverse events | 1 / 179 | 2 / 93 |
Outcome results
Primary
Percentage of Participants With Treatment Success According to the Investigator's Global Assessment (IGA)
IGA of clear or almost clear
Time frame: Day 15
Population: Intent to Treat
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| DFD01 Spray | Percentage of Participants With Treatment Success According to the Investigator's Global Assessment (IGA) | 21.50 percentage of subjects |
| Vehicle Spray | Percentage of Participants With Treatment Success According to the Investigator's Global Assessment (IGA) | 7.4 percentage of subjects |